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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

MRx-4DP0004

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules will be identical in appearance to active product.

Interventions

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MRx-4DP0004

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

Intervention Type DRUG

Placebo

Placebo capsules will be identical in appearance to active product.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No