Clinical trial NCT04363372: A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
Official title: A Pilot, Multiple Dose Study to Evaluate the Efficacy and Safety of MRx-4DP0004 in Hospitalised Patients With Symptoms of COVID-19 (SARS-CoV-2 Infection)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
Keywords: MRx-4DP0004
Coronavirus
Live Biotherapeutic Product
SARS-CoV-2
Immunomodulatory
Lead sponsor: 4D pharma plc
Sponsor class: INDUSTRY
First posted: 2020-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean clinical status score in each treatment arm
timeFrame: Baseline to Day 42
Secondary outcomes:
measure: Number of adverse events in each treatment arm
timeFrame: Baseline to Day 42
measure: Number of patients with an improvement in clinical status score in each treatment arm
timeFrame: Day 1 to Day 42
measure: Number of patients with a deterioration in clinical status score in each treatment arm
timeFrame: Day 1 to Day 42
measure: Number of patients with at least 95% oxygen saturation on room air in each treatment arm
timeFrame: Day 1 to Day 14
measure: Time to patients with at least 95% oxygen saturation on room air in each treatment arm
timeFrame: Day 1 to Day 14
measure: Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm
timeFrame: Day 1 to Day 14
measure: Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm
timeFrame: Day 1 to Day 14
measure: Number of patients requiring Continuous Positive Airway Pressure in each treatment arm
timeFrame: Day 1 to Day 14
measure: Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
timeFrame: Day 1 to Day 14
measure: Time to patients requiring Continuous Positive Airway Pressure in each treatment arm
timeFrame: Day 1 to Day 14
measure: Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
timeFrame: Day 1 to Day 14
measure: Time to discharge in each treatment arm
timeFrame: Day 1 to Day 42
measure: Number of deaths in each treatment arm
timeFrame: Day 1 to Day 42
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
affiliation: Bradford Royal Infirmary
name: Dinesh Saralaya, MBBS, MD, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References: