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
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.

Completed
COVID19
Coronavirus Infection
Pneumonia, Viral

Biological: 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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

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
Firenze, Italy

SOD Malattie Infettive e Tropicali - AOU Careggi
Firenze, 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
Milano, Italy

Ospedale Luigi Sacco
Milano, Italy

SC Malattie Infettive ASST Grande Ospedale Metropolitano Niguarda
Milano, 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

Istituto Superiore di Sanità
NCT Number
Keywords
plasma
MeSH Terms
COVID-19
Pneumonia
Coronavirus Infections
Pneumonia, Viral