Use of convalescent plasma in the treatment of critically ill COVID-19 patients: a study protocol

Abstract

Use of convalescent plasma (CP) has shown promising results during early studies of COVID-19 patients. This study aims to prepare a protocol for the use of CP to treat critically ill COVID-19 patients. This will be a multicentre, double-blinded, controlled randomised trial. Subjects will be randomly assigned to the treatments, and evaluations will be taken at baseline and at intervals according to the protocol. Only those subjects who meet all inclusion criteria will be enrolled in the study. The experimental treatment group will receive CP at volume of 6 mL/kg divided into two doses separated by 24 hours, in addition to the standard treatment for COVID-19. The control group will receive only the standard treatments. The result assessed at the end of this trial will be the primary and secondary endpoints. The primary endpoints (efficacy indicators) will be the discharge from the ICU, discharge from the hospital, days of hospitalisation, days on mechanical ventilation and death. The main secondary endpoints (safety indicators) will be the severe transfusion reactions and transfusion-transmitted diseases. The authors developed the study protocol using standardised criteria for the development of a clinical trial protocol. This study protocol addressed all aspects that are necessary for the standardised implementation of CP for the treatment of COVID-19 patients, including CP collection, administration, evaluation, and follow up.