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

4D pharma plc

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

COVID-19

Interventions

MRx-4DP0004DRUG

MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.

PlaceboDRUG

Placebo capsules will be identical in appearance to active product.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Outcomes

Primary Outcomes

Change in mean clinical status score in each treatment arm

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

Time frame: Baseline to Day 42

Secondary Outcomes

Number of adverse events in each treatment arm

Safety and tolerability will be determined according to clinically relevant reported adverse events

Time frame: Baseline to Day 42

Number of patients with an improvement in clinical status score in each treatment arm

Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

Time frame: Day 1 to Day 42

Number of patients with a deterioration in clinical status score in each treatment arm

Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

Time frame: Day 1 to Day 42

Number of patients with at least 95% oxygen saturation on room air in each treatment arm

Oxygen saturation will be measured as per local standard procedures

Time frame: Day 1 to Day 14

Time to patients with at least 95% oxygen saturation on room air in each treatment arm

Oxygen saturation will be recorded daily during hospitalisation to determine the mean time for each arm to reach at least 95% saturation

Time frame: Day 1 to Day 14

Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm

Data from ClinicalTrials.gov

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