NCT04415086

Treatment of Patients With COVID-19 With Convalescent Plasma

Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	convalescent plasma	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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-02-15
• Completion: 2022-02-15
• First posted: 2020-06-04
• Last updated: 2022-05-19

Locations

1 site across 1 country: Brazil