TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
NCT ID: NCT04716556
Last Updated: 2021-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
474 participants
INTERVENTIONAL
2020-07-16
2021-05-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Therapy+Convalescent Plasma
Patients will receive standard therapy + 200-300 ml of convalescent plasma for a maximum of 3 times in 5 days, according to clinical conditions.
Convalescent plasma
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
Standard Therapy
Patients will receive standard therapy for the treatment of SARS-CoV2 infection, according to AIFA indications
No interventions assigned to this group
Interventions
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Convalescent plasma
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
Eligibility Criteria
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Inclusion Criteria
* 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:
* Suggestive radiological imaging (CT, RX, ultrasound);
* Respiratory failure not fully explained by heart failure or fluid overload;
* PaO2/FiO2 200-350 mmHg;
* Signed informed consent
Exclusion Criteria
* PaO2/FiO2 \<200;
* patients with hypersensitivity or allergic reaction to blood products or immunoglobulins;
* patients who expressly refuse to adhere the clinical study;
* use of IL-6 Receptor inhibitors, IL-1 inhibitors, JAK inhibitors, TNF inhibitors;
* patients participating to other clinical trial.
18 Years
ALL
No
Sponsors
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Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Agenzia Italiana del Farmaco
OTHER_GOV
Istituto Superiore di Sanità
OTHER
Responsible Party
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Elena Toschi
Research Coordinator
Locations
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SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
Ancona, , Italy
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
Mantova, , 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
Napoli, , Italy
UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
Napoli, , 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
Countries
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References
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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.
Other Identifiers
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TSUNAMI
Identifier Type: -
Identifier Source: org_study_id
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