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

NCT04363372 | Withdrawn Phase 2

• 1 other identifier: MRx-4DP0004-II-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

MRx-4DP0004; Coronavirus; Live Biotherapeutic Product; SARS-CoV-2; Immunomodulatory

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to Day 42

Secondary Outcomes (13)

• 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

• 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

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

  Day 1 to Day 14

Study Arms (2)

MRx-4DP0004

EXPERIMENTAL

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.

Drug: MRx-4DP0004

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MRx-4DP0004 DRUG

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

MRx-4DP0004

Placebo DRUG

Placebo capsules will be identical in appearance to active product.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• 4D pharma plc: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dinesh Saralaya, MBBS, MD, MRCP, FRCP

  Bradford Royal Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 27, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: June 16, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)