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

Istituto Superiore di Sanità474 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

474

Conditions

Covid19 Coronavirus Infection Pneumonia, Viral

Interventions

Convalescent plasmaBIOLOGICAL

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (48)

Outcomes

Primary Outcomes

Number of patients who meet invasive mechanical ventilation or death

Number of patients who meet invasive mechanical ventilation defined as PaO2/FiO2 \<150 or death

Time frame: at 30 days

Secondary Outcomes

Mortality rates

Mortality rates at 30 days

Time frame: 30 days

Time to invasive mechanical ventilation or death

Days from randomization to invasive mechanical ventilation or death

Time frame: 30 days

Time to virologic recover

Days from randomization to virologic recover (defined as 2 consecutive negative nasopharynx tests)

Time frame: 30 days

Hospitalization time

Time frame: 30 days

Adverse events

occurrence of Adverse events

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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