Status:
WITHDRAWN
A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
Lead Sponsor:
4D pharma plc
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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:...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04363372
Start Date
August 1 2020
End Date
January 1 2021
Last Update
June 16 2021
Active Locations (1)
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1
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom