Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 6:15 PM
Study NCT ID:
NCT04355728
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2020-04-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of UC-MSCs for COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ricordi@miami.edu', 'phone': '305-243-6913', 'title': 'Camillo Ricordi', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The inferences we make from the efficacy results observed in this phase 1/2a trial in 24 subjects, including the outcome of survival, are still subject to limitations of sample size and potential bias because of factors we were not yet aware of.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 7, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Exacerbation of COVID ARDS-Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Tachycardia after infusion of Investigational Product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Clostridium Difficile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Mild Gastrointestinal Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Transaminitis/Transaminitis-Liver Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Increased ALT, AST, and Alkaline Phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Increased Direct Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Abnormal Urinalysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Candiduria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Leukocytosis/Leukocytosis (Increased WBC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Severe Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Thrombocytopenia/Heparin-induced Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Bilateral Common Femoral Vein DVT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Candida Albicans Fungemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Mild Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'MRSA Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Paenebacillus Pabuli Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Positive Blood Culture Streptococcus Mitis and Streptococcus Oralis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Staphylococcus haemolyticus bacteremia and Candida orthopsilosi Fungemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Staphylococcus Hominis Bacteremia/Staphylococcus Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Left Calf Collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Dysconjugated gaze', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Acute Kidney Injury/Oliguric Acute Kidney Injury/ Anuric Acute Kidney Injury/Acute Kidney Injury (AK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Aspiration Pneumonitis, suspected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Bradypnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Enterococcus Faecalis, Klebsiella Pneumoniae, Candida Auris/Duobushaemulonis in bronchial aspirate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Enterococcus Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'MRSA Hospital Acquired Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Respiratory Failure - Intubation/Hypoxemic respiratory failure requiring intubation and mechanical v', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Subcutaneous Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Ventilator Acquired Pneumonia (VAP) with Pseudomona aureginosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Worsening of Hypoxemia/Deterioration of Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}], 'seriousEvents': [{'term': 'GI Bleeding 2ry to Clostridium Difficile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Colon Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Cardiact Arrest-Death due to Difficult Intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Acute respiratory Failure 2ry to COVID-Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Death-Acute Hypoxemic Respiratory Failure Secondary to COVID-19 Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Cardiac Arrest/Pulseless Electrical Activity Cardiac Arrest/Cardiac Arrest Secondary to Acute Respir', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Traumatic Tension Pneumotorax post-CPR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Severe Respiratory Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': '[DEATH] Multisystem Organ Failure (Death)/Multiple Organ Dysfunction Syndrome-Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': '[DEATH] Cardiac Arrest-Death/Cardiopulmonary Arrest-Death/Asystole -Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Severe Metabolic Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}, {'term': 'Septic Shock-Hospital acquired Pseudomona Aeruginosa bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE Version 5.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Pre-Specified Infusion Associated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Number of subjects with an increase in vasopressor dose at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Number of subjects with cardiac arrest or death within 24 h post infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 24 hours', 'description': 'Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:\n\n1. An increase in vasopressor dose greater than or equal to the following:\n\n * Norepinephrine: 10 μg/min\n * Phenylephrine: 100 μg/min\n * Dopamine: 10 μg/kg/min\n * Epinephrine: 10 μg/min\n2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of \\>20%.\n3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.\n4. New cardiac arrhythmia requiring cardioversion\n5. New ventricular tachycardia, ventricular fibrillation, or asystole\n6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection\n7. Cardiac arrest or death within 24h post infusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group, 4 participants were on mechanical ventilation and 8 participants were receiving high flow oxygen therapy. In the control group 7 participants were on mechanical ventilation and 5 participants were receiving high flow oxygen therapy.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events by 31 Days After First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.04', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '31 days', 'description': 'The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.67', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Number of Adverse Events (not including SAEs)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Number of Serious Adverse Events', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Total number of adverse events and serious adverse events as assessed by treating physician', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Total number of adverse events plus serious adverse events categorized by severity.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjects With Adverse Events and Serious Adverse Events by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Total number of subjects with adverse events and serious adverse events categorized by severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who experience one or more AEs or SAEs within each category are counted only once.'}, {'type': 'PRIMARY', 'title': 'Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Unrelated', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Unlikely', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Possible', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Probably', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Definite', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days', 'description': 'Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.', 'unitOfMeasure': 'Adverse Events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjects With Adverse Events by Relatedness to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Unrelated', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Unlikely', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Possible', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Probable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Defininte', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Survival at 31 Days Post First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '31 Days', 'description': 'Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the UC-MSC Group was not included in the data analysis due to failed intubation.'}, {'type': 'SECONDARY', 'title': 'Survival at 60 Days Post First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Number of participants alive at 60 days post first infusion follow up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject was censored due to failed intubation in the UC-MSC group.'}, {'type': 'SECONDARY', 'title': 'Time to Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Days by which 75% of subjects were recovered', 'categories': [{'measurements': [{'value': '23', 'comment': 'insufficient number of people recovered within 31 day limit to estimate the upper confidence', 'groupId': 'OG000', 'lowerLimit': '13.00', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'insufficient number of people recovered within 31 day limit', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Days by which 50% of subjects were recovered', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '23'}, {'value': 'NA', 'comment': 'insufficient number of people recovered within 31 day limit', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': 'NA'}]}]}, {'title': 'Days by which 25% of subjects were recovered', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '15'}, {'value': '12', 'comment': 'insufficient number of people recovered within 31 day limit to estimate the upper confidence', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.289', 'ciLowerLimit': '0.088', 'ciUpperLimit': '0.948', 'estimateComment': "Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.", 'groupDescription': 'The null hypothesis is the following: "There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group". Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '31 days', 'description': 'Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilator-Free Days Throughout 28 Days Post Second Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '28'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '.0563', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days post second infusion', 'description': 'Number of days participants were off ventilators during 28 days post second infusion.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice.'}, {'type': 'SECONDARY', 'title': 'Ventilator-Free Days Throughout 90 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '90'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}]}]}], 'analyses': [{'pValue': '.0563', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '90 days or hospital discharge, whichever is earlier', 'description': 'Number of days participants were off ventilators within up to 90 days of hospitalization.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to censoring and another subject was not included due to loss to follow-up. In the control group one subject was not included in the analysis due to discharge against medical advice.'}, {'type': 'SECONDARY', 'title': 'Respiratory Rate and Oxygenation Index (ROX Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.57', 'spread': '5.23', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ROX index was only measured for patients receiving HFNC and/or not intubated patients. Three patients were ventilated in the UC-MSC group, one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, two patients data was not collected. In the control group one subject was not included in the analysis due to death before day 6, three patients were ventilated, and one patient data was not collected.'}, {'type': 'SECONDARY', 'title': 'Oxygenation Index (OI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.62', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '12.74', 'spread': '5.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 \\* Mean airway pressure)/partial pressure of oxygen).', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Oxidation Index is only measured and calculated in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.'}, {'type': 'SECONDARY', 'title': 'Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'PEEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.73', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Plateau Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.67', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '24', 'spread': '2.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PEEP and Plateau pressure are only measured in ventilated patients, therefore 3 patients in the UC-MSC group were included and 3 patients in the control group were included.'}, {'type': 'SECONDARY', 'title': 'Sequential Organ Failure Assessment (SOFA) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.56', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.82', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': "Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to death and 2 subjects were not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.'}, {'type': 'SECONDARY', 'title': 'Smell Identification Test (SIT) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'timeFrame': '90 days', 'description': "SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell", 'reportingStatus': 'POSTED', 'populationDescription': 'No participants in the study were able to complete the Smell Evaluation Test due to extenuating circumstances related to the COVID-19 pandemic.'}, {'type': 'SECONDARY', 'title': 'White Blood Cell Count (WBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.43', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '15.53', 'spread': '5.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Platelets Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '342', 'spread': '136.33', 'groupId': 'OG000'}, {'value': '397.89', 'spread': '135.59', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Hemogoblin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.93', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '11.94', 'spread': '3.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.98', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '36.73', 'spread': '9.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'The percentage by volume of red cells in your blood as assessed via serum blood samples.', 'unitOfMeasure': 'percentage of red blood cells by volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.74', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Lymphocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Lymphocyte count as assessed via serum blood samples', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and two subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Glomerular Filtration Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.59', 'spread': '26.99', 'groupId': 'OG000'}, {'value': '68.67', 'spread': '35.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.88', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '141.22', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '141', 'spread': '9.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Sodium levels as assessed by serum blood samples.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '4.37', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Potassium levels as assessed via serum blood samples.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Creatinine levels as assessed via serum blood samples', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '153.11', 'spread': '63.99', 'groupId': 'OG000'}, {'value': '183.89', 'spread': '82.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Glucose levels as assessed via serum blood samples', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Albumin levels as assessed via serum blood samples', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '136.2', 'spread': '68.36', 'groupId': 'OG000'}, {'value': '202.5', 'spread': '219.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '38.43', 'groupId': 'OG000'}, {'value': '65.67', 'spread': '45.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'spread': '23.86', 'groupId': 'OG000'}, {'value': '47', 'spread': '32.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Total Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and 5 subjects data was not collected. In the control group one subject was not included in the analysis due to death before day 6, and 5 subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '22.28', 'groupId': 'OG000'}, {'value': '47.67', 'spread': '26.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.56', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '102.44', 'spread': '9.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'Carbon Dioxide (CO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.44', 'spread': '3.75', 'groupId': 'OG000'}, {'value': '26.44', 'spread': '4.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6, two subjects data was not collected.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.01', 'spread': '131.05', 'groupId': 'OG000'}, {'value': '112.55', 'spread': '104.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and data was missing for two subjects. In the control group one subject was not included in the analysis due to death before day 6.'}, {'type': 'SECONDARY', 'title': 'Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.6', 'spread': '12', 'groupId': 'OG000'}, {'value': '34.64', 'spread': '13.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples on day 6 (visit 8).', 'unitOfMeasure': 'ratio of AA to EPA', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.'}, {'type': 'SECONDARY', 'title': 'D-dimer Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '11.29', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '3.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.', 'unitOfMeasure': 'mcg/ml FEU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6, and one subject data was not collected. In the control group one subject was not included in the analysis due to death before day 6 and one subject data was not collected.'}, {'type': 'SECONDARY', 'title': '25-Hydroxy Vitamin D Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.21', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '27.58', 'spread': '16.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor-alpha (TNFα)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '349', 'groupId': 'OG000', 'lowerLimit': '228', 'upperLimit': '407'}, {'value': '451', 'groupId': 'OG001', 'lowerLimit': '368', 'upperLimit': '1730'}]}]}], 'analyses': [{'pValue': '0.0356', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'day 6', 'description': 'Analysis of TNFα in peripheral blood plasma', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw.'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor-beta (TNFβ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '829', 'groupId': 'OG000', 'lowerLimit': '494', 'upperLimit': '1260'}, {'value': '1540', 'groupId': 'OG001', 'lowerLimit': '852', 'upperLimit': '5890'}]}]}], 'analyses': [{'pValue': '0.0215', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'day 6', 'description': 'Analysis of TNFβ in peripheral blood plasma', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw.'}, {'type': 'SECONDARY', 'title': 'Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '26609.09', 'spread': '3071.96', 'groupId': 'OG000'}, {'value': '23111.11', 'spread': '3086.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3498', 'ciLowerLimit': '-6404.7', 'ciUpperLimit': '-591.2', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3078.2', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'day 6', 'description': 'Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC treatment group one subject was not included in the analysis due to failed intubation. In the control group one subject was not included in the analysis because of death before day 6 blood draw and data was unavailable for two patients.'}, {'type': 'SECONDARY', 'title': 'Viral Load by SARS-CoV-2 RT-PCR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2193'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 6', 'description': 'Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).', 'unitOfMeasure': 'RNA copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The UC-MSC treatment group one subject was not included in the analysis due to death, one subject was not included due to discharge on day 6. In the control group one subject was not included in the analysis due to death before day 6.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Class I', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Class II', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 3 days post first infusion".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (class II) status and treatment group at 3 days post first infusion."', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 3 post first infusion', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the control group died before day 3 post first infusion.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Class I', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Class II', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 6 days post first infusion".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (Class II) status and treatment group at 6 days post first infusion".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 6', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC group one patient was censored and died before day 6 and one patient recovered before day 6 and left the hospital. In the control group on patient died before day 6 post first infusion.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'Class I', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Class II', 'categories': [{'title': 'PRA Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'PRA Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (class I) status and treatment group at 14 days post first infusion".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5238', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The null hypothesis is the following: "There is no association between PRA (class II) status and treatment group at 14 days post first infusion".', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In the UC-MSC group one patient was censored and died before day 6, 6 patients left the hospital before day 6 post first infusion. In the control group 4 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'classes': [{'title': 'IgM', 'categories': [{'title': 'Positive', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Negative', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Borderline', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'IgG', 'categories': [{'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Negative', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Borderline', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 14 post first infusion', 'description': 'Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'These analyses were implemented in a protocol version that did not apply to 2 patients of the UC-MSC treatment group and 3 patients of the control group. In the UC-MSC group one patient was censored and died before day 6, 4 patients left the hospital before day 6 post first infusion and in one patient blood was not drawn. In the control group 3 patients died, 3 patients left the hospital and one left hospital against medical advice before day 6 post first infusion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nUmbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.: UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.\n\nVehicle + Heparin along with best supportive care: Best supportive care treatment per the treating hospital protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.58', 'spread': '15.93', 'groupId': 'BG000'}, {'value': '58.83', 'spread': '11.61', 'groupId': 'BG001'}, {'value': '58.71', 'spread': '13.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemogoblin from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.93', 'spread': '2.04', 'groupId': 'BG000'}, {'value': '12.45', 'spread': '2.35', 'groupId': 'BG001'}, {'value': '12.69', 'spread': '2.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematocrit from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.71', 'spread': '6.53', 'groupId': 'BG000'}, {'value': '40.76', 'spread': '5.08', 'groupId': 'BG001'}, {'value': '40.18', 'spread': '5.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total blood volume', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. CBC with differential at baseline was not done in a subset of patients.'}, {'title': 'White Blood Count (WBC) from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.87', 'spread': '5.26', 'groupId': 'BG000'}, {'value': '14.17', 'spread': '5.45', 'groupId': 'BG001'}, {'value': '13.02', 'spread': '5.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neutrophils from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.25', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '13.37', 'spread': '5.33', 'groupId': 'BG001'}, {'value': '11.21', 'spread': '5.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. CBC with differential at baseline was not done in a subset of patients.'}, {'title': 'Lymphocytes from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '0.72', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '0.95', 'spread': '0.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. CBC with differential at baseline was not done in a subset of patients.'}, {'title': 'Platelet count from Complete Blood Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '329.83', 'spread': '99.52', 'groupId': 'BG000'}, {'value': '342.58', 'spread': '91.83', 'groupId': 'BG001'}, {'value': '336.21', 'spread': '93.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '10^3 cells/uL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glomerular Filtration Rate from Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '31.61', 'groupId': 'BG000'}, {'value': '61.25', 'spread': '37.59', 'groupId': 'BG001'}, {'value': '67.88', 'spread': '34.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Protein from Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.39', 'spread': '0.69', 'groupId': 'BG000'}, {'value': '6.45', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '6.42', 'spread': '0.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Sodium for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '138.92', 'spread': '3.15', 'groupId': 'BG000'}, {'value': '136.58', 'spread': '5.04', 'groupId': 'BG001'}, {'value': '137.75', 'spread': '4.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Potassium for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.37', 'spread': '0.55', 'groupId': 'BG000'}, {'value': '4.52', 'spread': '0.67', 'groupId': 'BG001'}, {'value': '4.44', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Creatine for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '1.92', 'spread': '1.88', 'groupId': 'BG001'}, {'value': '1.55', 'spread': '1.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glucose for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '190.75', 'spread': '107.14', 'groupId': 'BG000'}, {'value': '193.67', 'spread': '85.44', 'groupId': 'BG001'}, {'value': '192.21', 'spread': '94.78', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Albumin for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.22', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '3.21', 'spread': '0.51', 'groupId': 'BG001'}, {'value': '3.22', 'spread': '0.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Alkaline Phosphatase for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '90.9', 'spread': '59.3', 'groupId': 'BG000'}, {'value': '96.5', 'spread': '52.69', 'groupId': 'BG001'}, {'value': '93.7', 'spread': '54.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Alanine Aminotransferase (ALT) or Serum Glutamic-pyruvic Transaminase (SGPT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.1', 'spread': '51.19', 'groupId': 'BG000'}, {'value': '82.45', 'spread': '75.18', 'groupId': 'BG001'}, {'value': '77.52', 'spread': '63.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Alanine Aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT) for comprehensive metabolic panel as assessed from serum blood samples.', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'spread': '31.07', 'groupId': 'BG000'}, {'value': '118.45', 'spread': '153.16', 'groupId': 'BG001'}, {'value': '88.62', 'spread': '114.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Aspartate Aminotransferase (AST) or Serum Glutamic-Oxaloacetic Transaminase (SGOT) for the comprehensive metabolic panel assessed from serum blood samples.', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Total Bilirubin for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '0.65', 'spread': '0.25', 'groupId': 'BG001'}, {'value': '0.64', 'spread': '0.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Comprehensive metabolic panel was not completed (only basal metabolic panel) in some patients.'}, {'title': 'Blood Urea Nitrogen (BUN) for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.58', 'spread': '16.61', 'groupId': 'BG000'}, {'value': '42.67', 'spread': '31.27', 'groupId': 'BG001'}, {'value': '36.13', 'spread': '25.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calcium for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.53', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '8.32', 'spread': '0.87', 'groupId': 'BG001'}, {'value': '8.43', 'spread': '0.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chloride Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '4.29', 'groupId': 'BG000'}, {'value': '100.5', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '100.75', 'spread': '5.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Carbon Dioxide (CO2) for Comprehensive Metabolic Panel', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.42', 'spread': '3.99', 'groupId': 'BG000'}, {'value': '21.92', 'spread': '4.62', 'groupId': 'BG001'}, {'value': '23.17', 'spread': '4.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Oxygenation Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.09', 'spread': '2.63', 'groupId': 'BG000'}, {'value': '14.32', 'spread': '14.68', 'groupId': 'BG001'}, {'value': '11.83', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 \\* Mean airway pressure)/partial pressure of oxygen).', 'unitOfMeasure': 'Index', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Oxidation Index is only measured and calculated in ventilated patients.'}, {'title': 'Positive End-Expiratory Pressure (PEEP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.75', 'spread': '2.06', 'groupId': 'BG000'}, {'value': '12.71', 'spread': '2.14', 'groupId': 'BG001'}, {'value': '13.09', 'spread': '2.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. PEEP is only measured in patients on ventilator.'}, {'title': 'Plateau Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13.75', 'spread': '9.74', 'groupId': 'BG000'}, {'value': '29', 'spread': '7.39', 'groupId': 'BG001'}, {'value': '21.38', 'spread': '11.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Plateau pressure as assessed for patients on a ventilator', 'unitOfMeasure': 'cm H2O', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing. Plateau Pressure is only measured in patients on ventilator.'}, {'title': 'Sequential Organ Failure Assessment (SOFA) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.61', 'groupId': 'BG000'}, {'value': '7.64', 'spread': '3.35', 'groupId': 'BG001'}, {'value': '6.52', 'spread': '3.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). Totaling a maximum SOFA score of 24 and minimum of 0.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data missing.'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97.97', 'spread': '77.56', 'groupId': 'BG000'}, {'value': '144.35', 'spread': '115.69', 'groupId': 'BG001'}, {'value': '121.16', 'spread': '99.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'D-Dimer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '2.35', 'groupId': 'BG000'}, {'value': '4.96', 'spread': '6.04', 'groupId': 'BG001'}, {'value': '3.29', 'spread': '4.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'D-dimer as assessed from serum blood samples.', 'unitOfMeasure': 'mcg/mL FEU', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'data missing. Collected in a tube that has been recalled by the manufacturer so test was canceled by Quest'}, {'title': 'Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45.38', 'spread': '24.89', 'groupId': 'BG000'}, {'value': '45.79', 'spread': '23.93', 'groupId': 'BG001'}, {'value': '45.58', 'spread': '23.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'ratio of AA to EPA as assessed via serum blood samples.', 'unitOfMeasure': 'ratio of AA to EPA', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': '25-OH vitamin D levels', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.76', 'spread': '8.48', 'groupId': 'BG000'}, {'value': '23.19', 'spread': '12.85', 'groupId': 'BG001'}, {'value': '22.47', 'spread': '10.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory Rate and Oxygenation Index (ROX)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.36', 'spread': '7.73', 'groupId': 'BG000'}, {'value': '3.59', 'spread': '1.13', 'groupId': 'BG001'}, {'value': '5.91', 'spread': '6.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ROX index is the measure of the ratio of pulse oximetry/fraction of inspired oxygen (SpO2/FiO2) to respiratory rate (RR). The ROX index is used as a predictor of the need to intubate in patients receiving HFNC oxygen therapy; performed at 2, 6 and 12 hours. ROX at 2, 6 and 12 hours after HFNC initiation was associated with a lower risk for intubation. For a ROX Index \\<3.85, risk of HFNC failure is high. If ROX Index 3.85 to \\<4.88, the scoring could be repeated one or two hours later for further evaluation.', 'unitOfMeasure': 'Index', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'data missing. Some patients were on a ventilator. Patients only on HFNC have ROX scores.'}, {'title': 'Viral Load by SARS-CoV-2 RT-PCR', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '352', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '2184.5'}, {'value': '3570.50', 'groupId': 'BG001', 'lowerLimit': '175', 'upperLimit': '18408.50'}, {'value': '710', 'groupId': 'BG002', 'lowerLimit': '114', 'upperLimit': '10799.50'}]}]}], 'paramType': 'MEDIAN', 'description': 'Viral load as assessed in blood plasma for SARS-CoV-2', 'unitOfMeasure': 'copies', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Panel Reactive Antibody (PRA)', 'classes': [{'title': 'PRA Results Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive PRA', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Negative PRA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'PRA Results Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive PRA', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Negative PRA', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Panel Reactive Antibody (PRA) for Class I and Class II assessed via serum blood samples', 'unitOfMeasure': 'Participants'}, {'title': 'Serology (anti-SARS-CoV-2 IgM and IgG)', 'classes': [{'title': 'IgM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Borderline', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Positive', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Borderline', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Serology (anti-SARS-CoV-2 IgM and IgG) analyzed in blood serum samples.', 'unitOfMeasure': 'Participants', 'populationDescription': 'These analyses were implemented in a protocol version that did not apply to two patients of the UC-MSC treatment group and three patients of the control group.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-12', 'size': 11077243, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-14T11:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blinding Trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The trial has two groups, each with 12 subjects (n=24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2020-04-13', 'resultsFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-01', 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Pre-Specified Infusion Associated Adverse Events', 'timeFrame': '6 and 24 hours', 'description': 'Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:\n\n1. An increase in vasopressor dose greater than or equal to the following:\n\n * Norepinephrine: 10 μg/min\n * Phenylephrine: 100 μg/min\n * Dopamine: 10 μg/kg/min\n * Epinephrine: 10 μg/min\n2. In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of \\>20%.\n3. In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.\n4. New cardiac arrhythmia requiring cardioversion\n5. New ventricular tachycardia, ventricular fibrillation, or asystole\n6. A clinical scenario consistent with transfusion incompatibility or transfusion-related infection\n7. Cardiac arrest or death within 24h post infusion'}, {'measure': 'Number of Subjects With Serious Adverse Events by 31 Days After First Infusion', 'timeFrame': '31 days', 'description': 'The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).'}, {'measure': 'Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90', 'timeFrame': '90 days', 'description': 'Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.'}, {'measure': 'Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': '90 days', 'description': 'Total number of adverse events and serious adverse events as assessed by treating physician'}, {'measure': 'Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity', 'timeFrame': '90 days', 'description': 'Total number of adverse events plus serious adverse events categorized by severity.'}, {'measure': 'Subjects With Adverse Events and Serious Adverse Events by Severity', 'timeFrame': '90 days', 'description': 'Total number of subjects with adverse events and serious adverse events categorized by severity.'}, {'measure': 'Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment', 'timeFrame': '90 days', 'description': 'Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.'}, {'measure': 'Subjects With Adverse Events by Relatedness to Treatment', 'timeFrame': '90 days', 'description': 'Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional'}], 'secondaryOutcomes': [{'measure': 'Survival at 31 Days Post First Infusion', 'timeFrame': '31 Days', 'description': 'Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.'}, {'measure': 'Survival at 60 Days Post First Infusion', 'timeFrame': '60 days', 'description': 'Number of participants alive at 60 days post first infusion follow up.'}, {'measure': 'Time to Recovery', 'timeFrame': '31 days', 'description': 'Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.'}, {'measure': 'Ventilator-Free Days Throughout 28 Days Post Second Infusion', 'timeFrame': '28 days post second infusion', 'description': 'Number of days participants were off ventilators during 28 days post second infusion.'}, {'measure': 'Ventilator-Free Days Throughout 90 Days', 'timeFrame': '90 days or hospital discharge, whichever is earlier', 'description': 'Number of days participants were off ventilators within up to 90 days of hospitalization.'}, {'measure': 'Respiratory Rate and Oxygenation Index (ROX Index)', 'timeFrame': 'day 6', 'description': 'Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.'}, {'measure': 'Oxygenation Index (OI)', 'timeFrame': 'day 6', 'description': 'Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 \\* Mean airway pressure)/partial pressure of oxygen).'}, {'measure': 'Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)', 'timeFrame': 'day 6', 'description': 'Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)'}, {'measure': 'Sequential Organ Failure Assessment (SOFA) Scores', 'timeFrame': 'Day 6', 'description': "Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure)."}, {'measure': 'Smell Identification Test (SIT) Scores', 'timeFrame': '90 days', 'description': "SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell"}, {'measure': 'White Blood Cell Count (WBC)', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.'}, {'measure': 'Platelets Count', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.'}, {'measure': 'Hemogoblin', 'timeFrame': 'day 6', 'description': 'Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.'}, {'measure': 'Hematocrit', 'timeFrame': 'day 6', 'description': 'The percentage by volume of red cells in your blood as assessed via serum blood samples.'}, {'measure': 'Neutrophils', 'timeFrame': 'day 6', 'description': 'the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples'}, {'measure': 'Lymphocytes', 'timeFrame': 'day 6', 'description': 'Lymphocyte count as assessed via serum blood samples'}, {'measure': 'Glomerular Filtration Rate', 'timeFrame': 'day 6', 'description': 'Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.'}, {'measure': 'Total Protein', 'timeFrame': 'Day 6', 'description': 'Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.'}, {'measure': 'Sodium', 'timeFrame': 'day 6', 'description': 'Sodium levels as assessed by serum blood samples.'}, {'measure': 'Potassium', 'timeFrame': 'day 6', 'description': 'Potassium levels as assessed via serum blood samples.'}, {'measure': 'Creatinine', 'timeFrame': 'day 6', 'description': 'Creatinine levels as assessed via serum blood samples'}, {'measure': 'Glucose', 'timeFrame': 'day 6', 'description': 'Glucose levels as assessed via serum blood samples'}, {'measure': 'Albumin', 'timeFrame': 'day 6', 'description': 'Albumin levels as assessed via serum blood samples'}, {'measure': 'Alkaline Phosphatase', 'timeFrame': 'day 6', 'description': 'Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.'}, {'measure': 'Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)', 'timeFrame': 'day 6', 'description': 'The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples'}, {'measure': 'Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)', 'timeFrame': 'day 6', 'description': 'The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples'}, {'measure': 'Total Bilirubin', 'timeFrame': 'day 6', 'description': 'Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.'}, {'measure': 'Blood Urea Nitrogen (BUN)', 'timeFrame': 'day 6', 'description': 'Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.'}, {'measure': 'Calcium', 'timeFrame': 'day 6', 'description': 'Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.'}, {'measure': 'Chloride', 'timeFrame': 'day 6', 'description': 'Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.'}, {'measure': 'Carbon Dioxide (CO2)', 'timeFrame': 'day 6', 'description': 'Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.'}, {'measure': 'C-Reactive Protein Levels', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.'}, {'measure': 'Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples on day 6 (visit 8).'}, {'measure': 'D-dimer Levels', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.'}, {'measure': '25-Hydroxy Vitamin D Levels', 'timeFrame': 'day 6', 'description': 'As assessed via serum blood samples.'}, {'measure': 'Tumor Necrosis Factor-alpha (TNFα)', 'timeFrame': 'day 6', 'description': 'Analysis of TNFα in peripheral blood plasma'}, {'measure': 'Tumor Necrosis Factor-beta (TNFβ)', 'timeFrame': 'day 6', 'description': 'Analysis of TNFβ in peripheral blood plasma'}, {'measure': 'Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)', 'timeFrame': 'day 6', 'description': 'Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma'}, {'measure': 'Viral Load by SARS-CoV-2 RT-PCR', 'timeFrame': 'day 6', 'description': 'Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).'}, {'measure': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion', 'timeFrame': 'day 3 post first infusion', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.'}, {'measure': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion', 'timeFrame': 'day 6', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.'}, {'measure': 'Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion', 'timeFrame': 'day 14', 'description': 'Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.'}, {'measure': 'Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG', 'timeFrame': 'day 14 post first infusion', 'description': 'Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['Corona Virus Infection', 'ARDS', 'ARDS, Human', 'Acute Respiratory Distress Syndrome', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients \\>/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:\n\n1. Patient currently hospitalized\n2. Aged ≥ 18 years\n3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent\n4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening\n5. PaO2/FiO2 ratio \\< 300 mmHg\n6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan\n7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation\n\nExclusion Criteria:\n\n1. PaO2/FiO2 ≥ 300 at the time of enrollment\n2. A previous MSC infusion not related to this trial\n3. History of Pulmonary Hypertension (WHO Class III/IV)\n4. History of left atrial hypertension or decompensated left heart failure.\n5. Pregnant or lactating patient\n6. Unstable arrhythmia\n7. Patients with previous lung transplant\n8. Patients currently receiving chronic dialysis\n9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)\n10. Presence of any active malignancy (except non-melanoma skin cancer)\n11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%\n12. Moderate to severe liver disease (AST and ALT \\>5 X ULN)\n13. Severe chronic respiratory disease with a PaCO2 \\> 50 mm Hg or the use of home oxygen\n14. Baseline QT prolongation\n15. Moribund patient not expected to survive \\> 24 hours'}, 'identificationModule': {'nctId': 'NCT04355728', 'briefTitle': 'Use of UC-MSCs for COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)', 'orgStudyIdInfo': {'id': '20200671'}, 'secondaryIdInfos': [{'id': '20200370', 'type': 'OTHER', 'domain': 'Secondary Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UC-MSCs Group', 'description': 'Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.', 'interventionNames': ['Biological: Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.', 'interventionNames': ['Other: Vehicle + Heparin along with best supportive care']}], 'interventions': [{'name': 'Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.', 'type': 'BIOLOGICAL', 'description': 'UC-MSC will be administered at 100x10\\^6 cells/infusion administered intravenously in addition to the standard of care treatment.', 'armGroupLabels': ['UC-MSCs Group']}, {'name': 'Vehicle + Heparin along with best supportive care', 'type': 'OTHER', 'description': 'Best supportive care treatment per the treating hospital protocol.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Diabetes Research Institute, University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Camillo Ricordi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Camillo Ricordi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Chief, Division of Cellular Transplantation', 'investigatorFullName': 'Camillo Ricordi', 'investigatorAffiliation': 'University of Miami'}}}}