drugset / Trial / NCT04547127

A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)

NCT04547127 ↗

Phase 2 Completed 200 enrolled Grifols, S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine if Convalescent anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Methylene Blue Treated (MBT) plasma plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the intensive care unit (ICU) through Day 29.

Timeline

Start
2020-04-29
Primary completion
2021-02-04
Completion
2021-02-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Convalescent anti-SARS-CoV-2 MBT Plasma Unknown 10 unknown Intravenous
Subject Convalescent anti-SARS-CoV-2 MBT Plasma Unknown 200 ml Intravenous
Subject Convalescent anti-SARS-CoV-2 MBT Plasma Unknown 250 ml Intravenous

Indications