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Convalescent Plasma in Severe COVID-19

NCT04403477Phase 2

Key facts

Status: Unknown
Start: May 2020
Primary completion: Jul 2020
Countries: 1
Sponsor: Bangabandhu Sheikh Mujib Medical University
Modality: Biologic

Drugs: convalescent plasma (Heinrich-Heine University, Duesseldorf)
Conditions: coronavirus disease 2019 (COVID-19)

Overview

Phase 2, randomised, open-label trial of convalescent plasma (Heinrich-Heine University, Duesseldorf) in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by Bangabandhu Sheikh Mujib Medical University. Primary endpoints: Proportion of In-hospital mortality at 7 days and Time to death at 7 days. Status: unknown.

Design

3 arms

Study design: RandomizedOpen-label

Standard treatment
Standard supportive care only.
Standard treatment + 200 ml plasma
Standard care plus single transfusion of 200 ml convalescent plasma.
Standard treatment + 400 ml plasma
Standard care plus single transfusion of 400 ml convalescent plasma.

Endpoints

Primary

Proportion of In-hospital mortality7 days
Time to death7 days

Secondary

Fever7 days
Respiratory distress7 days
Saturation of oxygen7 days
Blood pressure7 days
Oxygen requirement7 days
C-reactive ProteinDay 7
FerritinDay 7
SGPTDay 7

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