Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT04332835
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'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': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093522', 'term': 'COVID-19 Serotherapy'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single Blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Viral Load', 'timeFrame': 'Days 0, 4, 7, 14 and 28', 'description': 'Copies of COVID-19 per ml'}, {'measure': 'Change in Immunoglobulin G COVID-19 Titers', 'timeFrame': 'Days 0, 4, 7, 14 and 28', 'description': 'Immunoglobulin G COVID-19 antibodies'}], 'secondaryOutcomes': [{'measure': 'Intensive Care Unit Admission', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Proportion of patients with Intensive Care Unit Admission requirement (days 7, 14 and 28)'}, {'measure': 'Length of Intensive Care Unit stay', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Days of Intensive Care Unit management (days 7, 14 and 28)'}, {'measure': 'Length of hospital stay (days)', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Days of Hospitalization (days 7, 14 and 28)'}, {'measure': 'Requirement of mechanical ventilation', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Proportion of patients with mechanical ventilation (days 7, 14 and 28)'}, {'measure': 'Duration (days) of mechanical ventilation', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Days with mechanical ventilation (days 7, 14 and 28)'}, {'measure': 'Clinical status assessed according to the World Health Organization guideline', 'timeFrame': 'Days 7, 14 and 28', 'description': '1\\. Hospital discharge; 2. Hospitalization, not requiring supplemental oxygen; 3. Hospitalization, requiring supplemental oxygen (but not Noninvasive Ventilation/ HFNC); 4. Intensive care unit/hospitalization, requiring Noninvasive Ventilation/ HFNC therapy; 5. Intensive care unit, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 6. Death. (days 7, 14 and 28)'}, {'measure': 'Mortality', 'timeFrame': 'Days 7, 14 and 28', 'description': 'Proportion of death patients at days 7, 14 and 28'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Coronavirus Disease 2019'], 'conditions': ['Coronavirus', 'Coronavirus Infection']}, 'referencesModule': {'references': [{'pmid': '31986264', 'type': 'BACKGROUND', 'citation': 'Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.'}, {'pmid': '32134116', 'type': 'BACKGROUND', 'citation': 'Wang Y, Wang Y, Chen Y, Qin Q. Unique epidemiological and clinical features of the emerging 2019 novel coronavirus pneumonia (COVID-19) implicate special control measures. J Med Virol. 2020 Jun;92(6):568-576. doi: 10.1002/jmv.25748. Epub 2020 Mar 29.'}, {'pmid': '32125362', 'type': 'BACKGROUND', 'citation': 'Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204.'}, {'type': 'BACKGROUND', 'citation': 'Infectious, D. & Outbreaks, D. Maintaining a safe and adequate blood supply during the pandemic outbreak of coronavirus disease ( COVID-19 ). OMS 1-5 (2020)'}, {'pmid': '35761219', 'type': 'DERIVED', 'citation': 'Rojas M, Rodriguez Y, Hernandez JC, Diaz-Coronado JC, Vergara JAD, Velez VP, Mancilla JP, Araujo I, Yepes JT, Ricaurte OB, Pardo-Oviedo JM, Monsalve DM, Acosta-Ampudia Y, Ramirez-Santana C, Garcia PG, Landinez LA, Correales LD, Grass JS, Perez CR, Lopez GS, Mateus N, Mancera L, Devia RR, Orjuela JE, Parra-Moreno CR, Buitrago AA, Ordonez IE, Osorio CF, Ballesteros N, Patino LH, Castaneda S, Munoz M, Ramirez JD, Bastard P, Gervais A, Bizien L, Casanova JL, Camacho B, Gallo JE, Gomez O, Rojas-Villarraga A, Perez CE, Manrique R, Mantilla RD, Anaya JM. Safety and efficacy of convalescent plasma for severe COVID-19: a randomized, single blinded, parallel, controlled clinical study. BMC Infect Dis. 2022 Jun 27;22(1):575. doi: 10.1186/s12879-022-07560-7.'}]}, 'descriptionModule': {'briefSummary': 'Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks', 'detailedDescription': 'The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia, and through a donation of plasma from the recovered, the subsequent transfusion of this to patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific evidence regarding the application of convalescent plasma for emergency viral outbreaks and has recommended the following protocol'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Fulfilling all the following criteria\n\n1. Olerder than 18.\n2. Hospitalized participants with diagnosis of COVID 19 by Real Time - Polymerase Chain Reaction.\n3. Severe cases according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 7)".\n4. Sequential Organ Failure Assessment score (SOFA) \\< 6.\n5. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Female subjects who are pregnant or breastfeeding.\n2. Patients with prior allergic reactions to transfusions.\n3. Critical ill patients in intensive care units with requierment of Invasive Mechanical Venitlation.\n4. Patients with surgical procedures in the last 30 days.\n5. Patients with active treatment for cancer (Radiotherapy or Chemotherapy).\n6. HIV diagnosed patients with viral failure (detectable viral load\\> 1000 copies / ml persistent, two consecutive viral load measurements within a 3 month interval, with medication adherence between measurements after at least 6 months of starting a new regimen antiretrovirals).\n7. Demonstrated coinfection that explains the patient\'s symptoms\n8. End-stage chronic kidney disease (Glomerular Filtration Rate \\<15 ml / min / 1.73 m2).\n9. Child Pugh C stage liver cirrhosis.\n10. High cardiac output diseases.\n11. Autoimmune diseases or Immunoglobulin A nephropathy.\n12. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.'}, 'identificationModule': {'nctId': 'NCT04332835', 'acronym': 'CP-COVID-19', 'briefTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Universidad del Rosario'}, 'officialTitle': 'Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study', 'orgStudyIdInfo': {'id': 'ABN011-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Participants included in the experimental group will receive 500 milliliters of convalescent plasma, distributed in two 250 milliliters transfusions on the first and second day after starting the protocol. Simultaneously, they will receive the standard therapy defined by institutional protocol.', 'interventionNames': ['Drug: Plasma', 'Drug: Standard Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants included in the control group will receive standard therapy defined by institutional protocol.', 'interventionNames': ['Drug: Standard Therapy']}], 'interventions': [{'name': 'Plasma', 'type': 'DRUG', 'otherNames': ['Convalescent Plasma COVID-19'], 'description': 'Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Standard Therapy', 'type': 'DRUG', 'description': 'Standard therapy defined by institutional protocol.', 'armGroupLabels': ['Control Group', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11100', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Universidad del Rosario'}], 'overallOfficials': [{'name': 'Juan M Anaya Cabrera, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad del Rosario'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad del Rosario', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Universitaria de Ciencias de la Salud', 'class': 'OTHER'}, {'name': 'CES University', 'class': 'OTHER'}, {'name': 'Instituto Distrital de Ciencia Biotecnología e Innovacion en Salud', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Principal Investigator', 'investigatorFullName': 'Juan Manuel Anaya Cabrera', 'investigatorAffiliation': 'Universidad del Rosario'}}}}