Back to resultsA Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
MRx-4DP0004
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring MRx-4DP0004, Coronavirus, Live Biotherapeutic Product, SARS-CoV-2, Immunomodulatory
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- University Hospitals Plymouth NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MRx-4DP0004
Placebo
Arm Description
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.
Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days.
Outcomes
Primary Outcome Measures
Change in mean clinical status score in each treatment arm
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
Number of adverse events in each treatment arm
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
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
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
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
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
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
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
Details of required respiratory support will be recorded throughout hospitalisation
Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Time to patients requiring Continuous Positive Airway Pressure in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Time to discharge in each treatment arm
Length of hospital stay will be compared
Number of deaths in each treatment arm
All cause mortality will be compared
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04363372
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment Issues
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4D pharma plc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
MRx-4DP0004, Coronavirus, Live Biotherapeutic Product, SARS-CoV-2, Immunomodulatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRx-4DP0004
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days.
Intervention Type
Drug
Intervention Name(s)
MRx-4DP0004
Intervention Description
MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules will be identical in appearance to active product.
Primary Outcome Measure Information:
Title
Change in mean clinical status score in each treatment arm
Description
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
Time Frame
Baseline to Day 42
Secondary Outcome Measure Information:
Title
Number of adverse events in each treatment arm
Description
Safety and tolerability will be determined according to clinically relevant reported adverse events
Time Frame
Baseline to Day 42
Title
Number of patients with an improvement in clinical status score in each treatment arm
Description
Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement
Time Frame
Day 1 to Day 42
Title
Number of patients with a deterioration in clinical status score in each treatment arm
Description
Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement
Time Frame
Day 1 to Day 42
Title
Number of patients with at least 95% oxygen saturation on room air in each treatment arm
Description
Oxygen saturation will be measured as per local standard procedures
Time Frame
Day 1 to Day 14
Title
Time to patients with at least 95% oxygen saturation on room air in each treatment arm
Description
Oxygen saturation will be recorded daily during hospitalisation to determine the mean time for each arm to reach at least 95% saturation
Time Frame
Day 1 to Day 14
Title
Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm
Description
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
Time Frame
Day 1 to Day 14
Title
Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm
Description
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
Time Frame
Day 1 to Day 14
Title
Number of patients requiring Continuous Positive Airway Pressure in each treatment arm
Description
Details of required respiratory support will be recorded throughout hospitalisation
Time Frame
Day 1 to Day 14
Title
Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Description
Details of required respiratory support will be recorded throughout the treatment period
Time Frame
Day 1 to Day 14
Title
Time to patients requiring Continuous Positive Airway Pressure in each treatment arm
Description
Details of required respiratory support will be recorded throughout the treatment period
Time Frame
Day 1 to Day 14
Title
Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Description
Details of required respiratory support will be recorded throughout the treatment period
Time Frame
Day 1 to Day 14
Title
Time to discharge in each treatment arm
Description
Length of hospital stay will be compared
Time Frame
Day 1 to Day 42
Title
Number of deaths in each treatment arm
Description
All cause mortality will be compared
Time Frame
Day 1 to Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dinesh Saralaya, MBBS, MD, MRCP, FRCP
Organizational Affiliation
Bradford Royal Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Plymouth NHS Trust
City
Plymouth
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
We'll reach out to this number within 24 hrs