COVID-19Phase 2NCT04363372
A Study for Efficacy and Safety of Live Biotherapeutic MRx4DP0004 to Treat COVID-19
A Phase 2 study testing MRx-4DP0004 in people with COVID-19, run by 4D pharma plc at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- MRx-4DP0004
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2020to Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Chest X-ray with evidence of COVID-19 e.g. ground-glass opacities
- Requires admission to hospital
- Able to swallow oral capsules
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- COVID-19
- Being tested
- MRx-4DP0004, Placebo
- Keywords
- MRx-4DP0004, Coronavirus, Live Biotherapeutic Product, SARS-CoV-2, Immunomodulatory
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRx-4DP0004Drug
MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
PlaceboDrug
Placebo capsules will be identical in appearance to active product.
| Study group | Role | What they receive |
|---|---|---|
| MRx-4DP0004 | Experimental | 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. Receives: Drug: MRx-4DP0004 |
| Placebo | Placebo comparator | Patients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Day 42
Secondary outcomes (13)
Number of adverse events in each treatment arm
Safety and tolerability will be determined according to clinically relevant reported adverse events
Measured: Baseline to Day 42
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
Measured: Day 1 to Day 42
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
Measured: Day 1 to Day 42
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
Measured: Day 1 to Day 14
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
Measured: Day 1 to Day 14
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
Measured: Day 1 to Day 14
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
Measured: Day 1 to Day 14
Number of patients requiring Continuous Positive Airway Pressure in each treatment arm
Details of required respiratory support will be recorded throughout hospitalisation
Measured: Day 1 to Day 14
Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Measured: Day 1 to Day 14
Time to patients requiring Continuous Positive Airway Pressure in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Measured: Day 1 to Day 14
Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Details of required respiratory support will be recorded throughout the treatment period
Measured: Day 1 to Day 14
Time to discharge in each treatment arm
Length of hospital stay will be compared
Measured: Day 1 to Day 42
Number of deaths in each treatment arm
All cause mortality will be compared
Measured: Day 1 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: Recruitment Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4D pharma plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dinesh Saralaya, MBBS, MD, MRCP, FRCP, Principal investigator, Bradford Royal Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363372
- Sponsor's protocol ID
- MRx-4DP0004-II-001
- Status last verified
- Jun 2020
- First submitted
- 24 Apr 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04363372
- Acronym / sponsor ID
- MRx-4DP0004-II-001
- Conditions
- COVID-19
- Keywords
- MRx-4DP0004, Coronavirus, Live Biotherapeutic Product, SARS-CoV-2, Immunomodulatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment Issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- 4D pharma plcIndustry (pharma, biotech, devices)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRx-4DP0004 | Experimental | Drug: MRx-4DP0004Patients 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients receiving standard of care will also take 2 placebo capsules, twice a day for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to sign the consent form
- Suspected or confirmed COVID-19 as defined by:
- Requires admission to hospital
- Able to swallow oral capsules
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRx-4DP0004MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria. | Drug | MRx-4DP0004 |
| PlaceboPlacebo capsules will be identical in appearance to active product. | Drug | Placebo |
Primary outcome
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
13 secondary outcomes
Number of adverse events in each treatment arm
Time frame: Baseline to Day 42
Number of patients with an improvement in clinical status score in each treatment arm
Time frame: Day 1 to Day 42
Number of patients with a deterioration in clinical status score in each treatment arm
Time frame: Day 1 to Day 42
Number of patients with at least 95% oxygen saturation on room air in each treatment arm
Time frame: Day 1 to Day 14
Time to patients with at least 95% oxygen saturation on room air in each treatment arm
Time frame: Day 1 to Day 14
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
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
Number of patients requiring Continuous Positive Airway Pressure in each treatment arm
Time frame: Day 1 to Day 14
Number of patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Time frame: Day 1 to Day 14
Time to patients requiring Continuous Positive Airway Pressure in each treatment arm
Time frame: Day 1 to Day 14
Time to patients requiring Intermittent Positive Pressure Ventilation in each treatment arm
Time frame: Day 1 to Day 14
Time to discharge in each treatment arm
Time frame: Day 1 to Day 42
Number of deaths in each treatment arm
Time frame: Day 1 to Day 42
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Saralaya, MBBS, MD, MRCP, FRCP principal investigator
Bradford Royal Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MRx-4DP0004 in people with COVID-19, run by 4D pharma plc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean clinical status score in each treatment arm (time frame: Baseline to Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.