Trials / Withdrawn
WithdrawnNCT04363372
A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- 4D pharma plc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRx-4DP0004 | MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria. |
| DRUG | Placebo | Placebo capsules will be identical in appearance to active product. |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2020-12-01
- Completion
- 2021-01-01
- First posted
- 2020-04-27
- Last updated
- 2021-06-16
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04363372. Inclusion in this directory is not an endorsement.