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

NCT04363372 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • 4D pharma plc

    lead INDUSTRY

Principal Investigators

  • Dinesh Saralaya, MBBS, MD, MRCP, FRCP · Bradford Royal Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2020-12-31
Completion
2021-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04363372 on ClinicalTrials.gov