Trials / Completed
CompletedNCT04547127
A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19)
A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) With Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit (ICU)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Instituto Grifols, S.A. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Convalescent anti-SARS-CoV-2 MBT Plasma | Intravenous infusion. |
| DRUG | Standard Medical Treatment | SMT |
Timeline
- Start date
- 2020-04-29
- Primary completion
- 2021-02-04
- Completion
- 2021-02-04
- First posted
- 2020-09-14
- Last updated
- 2021-03-03
Locations
12 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04547127. Inclusion in this directory is not an endorsement.