A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)
NCT04547127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2021-03-03
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.
Conditions
Interventions
- BIOLOGICAL
-
Convalescent anti-SARS-CoV-2 MBT Plasma
Intravenous infusion.
- DRUG
-
Standard Medical Treatment
SMT
Sponsors & Collaborators
-
Instituto Grifols, S.A.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-04-29
- Primary Completion
- 2021-02-04
- Completion
- 2021-02-04
Countries
- Spain
Study Locations
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