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.
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
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.
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