drugset / Trial / NCT04363372
A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of MRx-4DP0004 in patients with COVID-19. 90 hospitalised patients will be enrolled and randomised (2:1) to receive MRx-4DP0004 or placebo for up to 14 days. MRx-4DP0004 is an immunomodulating Live Biotherapeutic Product (LBP) which is expected to prevent or reduce the hyperinflammatory response to SARS-CoV-2 infection without impairing viral clearance.
Timeline
- Start
- 2020-08
- Primary completion
- 2020-12
- Completion
- 2021-01
Outcome
Outcome not reported
Stopped (Enrollment): “Recruitment Issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MRx-4DP0004 | Other / unclassified | 4e+09 unknown | Oral |
| Subject | MRx-4DP0004 | Other / unclassified | 4e+10 unknown | Oral |