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| Name | Class |
|---|---|
| Gruppo Italiano Malattie EMatologiche dell'Adulto | OTHER |
| Agenzia Italiana del Farmaco | OTHER_GOV |
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This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.
Patients 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
This is a multicenter open-label randomized study for the early treatment of pneumonia due to SARS-COV2 with transfusion of convalescent plasma.
Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized to receive or not convalescent plasma.
Patients 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.
Patients will be followed until day n30 from randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy+Convalescent Plasma | Experimental | Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions. |
|
| Standard Therapy | No Intervention | Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who meet invasive mechanical ventilation or death | Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 <150 or death | at 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rates | Mortality rates at 30 days | 30 days |
| Time to invasive mechanical ventilation or death | Days from randomization to invasive mechanical ventilation or death |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of CD4/CD8 ratio | 14 days |
Inclusion Criteria:
Age ≥ 18 years old
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona | Ancona | Italy | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34842924 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 2, 2022 | |
| Reset | Jun 30, 2023 |
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| 30 days |
| Time to virologic recover | Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests) | 30 days |
| Hospitalization time | 30 days |
| Adverse events | occurrence of Adverse events | 30 days |
| Ospedale di Arezzo |
| Arezzo |
| Italy |
| Clinica Malattie Infettive, Università degli Studi di Bari | Bari | Italy |
| Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica | Bergamo | Italy |
| UOC Malattie Infettive - AOU Bologna | Bologna | Italy |
| UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele | Catania | Italy |
| Ospedale Città di Castello | Città di Castello | Italy |
| Ospedale di Empoli | Empoli | Italy |
| UOC Malattie Infettive - ASUR Marche Area Vasta 4 | Fermo | Italy |
| UOC Malattie Infettive - AOU Ferrara | Ferrara | Italy |
| Ospedale Santa Maria Annunziata | Florence | Italy |
| SOD Malattie Infettive e Tropicali - AOU Careggi | Florence | Italy |
| Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia | Foggia | Italy |
| Nuovo Ospedale S. Giovanni Battista Usl Umbria2 | Foligno | Italy |
| U.O.C. Malattie Infettive ASL Frosinone | Frosinone | Italy |
| U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino | Genova | Italy |
| Ospedale di Grosseto | Grosseto | Italy |
| ASL 5 Spezzina - SC Malattie Infettive | La Spezia | Italy |
| ASST Lecco - Malattie Infettive | Lecco | Italy |
| Ospedale di Livorno | Livorno | Italy |
| Ospedale di Lucca | Lucca | Italy |
| S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma | Mantua | Italy |
| Ospedale Dell'Angelo - UOC Malattie Infettive | Mestre | Italy |
| ASST Santi Paolo e Carlo | Milan | Italy |
| Ospedale Luigi Sacco | Milan | Italy |
| SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy |
| Ospedale San Gerardo | Monza | Italy |
| Malattie Infettive - AOU Federico II di Napoli | Naples | Italy |
| UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli" | Naples | Italy |
| UOC Malattie Infettive e Tropicali - AOU Policlinico | Palermo | Italy |
| Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo | Pavia | Italy |
| Azienda Ospedaliero-Universitaria di Perugia | Perugia | Italy |
| UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord | Pesaro | Italy |
| AOU Pisana | Pisa | Italy |
| Ospedale Pistoia | Pistoia | Italy |
| Ospedale Prato | Prato | Italy |
| Malattie Infettive Ravenna | Ravenna | Italy |
| UOC Malattie Infettive - AUSL Reggio Emilia | Reggio Emilia | Italy |
| Malattie Infettive - Rimini Forlì Cesena | Rimini | Italy |
| Campus Bio Medico - UO Anestesia e Rianimazione | Roma | Italy |
| ASL 1 Imperiese - SC Malattie Infettive | Sanremo | Italy |
| ASL 2 Savonese - SC Malattie Infettive | Savona | Italy |
| Ospedale di Siena | Siena | Italy |
| Ospedale di Sondrio - dipartimento di Medicina | Sondrio | Italy |
| AOU di Terni | Terni | Italy |
| Ospedale Ca Foncello - UOC Malattie Infettive | Treviso | Italy |
| A.O. Integrata Università di Verona | Verona | Italy |
| Ospedale Viareggio | Viareggio | Italy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 2, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D011024 | Pneumonia, Viral |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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