Cochrane COVID-19 Study Register
Study record
NCT04393727First Published: 2020 May 20Updated Date: 2021 Jan 29

Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2: a Multicenter Open Label Randomized Control Trial

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (9)
  2. Male and Female
  3. Hospitalization
  4. COVID-19
  5. PaO2 FiO2 measure
  6. Adult
  7. Aged (65+)
  1. Intervention (1)
  2. Convalescent plasma
  1. Comparison (1)
  2. Usual Care
  1. Outcome (5)
  2. Adverse Event
  3. Death
  4. Viral load
  5. Mechanical ventilation
  6. Duration Of Hospital Stay
Reference record

Transfusion of Convalescent Plasma for the Early Treatment of pneumonIa Due to SARSCoV2

NCT04393727
Trial registry record
No Results
No specific therapeutic agents or vaccines for COVID-19 are available. Several therapies, are under investigation, but the antiviral efficacy of these drugs is not yet known. The use of convalescent plasma was recommended as an empirical treatment during outbreaks of Ebola virus in 2014, and a protocol for treatment of Middle East respiratory syndrome coronavirus with convalescent plasma was established in 2015. Accordingly, we hypothesized that use of convalescent plasma transfusion could be beneficial in patients infected with SARS-CoV-2. This is a multicenter prospective randomized clinical trial to evaluate safety and efficacy of early use of convalescent plasma in patients with SARS-CoV2 pneumonia. Primary endpoint will be the efficacy, evaluated as the need of invasive mechanical ventilation defined by PaO2/FiO2 ratio <150. Secondary endpoints will be: mortality rates, time to invasive mechanical ventilation, time to virological cure, length of hospital stay, toxicity. Patients with SARS-CoV2 pneumonia not requiring mechanical ventilation (both non invasive and invasive) will be randomized 1:1 to receive or not convalescent plasma. Patients in the plasma group will receive 200 ml of convalescent plasma, continuing already administered standard therapy, while patients in the control group will continue to receive the standard therapy. A rescue therapy will be allowed in case of clinical worsening. Patients will be followed-up until 30 days from randomization