Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT04343651
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C420063', 'term': 'leronlimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'skelly@cytodyn.com', 'phone': '(360) 980-8524', 'title': 'Dr. Scott Kelly, Chief Medical Officer', 'organization': 'CytoDyn Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Study drug was administered at Visit 2 (day 0) and visit 4 (day 7). Adverse events were assessed during the course of treatment and during the follow up period i.e., 2 weeks (visit 6) and 4 weeks (visit 7) after end of treatment. Therefore adverse events were assessed over a period of 5 weeks (visit 2 to visit 7).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebos: Placebo\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 12, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': '700mg Leronlimab', 'description': 'Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 7, 'seriousNumAtRisk': 56, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA 23.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Liver Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Total Symptom Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebos: Placebo\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '3.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.818', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Clinical Improvement will be assessed at baseline and at EOT (day 14).', 'description': 'Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened.\n\nNote: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \\[0=none, 1=mild, 2=moderate, and 3=severe\\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat (mITT) population was defined as the set of subjects who received at least one dose of leronlimab (PRO 140) or placebo. This population was to be used for the analysis of efficacy parameters or measurements. At the time of this report, there were 84 subjects in the mITT population.'}, {'type': 'SECONDARY', 'title': 'Time to Clinical Resolution (TTCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': '25% subjects', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '50% subjects', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '75% subjects', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.781', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.41', 'statisticalMethod': 'Likelihood test-Cox Prop. hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratification factors: Baseline NEWS Total score and Age.'}], 'paramType': 'NUMBER', 'timeFrame': 'Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).', 'description': 'Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough).\n\nData presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab.\n\nThe hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138.\n\nTTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0.', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Incidence of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '1 time', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '2 times', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From visit 2 (day 0) through day 14 (in days)', 'description': 'Number of patients requiring hospitalization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Duration (Days) of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Total duration of hospitalization between visit 2 (day 0) in days and end of treatment', 'description': 'Duration of hospitalization in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Incidence of Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': '1 Time', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Total duration of mechanical ventilation since visit 2 (day 0) (days)', 'description': 'Incidence of mechanical ventilation supply', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Duration of Mechanical Ventilation Supply', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of mechanical ventilation since visit 2 (day 0) (days', 'description': 'Duration (days) of mechanical ventilation supply', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Incidence of Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'One time', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Two times', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Three times', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Use of oxygen since visit 2 (day 0) to end of treatment', 'description': 'Incidence of oxygen use over course of treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Duration of Oxygen Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)', 'description': 'Duration of oxygen use in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Mortality at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mortality at EOT (day 14)', 'description': 'Incidence of mortality at day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Time to Return to Normal Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': '25th percentile pts return to normal', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': '50th percentile pts return to normal', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}, {'title': '75th percentile pts return to normal', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"', 'description': 'Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': 'Change from Baseline to Day 3', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.67', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 7', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Day 14', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 3, 7 and 14', 'description': 'NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring.\n\nChange shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebos: Placebo\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}], 'classes': [{'title': 'Mean change from Baseline to Day 3 of percent oxygen saturation', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Mean change from Baseline to Day 7 of percent oxygen saturation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'Mean change from Baseline to Day 14 of percent oxygen saturation', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14', 'description': 'Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values', 'unitOfMeasure': 'Mean change in % O2 sat', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14", 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.\n\nLeronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)'}], 'classes': [{'title': 'Mean change from baseline at day 3', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Mean change from baseline at day 7', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.99', 'groupId': 'OG001'}]}]}, {'title': 'Mean change from baseline at day 14', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14)', 'description': 'A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.\n\nLower scores mean a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Size of Lesion Area by Chest Radiograph or CT', 'timeFrame': 'Day 14', 'description': 'Change in size of lesion area by chest radiograph or CT - exploratory endpoint', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Serum Cytokine and Chemokine Levels', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebos: Placebo\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}, {'id': 'FG001', 'title': '700mg Leronlimab', 'description': 'Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not start treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient did not complete visits 3-6', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the United States. The first participant was randomized on 30-Apr-2020. Data submitted represent analysis performed on data collected after all patients completed the Follow UP period.', 'preAssignmentDetails': '126 patients were screened, 40 were screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebos: Placebo\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}, {'id': 'BG001', 'title': '700mg Leronlimab', 'description': 'Leronlimab (700mg): Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)\n\nPatients who meet the below criteria will be randomized 2:1 to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nMale or female adult ≥ 18 years of age at time of enrollment with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\nMild (uncomplicated) Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n* No signs of a more serious lower airway disease AND\n* RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\nModerate Illness:\n\n* Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n* In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n* Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n* If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n\nClinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '21', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.36', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '84'}, {'value': '54.59', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '79'}, {'value': '54.85', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'COVID SYMPTOMS SCORE', 'classes': [{'categories': [{'title': 'Baseline symptom score less than or equal to 4', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Baseline symptom score greater than 4', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline symptoms assessed were fever, myalgia, dyspnea, and cough. Each symptom was graded from 0 to 3 \\[0=none, 1=mild, 2=moderate, and 3=severe\\]. The total score is calculated by summing all scores, with a higher score indicating a worse health state.\n\nThe total score per patient ranged from 0 to 12 points.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of leronlimab or placebo and is population used for the analysis of efficacy parameters or measurements.\n\nThe Safety Population includes all subjects who received at least one dose of leronlimab or placebo. This population was used for the analysis of safety parameters or measurements. There were 84 subjects in the MITT and Safety Population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-30', 'size': 1124842, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-20T10:24', 'hasProtocol': True}, {'date': '2020-04-26', 'size': 975037, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-20T10:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2020-03-31', 'resultsFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-08', 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Size of Lesion Area by Chest Radiograph or CT', 'timeFrame': 'Day 14', 'description': 'Change in size of lesion area by chest radiograph or CT - exploratory endpoint'}, {'measure': 'Change From Baseline in Serum Cytokine and Chemokine Levels', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in serum cytokine and chemokine levels at day 3, day 7 and day 14'}, {'measure': 'Change From Baseline in CCR5 Receptor Occupancy Levels for Tregs and Macrophages', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages at day3, day 7 and day 14'}, {'measure': 'Change From Baseline in CD3+, CD4+ and CD8+ T Cell Count', 'timeFrame': 'Days 3, 7, and 14', 'description': 'Change from baseline in CD3+, CD4+ and CD8+ T cell count at day 3, day 7 and day 14'}], 'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Symptom Score', 'timeFrame': 'Clinical Improvement will be assessed at baseline and at EOT (day 14).', 'description': 'Clinical Improvement as assessed by change in total symptom score (for fever, myalgia, dyspnea and cough) by count of patients showing improvement, no change or worsened.\n\nNote: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3. \\[0=none, 1=mild, 2=moderate, and 3=severe\\]. Higher scores mean a worse outcome. A negative change from baseline shows an improvement in symptom score.'}], 'secondaryOutcomes': [{'measure': 'Time to Clinical Resolution (TTCR)', 'timeFrame': 'Time (in days) from initiation of study treatment until resolution of clinical symptoms (fever, myalgia, dyspnea and cough).', 'description': 'Defined as the time from initiation of study treatment to the resolution of clinical symptoms (fever, myalgia, dyspnea, cough).\n\nData presented how the number of days at which a certain percentage of patients achieve resolution of symptoms, i.e., 50% of patients on placebo saw resolution of symptoms in 15 days, and 15 days for patients on leronlimab.\n\nThe hazard ratio was 0.781, 95% Confidence Interval 0.43, 1.41 and the p-value was 0.4138.\n\nTTCR is defined as the duration from date of first exposure to treatment to the first occurrence of total symptom score equals 0.'}, {'measure': 'Incidence of Hospitalization', 'timeFrame': 'From visit 2 (day 0) through day 14 (in days)', 'description': 'Number of patients requiring hospitalization'}, {'measure': 'Duration (Days) of Hospitalization', 'timeFrame': 'Total duration of hospitalization between visit 2 (day 0) in days and end of treatment', 'description': 'Duration of hospitalization in days'}, {'measure': 'Incidence of Mechanical Ventilation', 'timeFrame': 'Total duration of mechanical ventilation since visit 2 (day 0) (days)', 'description': 'Incidence of mechanical ventilation supply'}, {'measure': 'Duration of Mechanical Ventilation Supply', 'timeFrame': 'Duration of mechanical ventilation since visit 2 (day 0) (days', 'description': 'Duration (days) of mechanical ventilation supply'}, {'measure': 'Incidence of Oxygen Use', 'timeFrame': 'Use of oxygen since visit 2 (day 0) to end of treatment', 'description': 'Incidence of oxygen use over course of treatment'}, {'measure': 'Duration of Oxygen Use', 'timeFrame': 'Total duration of oxygen use since visit 2 (day 0) to EOT (day 14) (days)', 'description': 'Duration of oxygen use in days'}, {'measure': 'Mortality at Day 14', 'timeFrame': 'Mortality at EOT (day 14)', 'description': 'Incidence of mortality at day 14'}, {'measure': 'Time to Return to Normal Activity', 'timeFrame': 'Date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"', 'description': 'Time to return to normal activity from initiation of study treatment defined as duration from date of first exposure to treatment to the first occurrence of ordinal scale equals "not hospitalized, no limitations of activities"'}, {'measure': 'Change From Baseline in National Early Warning Score 2 (NEWS2) to Day 3, 7 and 14', 'timeFrame': 'Baseline to Day 3, 7 and 14', 'description': 'NEWS2 is an assessment based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness) developed by the Royal College of Physicians (https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2). Respiratory rate (bpm) scores 0-3; Sp02 (on room air or suppl) scores 0-3; SpO2 (hypercapnic resp failure) scores 0-3; room air or supplemental O2 scores 0 (room) or 2 (suppl); temperature - scores 0-3; systolic BP scores 0-3; pulse (bpm) scores 0-3; consciousness - alert (score 0) vs. new onset confusion (score 3). The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring.\n\nChange shown is positive or negative from baseline, with a negative number indicating improvement (i.e., a decrease in total score).'}, {'measure': 'Mean Change in Percent Oxygen Saturation From Baseline to Days 3, 7 and 14', 'timeFrame': 'Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14', 'description': 'Mean change in percent oxygen saturation from baseline to Days 3, 7 and 14 for patients with paired values'}, {'measure': "Change From Baseline in the Patient's Health Status on a 7-category Ordinal Scale on Days 3, 7 and 14", 'timeFrame': 'Assessments performed Day 0 (first treatment is Visit 2, day 0), Visit 3 (3+/- 1 day after first treatment) Visit 4 (second treatment, 7+/- 1 day from V2, day7) and end of treatment (7+/- 1 day from V4, day 14)', 'description': 'A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.\n\nLower scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['Coronavirus Disease 2019']}, 'referencesModule': {'references': [{'pmid': '39353749', 'type': 'DERIVED', 'citation': 'Seethamraju H, Yang OO, Loftus R, Ogbuagu O, Sammartino D, Mansour A, Sacha JB, Ojha S, Hansen SG, Arman AC, Lalezari JP. A Randomized Placebo-Controlled Trial of Leronlimab in Mild-To-Moderate COVID-19. Clin Ther. 2024 Nov;46(11):891-899. doi: 10.1016/j.clinthera.2024.08.019. Epub 2024 Sep 30.'}], 'seeAlsoLinks': [{'url': 'https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2', 'label': 'NEWS2 Score'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.', 'detailedDescription': 'This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.\n\nThe study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.\n\nA total of 75 subjects will be randomized 2:1 in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female adult ≥ 18 years of age at time of enrollment.\n2. Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection as defined below:\n\n Mild (uncomplicated) Illness:\n * Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n * Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND\n * No signs of a more serious lower airway disease AND\n * RR\\<20, HR \\<90, oxygen saturation (pulse oximetry) \\> 93% on room air\n\n Moderate Illness:\n * Diagnosed with COVID-19 by a standardized RT-PCR assay AND\n * In addition to symptoms above, more significant lower respiratory symptoms, including shortness of breath (at rest or with exertion) OR\n * Signs of moderate pneumonia, including RR ≥ 20 but \\<30, HR ≥ 90 but less than 125, oxygen saturation (pulse oximetry) \\> 93% on room air AND\n * If available, lung infiltrates based on X-ray or CT scan \\< 50% present\n3. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.\n4. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.\n5. Understands and agrees to comply with planned study procedures.\n6. Women of childbearing potential must agree to use at least one medically accepted method of contraception (e.g., barrier contraceptives \\[condom, or diaphragm with a spermicidal gel\\], hormonal contraceptives \\[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\\], or intrauterine devices) for the duration of the study.\n\nExclusion Criteria:\n\n1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening;\n2. History of severe chronic respiratory disease and requirement for long-term oxygen therapy;\n3. Subjects showing signs of clinical jaundice at the time of screening;\n4. History of moderate and severe liver disease (Child-Pugh score \\>12);\n5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening;\n6. History of severe chronic kidney disease or requiring dialysis;\n7. Any uncontrolled active systemic infection requiring admission to an intensive care unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C virus will be eligible for the study if they have no signs of hepatic decompensation.\n\n Note: Subjects infected with HIV-1 will be eligible for the study with undetectable viral load and are on a stable ART regimen. Investigators are required to review the subjects' medical records to confirm HIV-1 RNA suppression within the previous 3 months.\n\n Note: Empirical antibiotic treatment for secondary bacterial infections is allowed during the course of study.\n8. Patients with malignant tumor, or other serious systemic diseases;\n9. Patients who are participating in other clinical trials;\n10. Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible; and\n11. Inability to provide informed consent or to comply with test requirements"}, 'identificationModule': {'nctId': 'NCT04343651', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19', 'organization': {'class': 'INDUSTRY', 'fullName': 'CytoDyn, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)', 'orgStudyIdInfo': {'id': 'CD10_COVID-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo comparator consists of the formulation buffer for leronlimab, i.e., the placebo is the same as the active arm without leronimab. The placebo is presented in the same container closure at the same fill volume as the active (nominal 1mL fill volume). The formulation buffer contains histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '700mg Leronlimab', 'description': 'Each vial of active contains 175mg of leronlimab at a concentration of 175mg/ml (nominal 1mL fill volume) in formulation buffer containing histidine, glycine, sodium chloride, sorbitol, polysorbate 20 and sterile water for injections.', 'interventionNames': ['Drug: Leronlimab (700mg)']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}, {'name': 'Leronlimab (700mg)', 'type': 'DRUG', 'otherNames': ['PRO 140'], 'description': 'Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)', 'armGroupLabels': ['700mg Leronlimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262-4871', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Palmtree Clinical Research, Inc.', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Eisenhower Health', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Center for Advanced Research & Education (CARE)', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '07962-1905', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10601', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'White Plains Hospital', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '27103', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Angela Ritter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Advanced Research and Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CytoDyn, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}