A study to test the effectiveness and safety of bacteria called Bifidobacterium breve in patients with COVID-19 infections

Phase 1

• Conditions: Symptoms of Covid-19 infection; MedDRA version: 20.0Level: LLTClassification code 10061986Term: SARSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001597-30-GB
• Lead Sponsor: 4D pharma plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Willing and able to sign the informed consent in English and comply with the protocol
2. Age 18 years or older
3. Suspected or confirmed COVID-19 as defined by
a. Positive RNA test for SARS-CoV-2
OR
b. Presenting with symptoms of COVID-19 as determined by the investigator, and
c. A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and
d. Oxygen saturation of <95% on room air, and
e. Chest x-ray with evidence of COVID-19 infection e.g. ground-glass opacities
Up to 2 repeat RNA tests at 2-day intervals may be performed. Participants will be withdrawn from treatment unless at least 1 of 3 RNA tests is positive
4. Requires admission to hospital
5. Able to swallow oral capsules

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Known valvular heart defects, pulmonary hypertension or heart failure
2. Known cystic fibrosis or chronic obstructive pulmonary disease
3. Known GI fistula or malabsorption syndrome
4. Known allergy to ALL of the following antibiotics: ampicillin AND clindamycin AND imipenem
5. Any other condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the study endpoints
6. Participants requiring prophylactic antibiotic treatment or antibiotics for a pre-existing condition at enrolment or within the 2 days prior to start of study treatment
7. Females who are pregnant or breastfeeding or planning to become pregnant during the study or for 30 days after completion of study treatment
8. Unwilling or unable to follow contraceptive requirements as described in section 4.3.2
9. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to start of study treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of MRx-4DP0004 on the clinical outcome of participants with COVID-19 symptoms;Secondary Objective: To determine the safety of MRx-4DP0004 in participants with COVID-19 symptoms;Primary end point(s): Change in mean clinical status score as measured by the WHO Ordinal Scale for Clinical Improvement;Timepoint(s) of evaluation of this end point: Throughout the duration of the trial