drugset / Trial / NCT04363372

A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19

NCT04363372 ↗

Phase 2 Withdrawn 4D pharma plc
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

EvaluationDrugModalityDoseRoute
Subject MRx-4DP0004 Other / unclassified 4e+09 unknown Oral
Subject MRx-4DP0004 Other / unclassified 4e+10 unknown Oral

Indications