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

• Status: Withdrawn
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 4D pharma plc

Criteria

Inclusion Criteria:

• Willing and able to sign the consent form

• Suspected or confirmed COVID-19 as defined by:

1. Positive RNA test for SARS-CoV-2 OR

2. Presenting with symptoms of COVID-19 as determined by the investigator, and

3. A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and

4. Oxygen saturation of <95% on room air, and

5. Chest X-ray with evidence of COVID-19 e.g. ground-glass opacities

• Requires admission to hospital

• Able to swallow oral capsules

Exclusion Criteria:

• Known valvular heart defects, pulmonary hypertension or heart failure

• Known to have cystic fibrosis

• GI fistula or malabsorption syndrome

• Known allergy to ampicillin, clindamycin and imipenem

• Any other condition which, in the opinion of the investigator, would prevent full participation in the study or would interfere with the evaluation of the study endpoints

• Antibiotic treatment at enrolment or within 2 days prior

• Pregnant or breastfeeding females

• Unable or unwilling to follow contraception requirements

• Concurrent participation in another interventional clinical trial at enrolment or within 30 days prior