TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients
- Conditions
- Pneumonia, ViralCovid19Coronavirus Infection
- Interventions
- Biological: Convalescent plasma
- Registration Number
- NCT04716556
- Lead Sponsor
- Istituto Superiore di Sanità
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Therapy+Convalescent Plasma 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.
- Primary Outcome Measures
Name Time Method Number of patients who meet invasive mechanical ventilation or death at 30 days Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 \<150 or death
- Secondary Outcome Measures
Name Time Method Mortality rates 30 days Mortality rates at 30 days
Hospitalization time 30 days Adverse events 30 days occurrence of Adverse events
Time to invasive mechanical ventilation or death 30 days Days from randomization to invasive mechanical ventilation or death
Time to virologic recover 30 days Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)
Trial Locations
- Locations (48)
Ospedale di Arezzo
🇮🇹Arezzo, Italy
AOU Pisana
🇮🇹Pisa, Italy
Ospedale di Empoli
🇮🇹Empoli, Italy
Malattie Infettive Ravenna
🇮🇹Ravenna, Italy
UOC Malattie Infettive - AOU Bologna
🇮🇹Bologna, Italy
SOD Clinica Malattie Infettive Tropicali, Parassitologia, Epatiti Croniche - AOU Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Clinica Malattie Infettive, Università degli Studi di Bari
🇮🇹Bari, Italy
Ospedale Papa Giovanni XXIII-Dip. emergenza, Urgenza e area critica
🇮🇹Bergamo, 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
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
Ospedale Pistoia
🇮🇹Pistoia, Italy
Ospedale Prato
🇮🇹Prato, 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