COVID-19
Conditions
Keywords
MRx-4DP0004, Coronavirus, Live Biotherapeutic Product, SARS-CoV-2, Immunomodulatory
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.
Interventions
DRUGMRx-4DP0004
MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
DRUGPlacebo
Placebo capsules will be identical in appearance to active product.
Sponsors
4D pharma plc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed