Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04716556
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2021-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-30', 'releaseDate': '2022-08-02'}], 'estimatedResultsFirstSubmitDate': '2022-08-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 474}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2021-01-14', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of CD4/CD8 ratio', 'timeFrame': '14 days'}], 'primaryOutcomes': [{'measure': 'Number of patients who meet invasive mechanical ventilation or death', 'timeFrame': 'at 30 days', 'description': 'Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 \\<150 or death'}], 'secondaryOutcomes': [{'measure': 'Mortality rates', 'timeFrame': '30 days', 'description': 'Mortality rates at 30 days'}, {'measure': 'Time to invasive mechanical ventilation or death', 'timeFrame': '30 days', 'description': 'Days from randomization to invasive mechanical ventilation or death'}, {'measure': 'Time to virologic recover', 'timeFrame': '30 days', 'description': 'Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)'}, {'measure': 'Hospitalization time', 'timeFrame': '30 days'}, {'measure': 'Adverse events', 'timeFrame': '30 days', 'description': 'occurrence of Adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plasma'], 'conditions': ['Covid19', 'Coronavirus Infection', 'Pneumonia, Viral']}, 'referencesModule': {'references': [{'pmid': '34842924', 'type': 'DERIVED', 'citation': "Menichetti F, Popoli P, Puopolo M, Spila Alegiani S, Tiseo G, Bartoloni A, De Socio GV, Luchi S, Blanc P, Puoti M, Toschi E, Massari M, Palmisano L, Marano G, Chiamenti M, Martinelli L, Franchi S, Pallotto C, Suardi LR, Luciani Pasqua B, Merli M, Fabiani P, Bertolucci L, Borchi B, Modica S, Moneta S, Marchetti G, d'Arminio Monforte A, Stoppini L, Ferracchiato N, Piconi S, Fabbri C, Beccastrini E, Saccardi R, Giacometti A, Esperti S, Pierotti P, Bernini L, Bianco C, Benedetti S, Lanzi A, Bonfanti P, Massari M, Sani S, Saracino A, Castagna A, Trabace L, Lanza M, Focosi D, Mazzoni A, Pistello M, Falcone M; TSUNAMI Study group. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients With COVID-19 Pneumonia: A Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136246. doi: 10.1001/jamanetworkopen.2021.36246."}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.\n\nPatients with pneumonia due to SARS-CoV-2 will be randomized to receive or not convalescent plasma collected by recovered patients with previous diagnosis of COVID19', 'detailedDescription': 'This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.\n\nPatients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized to receive or not convalescent plasma.\n\nPatients in the plasma group will receive 200-300 ml of plasma collected by recovered patients with previous diagnosis of COVID19, plus standard therapy; Patients in the control group will receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening.\n\nPatients will be followed until day n30 from randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* adult patients with positive RT-PCR test for SARS-CoV2 (nasal swabs or lower respiratory tract sample), diagnosed with pneumonia (\\<= 10 days) according to the following definitions:\n\n * Suggestive radiological imaging (CT, RX, ultrasound);\n * Respiratory failure not fully explained by heart failure or fluid overload;\n * PaO2/FiO2 200-350 mmHg;\n * Signed informed consent\n\nExclusion Criteria:\n\n* need of non invasive or invasive mechanical ventilation at the time of randomization;\n* PaO2/FiO2 \\<200;\n* patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;\n* patients who expressly refuse to adhere the clinical study;\n* use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;\n* patients participating to other clinical trial.'}, 'identificationModule': {'nctId': 'NCT04716556', 'briefTitle': 'TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Superiore di Sanità'}, 'officialTitle': 'TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial', 'orgStudyIdInfo': {'id': 'TSUNAMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Therapy+Convalescent Plasma', 'description': 'Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.', 'interventionNames': ['Biological: Convalescent plasma']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Therapy', 'description': 'Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications'}], 'interventions': [{'name': 'Convalescent plasma', 'type': 'BIOLOGICAL', 'description': 'Convalescent plasma will be collected by healthy donors, recovered by COVID19 and, after standard preparation and dosage of neutralizing antibodies, it will be administered to patients with SARS-CoV2 pneumonia', 'armGroupLabels': ['Standard Therapy+Convalescent Plasma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'country': 'Italy', 'facility': 'SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Arezzo', 'country': 'Italy', 'facility': 'Ospedale di Arezzo', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Clinica Malattie Infettive, Università degli Studi di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'UOC Malattie Infettive - AOU Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'UO PID Tossicologia Applicata - Dip. 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Integrata Università di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Viareggio', 'country': 'Italy', 'facility': 'Ospedale Viareggio', 'geoPoint': {'lat': 43.86693, 'lon': 10.2502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Superiore di Sanità', 'class': 'OTHER'}, 'collaborators': [{'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, {'name': 'Agenzia Italiana del Farmaco', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Coordinator', 'investigatorFullName': 'Elena Toschi', 'investigatorAffiliation': 'Istituto Superiore di Sanità'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-02', 'type': 'RELEASE'}, {'date': '2023-06-30', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Elena Toschi, Research Coordinator, Istituto Superiore di Sanità'}}}}