Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04547127 | A Study to Evaluate Safety and Efficacy of Convalescent Methylene Blue Treated (MBT) Plasma From Donors Recovered From Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 200 | — | — | Apr 29, 2020 | Feb 4, 2021 | Mar 3, 2021 | 12 | Spain |
| Arm | Type | Description |
|---|---|---|
| Convalescent anti-SARS-CoV-2 MBT Plasma + SMT | EXPERIMENTAL | Participants will receive 2 consecutive transfusions of 200 to 250 milliliters (ml) of ABO-compatible convalescent plasma with each unit of plasma, obtained from the same convalescent donor, which will be administered on Day 1 using standard procedures for administration of fresh frozen plasma. Participants weighing less than 45 kilograms (kg) will receive two transfusions of 10 ml of convalescent plasma per kilogram of body weight with each unit of plasma obtained from the same convalescent donor. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | ACTIVE_COMPARATOR | Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29. |
| Name | Type | Description |
|---|---|---|
| Convalescent anti-SARS-CoV-2 MBT Plasma | BIOLOGICAL | Intravenous infusion. |
| Standard Medical Treatment | DRUG | SMT |
Inclusion Criteria: * Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the intensive care unit (ICU) for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission. * Subject...