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

4D pharma

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: MRx-4DP0004

Study type: Interventional

Funder types: Industry

Identifiers

NCT04363372

MRx-4DP0004-II-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

MRx-4DP0004

Experimental group

Description:

Patients receiving standard of care will add MRx-4DP0004 to their treatment. MRx-4DP0004 is taken as 2 capsules, twice a day for 14 days. Daily dose is 4 x 10\^9 to 4 x10\^10 colony forming units.

Treatment:

Drug: MRx-4DP0004

Placebo

Placebo Comparator group

Description:

Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days.

Treatment:

Drug: Placebo