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.
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.
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
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Dinesh Saralaya, MBBS, MD, MRCP, FRCP, Principal Investigator
Bradford Royal Infirmary