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

COVID-19 Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04363372
• Other study ID #: MRx-4DP0004-II-001
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 2020
• Est. completion date: January 2021

Study information

• Verified date: June 2020
• Source: 4D pharma plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• MRx-4DP0004
MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
• Placebo
Placebo capsules will be identical in appearance to active product.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
4D pharma plc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to Day 42
Secondary	Number of adverse events in each treatment arm	Safety and tolerability will be determined according to clinically relevant reported adverse events	Baseline to Day 42
Secondary	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	Day 1 to Day 42
Secondary	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	Day 1 to Day 42
Secondary	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	Day 1 to Day 14
Secondary	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	Day 1 to Day 14
Secondary	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	Day 1 to Day 14
Secondary	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	Day 1 to Day 14
Secondary	Number of patients requiring Continuous Positive Airway Pressure in each treatment arm	Details of required respiratory support will be recorded throughout hospitalisation	Day 1 to Day 14
Secondary	Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm	Details of required respiratory support will be recorded throughout the treatment period	Day 1 to Day 14
Secondary	Time to patients requiring Continuous Positive Airway Pressure in each treatment arm	Details of required respiratory support will be recorded throughout the treatment period	Day 1 to Day 14
Secondary	Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm	Details of required respiratory support will be recorded throughout the treatment period	Day 1 to Day 14
Secondary	Time to discharge in each treatment arm	Length of hospital stay will be compared	Day 1 to Day 42
Secondary	Number of deaths in each treatment arm	All cause mortality will be compared	Day 1 to Day 42