Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04542967
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2020-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The research was blinded as possible for the result's evaluators and those responsible for the statistical analysis. All patients admitted to the investigation were placed with a marker indicating that they were a patient of the plasma protocol, but not mention the study group. The data collectors and the outcome adjudicators were unaware of the treatment assignments."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2020-09-04', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory biomarkers (D dimer)', 'timeFrame': '10 days', 'description': 'Change in pro-inflammatory biomarkers (D dimer μg/l)'}, {'measure': 'Inflammatory biomarkers (Ferritin)', 'timeFrame': '10 days', 'description': 'Change in pro-inflammatory biomarkers ( Ferritin μg/L )'}, {'measure': 'Inflammatory biomarkers (CPR)', 'timeFrame': '10 days', 'description': 'Change in pro-inflammatory biomarkers, C-reactive protein ( CPR mg/L )'}, {'measure': 'Inflammatory biomarkers (LDH)', 'timeFrame': '10 days', 'description': 'Change in pro-inflammatory biomarkers, lactate dehydrogenase ( LDH UI/L)'}], 'primaryOutcomes': [{'measure': 'Disease progression', 'timeFrame': 'Up to 30 days later from study entry', 'description': 'Change in ordinal Scale for Clinical Improvement (WHO). The progression disease, its the change in the severity score; a bigger number to the obtained after randomization'}, {'measure': 'Side effects', 'timeFrame': 'Up to 30 days later from study entry', 'description': 'Side effects associated with the administration of convalescent plasma'}, {'measure': 'Mortality', 'timeFrame': 'Up to 30 days later from study entry', 'description': 'Any cause of death'}], 'secondaryOutcomes': [{'measure': 'Respiratory improvement', 'timeFrame': '10 days', 'description': 'Change in partial pressure of arterial Oxygen to Fraction of inspired Oxygen ratio (PaO2/FiO2)'}, {'measure': 'Clinical improvement', 'timeFrame': '10 days', 'description': 'Change in oxygen saturation levels'}, {'measure': 'Acute adverse events (AAE)', 'timeFrame': 'After receiving intervention, an average time one hour, until 24 hours after administration.', 'description': 'Transfusion reactions during transfusion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV2', 'Convalescent Plasma', 'Severe Acute Respiratory Syndrome'], 'conditions': ['Severe COVID-19 Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/32109013/', 'label': 'Clinical Characteristics of Coronavirus Disease 2019 in China'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/32052466/', 'label': 'Potential interventions for novel coronavirus in China: A systematic review'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/15616839/', 'label': 'Use of convalescent plasma therapy in SARS patients in Hong Kong'}]}, 'descriptionModule': {'briefSummary': 'Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are being investigated as treatment, but the effect is unknown. A strategy and other method used before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of immune (convalescent) plasma. Passive administration of antibodies through convalescent plasma transfusion may offer the only short-term strategy available to confer immediate immunity and being a relative immediately resource available for treat COVID-19 disease. This research proposes the passive administration of antibodies through the transfusion of convalescent plasma, in patients with severe COVID-19 disease.', 'detailedDescription': 'A randomized clinical trial comparing administration convalescent plasma to standard therapy for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Our primary outcomes will be disease progression and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* O2 saturation \\<93%\n* Radiographic evidence of moderate pneumonia according to Rale's classification.\n* Acute respiratory distress syndrome (PaO2 / FiO2 \\<300 or SpO2 / FiO2 ≤ 315)\n* Authorization to participate in the study and have informed consent letter, signed by the patient or the person responsible for the patient in case of critical patients (intubated)\n\nExclusion Criteria:\n\n* Pregnant patients\n* History of transfusion reactions\n* Patients with congestive heart failure\n* Patients with a history of chronic kidney failure on dialysis\n* Patients with multiple organ failure\n* Patients who does not accept or agree with the treatment."}, 'identificationModule': {'nctId': 'NCT04542967', 'acronym': 'PC-COVID-HCM', 'briefTitle': 'Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Central Militar'}, 'officialTitle': 'Convalescent Plasma as a Treatment for Patients With Severe COVID-19 Disease', 'orgStudyIdInfo': {'id': '047/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'They will receive the standard care for critically ill inpatients.'}, {'type': 'EXPERIMENTAL', 'label': 'Convalescent plasma group.', 'description': 'They will receive standard care for patients with severe COVID-19 disease and convalescent plasma disease.', 'interventionNames': ['Biological: Biological']}], 'interventions': [{'name': 'Biological', 'type': 'BIOLOGICAL', 'otherNames': ['Convalescent plasma'], 'description': 'An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.\n\nIf a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.', 'armGroupLabels': ['Convalescent plasma group.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11200', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Central Militar', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Carmen G Torres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Central Militar'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'From 6 months after publication', 'ipdSharing': 'YES', 'description': 'Plan to make IPD still not decided and would need approval by regulatory authorities', 'accessCriteria': 'PRIOR APPLICATION'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Central Militar', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}