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A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363372
Recruitment Status : Withdrawn (Recruitment Issues)
First Posted : April 27, 2020
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
4D pharma plc

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: MRx-4DP0004 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: MRx-4DP0004
MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
Placebo Comparator: Placebo
Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days.
 Drug: Placebo
Placebo capsules will be identical in appearance to active product.


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean clinical status score in each treatment arm [ Time Frame: 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 :
  1. Number of adverse events in each treatment arm [ Time Frame: Baseline to Day 42 ]
    Safety and tolerability will be determined according to clinically relevant reported adverse events

  2. Number of patients with an improvement in clinical status score in each treatment arm [ Time Frame: Day 1 to Day 42 ]
    Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

  3. Number of patients with a deterioration in clinical status score in each treatment arm [ Time Frame: Day 1 to Day 42 ]
    Point changes in clinical status score will be measured using the WHO Ordinal Scale for Clinical Improvement

  4. Number of patients with at least 95% oxygen saturation on room air in each treatment arm [ Time Frame: Day 1 to Day 14 ]
    Oxygen saturation will be measured as per local standard procedures

  5. Time to patients with at least 95% oxygen saturation on room air in each treatment arm [ Time Frame: 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

  6. Number of patients with an improvement in the National Early Warning Score (NEWS) 2 in each treatment arm [ Time Frame: 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

  7. Number of patients with an deterioration in the National Early Warning Score (NEWS) 2 in each treatment arm [ Time Frame: 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

  8. Number of patients requiring Continuous Positive Airway Pressure in each treatment arm [ Time Frame: Day 1 to Day 14 ]
    Details of required respiratory support will be recorded throughout hospitalisation

  9. Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm [ Time Frame: Day 1 to Day 14 ]
    Details of required respiratory support will be recorded throughout the treatment period

  10. Time to patients requiring Continuous Positive Airway Pressure in each treatment arm [ Time Frame: Day 1 to Day 14 ]
    Details of required respiratory support will be recorded throughout the treatment period

  11. Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm [ Time Frame: Day 1 to Day 14 ]
    Details of required respiratory support will be recorded throughout the treatment period

  12. Time to discharge in each treatment arm [ Time Frame: Day 1 to Day 42 ]
    Length of hospital stay will be compared

  13. Number of deaths in each treatment arm [ Time Frame: Day 1 to Day 42 ]
    All cause mortality will be compared


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04363372


Locations
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United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Sponsors and Collaborators
4D pharma plc
Investigators
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Principal Investigator: Dinesh Saralaya, MBBS, MD, MRCP, FRCP Bradford Royal Infirmary
More Information
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Responsible Party: 4D pharma plc
ClinicalTrials.gov Identifier: NCT04363372    
Other Study ID Numbers: MRx-4DP0004-II-001
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 4D pharma plc:
MRx-4DP0004
Coronavirus
Live Biotherapeutic Product
SARS-CoV-2
Immunomodulatory
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases