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Convalescent anti-SARS-CoV-2 MBT plasma · 2 trials · 3 indications
Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing the rate of hospitalization in non-hospitalised mild or moderate COVID-19 patients.
Assess the therapeutic potential of early administration of convalescent MBT plasma in reducing SARS-CoV-2 viral load at day 7, measured by quantitative RT-PCR (RT-qPCR) in non-hospitalised mild or moderate COVID-19 patients.
| Arm | Type | Description |
|---|---|---|
| Experimental group | EXPERIMENTAL | Subjects randomized to convalescent anti-SARS-CoV-2 MBT plasma plus SMT will receive one infusion of 200 to 300 ml of ABO-compatible convalescent plasma obtained from a convalescent donor. |
| Control Group | PLACEBO_COMPARATOR | Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300 ml of sterile saline solution 0.9%. |
| 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 | Subjects randomized to combination convalescent anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml of ABO-compatible convalescent plasma |
| Control Group | OTHER | Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300ml of sterile saline solution 0.9%. |
| Standard Medical Treatment | DRUG | SMT |
Inclusion Criteria: 1. 1\. Adult male or female individuals of ≥50 years old. 2. 2\. In women of childbearing potential1, negative pregnancy test at inclusion/baseline. 3. 3\. Has confirmed SARS-CoV-2 infection as determined by PCR or validated antigen rapid diagnostic test2 from nasopharyngeal swa...
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