A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
- Registration Number
- NCT04363372
- Lead Sponsor
- 4D pharma plc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days. MRx-4DP0004 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.
- Primary Outcome Measures
Name Time Method Change in mean clinical status score in each treatment arm Baseline to Day 42 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
- Secondary Outcome Measures
Name Time Method Time to patients with at least 95% oxygen saturation on room air in each treatment arm Day 1 to Day 14 Oxygen saturation will be recorded daily during hospitalisation to determine the mean time for each arm to reach at least 95% saturation
Number of adverse events in each treatment arm Baseline to Day 42 Safety and tolerability will be determined according to clinically relevant reported adverse events
Number of patients with an improvement in clinical status score in each treatment arm Day 1 to Day 42 Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement
Number of patients with a deterioration in clinical status score in each treatment arm Day 1 to Day 42 Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement
Number of patients with at least 95% oxygen saturation on room air in each treatment arm Day 1 to Day 14 Oxygen saturation will be measured as per local standard procedures
Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm Day 1 to Day 14 The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature
Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm Day 1 to Day 14 The NEWS 2 is based on aggregate scoring of physiological measurements including respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature
Number of patients requiring Continuous Positive Airway Pressure in each treatment arm Day 1 to Day 14 Details of required respiratory support will be recorded throughout hospitalisation
Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm Day 1 to Day 14 Details of required respiratory support will be recorded throughout the treatment period
Time to patients requiring Continuous Positive Airway Pressure in each treatment arm Day 1 to Day 14 Details of required respiratory support will be recorded throughout the treatment period
Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm Day 1 to Day 14 Details of required respiratory support will be recorded throughout the treatment period
Time to discharge in each treatment arm Day 1 to Day 42 Length of hospital stay will be compared
Number of deaths in each treatment arm Day 1 to Day 42 All cause mortality will be compared
Trial Locations
- Locations (1)
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom