TranSfUsion of coNvalescent plAsma for the Early Treatment of pneuMonIa in COVID-19 Patients

Istituto Superiore di Sanità

Status

Completed

Conditions

Covid19

Pneumonia, Viral

Coronavirus Infection

Treatments

Biological: Convalescent plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT04716556

TSUNAMI

Details and patient eligibility

About

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

Full 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.

Enrollment

474 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.