Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04393727
Status:
TERMINATED
Last Update Posted:
2020-11-12
First Post:
2020-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study was stopped because the Promoter was changed and a new study on convalescent plasma promoted by AIFA was started in Italy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-05-16', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need of invasive mechanical ventilation', 'timeFrame': '30 days', 'description': 'Need of invasive mechanical ventilation defined as PaO2/FiO2 \\<150'}], 'secondaryOutcomes': [{'measure': 'Mortality rates', 'timeFrame': '30 days', 'description': 'Thirty-day mortality rates'}, {'measure': 'Time to invasive mechanical ventilation', 'timeFrame': '30 days', 'description': 'Days from randomization to invasive mechanical ventilation'}, {'measure': 'Time to virologic cure', 'timeFrame': '30 days', 'description': 'Days from randomization to virologic cure defined as 2 consecutive negative nasopharynx swabs'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days', 'description': 'Days from randomization to discharge or death'}, {'measure': 'Adverse events', 'timeFrame': '30 days', 'description': 'Occurrence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'SARS-CoV2', 'pneumonia', 'convalescent plasma'], 'conditions': ['COVID', 'SARS-CoV 2']}, 'referencesModule': {'references': [{'pmid': '32219428', 'type': 'RESULT', 'citation': 'Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.'}]}, 'descriptionModule': {'briefSummary': 'No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2.\n\nThis is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia.\n\nPrimary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio \\<150.\n\nSecondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity.\n\nPatients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.\n\nPatients will be followed-up until 30 days from randomization.', 'detailedDescription': 'This is a multicenter prospective randomized open-label clinical trials. Patients with pneumonia due to SARS-CoV-2 will be included and randomized to receive or not convalescent plasma.\n\nConvalescent plasma will be collected by cured patients with previous diagnosis of COVID-19. More specifically, inclusion and exclusion criteria for donors will be the following.\n\nInclusion criteria for donors:\n\n* age \\> 18 and \\<60 years\n* confirmed diagnosis of COVID-19: PCR on nasopharynx swab or positive IgG\n* presence of 2 negative nasopharynx swabs for patients with previous positive swab and presence of 1 negative nasopharynx swab for patients with positive IgG\n\nExclusion criteria for donors:\n\n* age \\< 18 ys or \\>60 ys\n* other conditions that controindicate blood donation\n\nCollected plasma will undergo all procedures for blood preparation. Plasma will be tested with enzyme-linked immunosorbent assay (ELISA) and neutralizing antibody titers.\n\nPatients eligible for the study will be selected among hospitalized patients with SARS-CoV2 pneumonia. More specifically, the following criteria will used for inclusion in the study.\n\nInclusion criteria for recipients:\n\n* age \\>18 ys\n* confirmed diagnosis of SARS-CoV2 pneumonia\n* PaO2/FiO2 200-350\n\nExclusion criteria for recipients:\n\n* PaO2/FiO2 \\<200\n* need of non invasive or invasive mechanical ventilation\n\nPatients will be randomized 1:1 to receive or not convalescent plasma. All patients will be followed-up for 30 days after randomization.\n\nPrimary endpoint will be the need of mechanical ventilation, defined as PaO2/FiO2 \\<150.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any gender\n* Age \\> 18 years on day of signing informed consent\n* Informed written consent for participation in the study\n* Virological diagnosis of SARS-CoV-2 infection (real-time PCR)\n* Hospitalized due to clinical instrumental diagnosis of pneumonia\n* PaO2/FiO2 ratio 200-350\n\nExclusion Criteria:\n\n* mechanical ventilation (both invasive and non-invasive)\n* PaO2/FiO2\\<200\n* known hypersensitivity to immunoglobulin or blood components'}, 'identificationModule': {'nctId': 'NCT04393727', 'acronym': 'TSUNAMI', 'briefTitle': 'Transfusion of Convalescent Plasma for the Early Treatment of Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero, Universitaria Pisana'}, 'officialTitle': 'Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial', 'orgStudyIdInfo': {'id': 'TSUNAMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients in the intervention group will receive 200 cc of convalescent plasma', 'interventionNames': ['Biological: CONVALESCENT PLASMA']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients will continue to receive standard therapy'}], 'interventions': [{'name': 'CONVALESCENT PLASMA', 'type': 'BIOLOGICAL', 'description': 'Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56124', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Francesco Menichetti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliero, Universitaria Pisana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Francesco Menichetti', 'investigatorAffiliation': 'Azienda Ospedaliero, Universitaria Pisana'}}}}