Clinical trial NCT04716556: TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
Official title: TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa Due to SARS-CoV2 (TSUNAMI Study): a Multicenter Open Label Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Coronavirus Infection
Pneumonia, Viral
Keywords: plasma
Lead sponsor: Istituto Superiore di Sanità
Sponsor class: OTHER
Collaborators: name: Gruppo Italiano Malattie EMatologiche dell'Adulto
name: Agenzia Italiana del Farmaco
First posted: 2021-01-20
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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:

  * 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:

* need of non invasive or invasive mechanical ventilation at the time of randomization;
* 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.

Primary outcomes:
measure: Number of patients who meet invasive mechanical ventilation or death
timeFrame: at 30 days
Secondary outcomes:
measure: Mortality rates
timeFrame: 30 days
measure: Time to invasive mechanical ventilation or death
timeFrame: 30 days
measure: Time to virologic recover
timeFrame: 30 days
measure: Hospitalization time
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
measure: Evaluation of CD4/CD8 ratio
timeFrame: 14 days
Locations:
city: Ancona
country: Italy
facility: SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
city: Arezzo
country: Italy
facility: Ospedale di Arezzo
city: Bari
country: Italy
facility: Clinica Malattie Infettive, Università degli Studi di Bari
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
city: Bologna
country: Italy
facility: UOC Malattie Infettive - AOU Bologna
city: Catania
country: Italy
facility: UO PID Tossicologia Applicata - Dip. Scienze Biomediche e Biotecnologiche - Università di Catania - AOU Policlinico Vittorio Emanuele
city: Città Di Castello
country: Italy
facility: Ospedale Città di Castello
city: Empoli
country: Italy
facility: Ospedale di Empoli
city: Fermo
country: Italy
facility: UOC Malattie Infettive - ASUR Marche Area Vasta 4
city: Ferrara
country: Italy
facility: UOC Malattie Infettive - AOU Ferrara
city: Firenze
country: Italy
facility: Ospedale Santa Maria Annunziata
city: Firenze
country: Italy
facility: SOD Malattie Infettive e Tropicali - AOU Careggi
city: Foggia
country: Italy
facility: Dip.Medicina Clinica e Sperimentale - Policlinico "Riuniti" di Foggia
city: Foligno
country: Italy
facility: Nuovo Ospedale S. Giovanni Battista Usl Umbria2
city: Frosinone
country: Italy
facility: U.O.C. Malattie Infettive ASL Frosinone
city: Genova
country: Italy
facility: U.O. Malattie Infettive IRCCS-Ospedale Policlinico San Martino
city: Grosseto
country: Italy
facility: Ospedale di Grosseto
city: La Spezia
country: Italy
facility: ASL 5 Spezzina - SC Malattie Infettive
city: Lecco
country: Italy
facility: ASST Lecco - Malattie Infettive
city: Livorno
country: Italy
facility: Ospedale di Livorno
city: Lucca
country: Italy
facility: Ospedale di Lucca
city: Mantova
country: Italy
facility: S.C. Pneumologia e Utir ASST Mantova - Ospedale Carlo Poma
city: Mestre
country: Italy
facility: Ospedale Dell'Angelo - UOC Malattie Infettive
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Milano
country: Italy
facility: SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Napoli
country: Italy
facility: Malattie Infettive - AOU Federico II di Napoli
city: Napoli
country: Italy
facility: UOC Malattie Infettive ad indirizzo Respiratorio - PO Cotugno - AORN "Dei Colli"
city: Palermo
country: Italy
facility: UOC Malattie Infettive e Tropicali - AOU Policlinico
city: Pavia
country: Italy
facility: Dip. Medicina Diagnost. e Servizi Fondazione IRCCS Policlinico San Matteo
city: Perugia
country: Italy
facility: Azienda Ospedaliero-Universitaria di Perugia
city: Pesaro
country: Italy
facility: UOC Malattie Infettive - Azienda Ospedali Riuniti Marche Nord
city: Pisa
country: Italy
facility: AOU Pisana
city: Pistoia
country: Italy
facility: Ospedale Pistoia
city: Prato
country: Italy
facility: Ospedale Prato
city: Ravenna
country: Italy
facility: Malattie Infettive Ravenna
city: Reggio Emilia
country: Italy
facility: UOC Malattie Infettive - AUSL Reggio Emilia
city: Rimini
country: Italy
facility: Malattie Infettive - Rimini Forlì Cesena
city: Roma
country: Italy
facility: Campus Bio Medico - UO Anestesia e Rianimazione
city: Sanremo
country: Italy
facility: ASL 1 Imperiese - SC Malattie Infettive
city: Savona
country: Italy
facility: ASL 2 Savonese - SC Malattie Infettive
city: Siena
country: Italy
facility: Ospedale di Siena
city: Sondrio
country: Italy
facility: Ospedale di Sondrio - dipartimento di Medicina
city: Terni
country: Italy
facility: AOU di Terni
city: Treviso
country: Italy
facility: Ospedale Ca Foncello - UOC Malattie Infettive
city: Verona
country: Italy
facility: A.O. Integrata Università di Verona
city: Viareggio
country: Italy
facility: Ospedale Viareggio
Study officials:
References:
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.