Treatment of Patients With COVID-19 With Convalescent Plasma
Treatment of Patients With COVID-19 With Convalescent Plasma
The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020,
 there have been more than 450.000 cases with more than 28.000 deaths, with daily increases.
 The present study proposes to evaluate the efficacy and safety of convalescent plasma in
 treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled
 study
Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B-
 standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and
 convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage
 model will be used, which will allow an interim analysis after the inclusion of 30 patients,
 with repeated interim analyses for every 30 additional patients. With this, we expect to
 define not only the efficacy of convalescent plasma, but also the volume of plasma needed if
 efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma
 group is proven, so that all severely ill patients as defined in the study can receive the
 convalescent plasma treatment. The same will occur if there is no difference in primary
 outcome with the use of convalescent plasma or serious adverse effects.
Inclusion Criteria:

 -  Age = or > than 18 years; .

 -  Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since
 symptom onset less than 10 days at the time of screening; - . Presence of COVID-19
 pneumonia, with a typical, indeterminate or atypical compatible image in a chest
 tomography exam (see definition below) -

 -  Presence of one of the following criteria:

 -  Need for> 3L of O2 in the catheter / mask or> 25% in the Venturi mask to maintain O2
 saturation> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 <300mmHg
 If intubated, within 48 hours of orotracheal intubation

 -  Absence of a history of serious adverse reactions to transfusion, for example,
 anaphylaxis; - .Participation approval by the research clinician

 Exclusion Criteria:

 -  Already enrolled in another clinical trial evaluating antiviral or immunobiological
 therapy for the treatment of COVID-19.

 -  IgA deficiency

 -  Presence of a clinical condition that does not allow infusion of 400 ml of volume at
 clinical discretion

 -  Pregnancy or breastfeeding

 -  Receipt of immunoglobulin in the last 30 days

 -  Presence of significant risk of death within the next 48 hours at clinical discretion.