Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-29 @ 6:13 AM
Study NCT ID:
NCT04747158
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2021-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Convalescent Plasma Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2021-01-27', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (30-day mortality)', 'timeFrame': '30 days', 'description': 'To evaluate the effectiveness of convalescent plasma therapy COVID-19, to decrease mortality in hospitalized patients with COVID-19 and who present some risk factor for clinical deterioration.'}], 'secondaryOutcomes': [{'measure': 'Median length of hospital stay', 'timeFrame': '30 days', 'description': 'To describe the median length of hospital stay in days'}, {'measure': 'Change in clinical status', 'timeFrame': '0, 3, 7 and 14 days', 'description': 'To asses the changes of disease severity, according to the COVID-19 disease severity from the World Health Organization (WHO) Interim guidance.'}, {'measure': 'Change in inflammatory marker: ferritin', 'timeFrame': '0, 7 and 14 days', 'description': 'To measure changes in ferritin (μg/L) at 0, 7 and 14 days'}, {'measure': 'Change in inflammatory marker: D dimer', 'timeFrame': '0, 7 and 14 days', 'description': 'To measure changes in D dimer (mg/L) at 0, 7 and 14 days'}, {'measure': 'Change in inflammatory marker: leukocytes', 'timeFrame': '0, 7 and 14 days', 'description': 'To measure leukocytes (/mm3) changes at 0, 7 and 14 days'}, {'measure': 'Serum Antibody Titers', 'timeFrame': '0, 3 and 7 days', 'description': 'To measure immunoglobulin G (IgG) SARS-CoV 2 titles'}, {'measure': 'Transfer to ICU', 'timeFrame': '30 days', 'description': 'To asses the frequency of patients admitted to ICU'}, {'measure': 'Transfusion related events', 'timeFrame': '4 hours', 'description': 'To asses the frequency of adverse events to convalescent plasma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2 infection', 'Convalescent plasma'], 'conditions': ['SARS-CoV-2 Infection', 'COVID-19 Infection']}, 'referencesModule': {'references': [{'pmid': '33300012', 'type': 'BACKGROUND', 'citation': 'Yoon HA, Bartash R, Gendlina I, Rivera J, Nakouzi A, Bortz RH 3rd, Wirchnianski AS, Paroder M, Fehn K, Serrano-Rahman L, Babb R, Sarwar UN, Haslwanter D, Laudermilch E, Florez C, Dieterle ME, Jangra RK, Fels JM, Tong K, Mariano MC, Vergnolle O, Georgiev GI, Herrera NG, Malonis RJ, Quiroz JA, Morano NC, Krause GJ, Sweeney JM, Cowman K, Allen S, Annam J, Applebaum A, Barboto D, Khokhar A, Lally BJ, Lee A, Lee M, Malaviya A, Sample R, Yang XA, Li Y, Ruiz R, Thota R, Barnhill J, Goldstein DY, Uehlinger J, Garforth SJ, Almo SC, Lai JR, Gil MR, Fox AS, Chandran K, Wang T, Daily JP, Pirofski LA. Treatment of Severe COVID-19 with Convalescent Plasma in the Bronx, NYC. medRxiv [Preprint]. 2020 Dec 4:2020.12.02.20242909. doi: 10.1101/2020.12.02.20242909.'}, {'pmid': '32861333', 'type': 'BACKGROUND', 'citation': 'Joyner MJ, Bruno KA, Klassen SA, Kunze KL, Johnson PW, Lesser ER, Wiggins CC, Senefeld JW, Klompas AM, Hodge DO, Shepherd JRA, Rea RF, Whelan ER, Clayburn AJ, Spiegel MR, Baker SE, Larson KF, Ripoll JG, Andersen KJ, Buras MR, Vogt MNP, Herasevich V, Dennis JJ, Regimbal RJ, Bauer PR, Blair JE, van Buskirk CM, Winters JL, Stubbs JR, van Helmond N, Butterfield BP, Sexton MA, Diaz Soto JC, Paneth NS, Verdun NC, Marks P, Casadevall A, Fairweather D, Carter RE, Wright RS. Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients. Mayo Clin Proc. 2020 Sep;95(9):1888-1897. doi: 10.1016/j.mayocp.2020.06.028. Epub 2020 Jul 19.'}, {'type': 'BACKGROUND', 'citation': 'Clinical Management of COVID-19 - Interim guidance 27 May 2020. WHO reference number: WHO/2019-nCoV/clinical/2020.5'}], 'seeAlsoLinks': [{'url': 'https://datos.conacyt.gov.py/proyectos/pdf/3449', 'label': "Open data' page of projects funded by CONACYT, Paraguay"}]}, 'descriptionModule': {'briefSummary': 'This study is an open-label trial in which hospitalized patients with risk factors of severe coronavirus disease 2019 \\[COVID-19\\] will be receive treatment with convalescent plasma (≤ 15 days from symptoms start).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 Years and older\n* Presence of risk factors of severe COVID 19 diagnosed by quantitative polymerase chain reaction by reverse transcription (RT-qPCR)\n* Patients with no more than 15 days from the onset of symptoms\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severely ill patients admitted directly to the ICU.\n* Need for mechanical ventilation at the time of hospital admission, regardless of the time of clinical evolution.\n* History of previous hypersensitivity to plasma transfusions.\n* History of immunoglobulin A (IgA) deficiency\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04747158', 'acronym': 'TPCC', 'briefTitle': 'COVID-19 Convalescent Plasma Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Asunción'}, 'officialTitle': 'COVID-19 Convalescent Plasma Therapy', 'orgStudyIdInfo': {'id': 'PINV20-388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Convalescent plasma', 'description': 'COVID-19 convalescent plasma', 'interventionNames': ['Biological: Convalescent plasma']}], 'interventions': [{'name': 'Convalescent plasma', 'type': 'BIOLOGICAL', 'description': 'COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2', 'armGroupLabels': ['Convalescent plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111421', 'city': 'Asunción', 'country': 'Paraguay', 'facility': 'Facultad de Ciencias Médicas - Universidad Nacional de Asunción', 'geoPoint': {'lat': -25.28646, 'lon': -57.647}}], 'overallOfficials': [{'name': 'Angelica Jimenez de Samudio, MD,MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facultad de Ciencias Médicas - Universidad Nacional de Asunción'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The investigators will publish the results to compare data with other studies with COVID-19 convalescent plasma patients'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Asunción', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consejo Nacional de Ciencias y Tecnología, Paraguay', 'class': 'UNKNOWN'}, {'name': 'Ministerio de Salud Pública y Bienestar Social, Paraguay', 'class': 'UNKNOWN'}, {'name': 'Centro de información y recursos para el desarrollo, Paraguay', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}