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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...
Convalescent anti-SARS-CoV-2 MBT Plasma is used for COVID-19 and SARS-CoV-2 infection. It is an investigational monoclonal antibody therapy being developed by Grifols, S.A. (GRFS) for the treatment of these infectious disease conditions.
Convalescent anti-SARS-CoV-2 MBT Plasma targets SARS-CoV-2, the virus that causes COVID-19. It is a convalescent plasma product treated with methylene blue, derived from donors who have recovered from COVID-19, and is being studied for its safety and efficacy in treating the infection.
Convalescent anti-SARS-CoV-2 MBT Plasma is developed by Grifols, S.A., a biopharmaceutical company traded under the ticker GRFS. The company is conducting clinical trials to evaluate this investigational therapy for COVID-19 and SARS-CoV-2 infection.
Convalescent anti-SARS-CoV-2 MBT Plasma is in Phase 2 clinical development. It is an investigational drug and is not yet approved by regulatory authorities. The clinical trials for this therapy have been completed.
Convalescent anti-SARS-CoV-2 MBT Plasma has been studied in two completed Phase 2 trials: NCT04547127, evaluating safety and efficacy in COVID-19 patients in Spain with 200 participants, and NCT04621123, studying early treatment in non-hospitalised mild or moderate COVID-19 patients with 384 participants.
Convalescent anti-SARS-CoV-2 MBT Plasma is a specific type of COVID-19 convalescent plasma that has been treated with methylene blue (MBT). It is derived from donors who have recovered from COVID-19 and is being developed by Grifols for the treatment of SARS-CoV-2 infection.