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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- 4D pharma plc
- Locations
- 1
- Primary Endpoint
- Change in mean clinical status score in each treatment arm
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to sign the consent form
- •Suspected or confirmed COVID-19 as defined by:
- •Positive RNA test for SARS-CoV-2 OR
- •Presenting with symptoms of COVID-19 as determined by the investigator, and
- •A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and
- •Oxygen saturation of <95% on room air, and
- •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
Arms & Interventions
MRx-4DP0004
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.
Intervention: MRx-4DP0004 (Drug)
Placebo
Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in mean clinical status score in each treatment arm
Time Frame: Baseline to Day 42
Clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement where patients are scored on a scale of 0-8 with 0 being uninfected and 8 being dead
Secondary Outcomes
- Number of adverse events in each treatment arm(Baseline to Day 42)
- Number of patients with an improvement in clinical status score in each treatment arm(Day 1 to Day 42)
- Time to patients with at least 95% oxygen saturation on room air in each treatment arm(Day 1 to Day 14)
- Number of patients with a deterioration in clinical status score in each treatment arm(Day 1 to Day 42)
- Number of patients with at least 95% oxygen saturation on room air in each treatment arm(Day 1 to Day 14)
- Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm(Day 1 to Day 14)
- Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm(Day 1 to Day 14)
- Number of patients requiring Continuous Positive Airway Pressure in each treatment arm(Day 1 to Day 14)
- Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm(Day 1 to Day 14)
- Time to patients requiring Continuous Positive Airway Pressure in each treatment arm(Day 1 to Day 14)
- Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm(Day 1 to Day 14)
- Time to discharge in each treatment arm(Day 1 to Day 42)
- Number of deaths in each treatment arm(Day 1 to Day 42)