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)

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.

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