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    Summary
    EudraCT Number:2020-001597-30
    Sponsor's Protocol Code Number:MRx-4DP0004-II-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-001597-30
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the effectiveness and safety of bacteria called Bifidobacterium breve in patients with COVID-19 infections
    A.4.1Sponsor's protocol code numberMRx-4DP0004-II-001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsor4D pharma plc
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support4D pharma plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation4D pharma plc
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street Address9 Bond Court
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS1 2JZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440113895 0130
    B.5.6E-mailclinicaltrials@4dpharmaplc.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMRx-4DP0004
    D.3.2Product code MRx-4DP0004
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeBifidobacterium breve
    D.3.9.3Other descriptive nameMRx-4DP0004
    D.3.9.4EV Substance CodeSUB203844
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1E9 to 1E10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptoms of Covid-19 infection
    E.1.1.1Medical condition in easily understood language
    Symptoms of Covid-19 infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10061986
    E.1.2Term SARS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of MRx-4DP0004 on the clinical outcome of participants with COVID-19 symptoms
    E.2.2Secondary objectives of the trial
    To determine the safety of MRx-4DP0004 in participants with COVID-19 symptoms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to sign the informed consent in English and comply with the protocol
    2. Age 18 years or older
    3. Suspected or confirmed COVID-19 as defined by
    a. Positive RNA test for SARS-CoV-2
    OR
    b. Presenting with symptoms of COVID-19 as determined by the investigator, and
    c. A score of 4 or 5 on the WHO Ordinal Scale for Clinical Improvement, and
    d. Oxygen saturation of <95% on room air, and
    e. Chest x-ray with evidence of COVID-19 infection e.g. ground-glass opacities
    Up to 2 repeat RNA tests at 2-day intervals may be performed. Participants will be withdrawn from treatment unless at least 1 of 3 RNA tests is positive
    4. Requires admission to hospital
    5. Able to swallow oral capsules
    E.4Principal exclusion criteria
    1. Known valvular heart defects, pulmonary hypertension or heart failure
    2. Known cystic fibrosis or chronic obstructive pulmonary disease
    3. Known GI fistula or malabsorption syndrome
    4. Known allergy to ALL of the following antibiotics: ampicillin AND clindamycin AND imipenem
    5. Any other condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the study endpoints
    6. Participants requiring prophylactic antibiotic treatment or antibiotics for a pre-existing condition at enrolment or within the 2 days prior to start of study treatment
    7. Females who are pregnant or breastfeeding or planning to become pregnant during the study or for 30 days after completion of study treatment
    8. Unwilling or unable to follow contraceptive requirements as described in section 4.3.2
    9. Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to start of study treatment
    E.5 End points
    E.5.1Primary end point(s)
    Change in mean clinical status score as measured by the WHO Ordinal Scale for Clinical Improvement
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the trial
    E.5.2Secondary end point(s)
    • Safety and tolerability as measured by adverse events and serious adverse events
    • Number of participants with a decrease in score of 1, 2 and >2 points on the WHO Ordinal Scale for Clinical Improvement
    • Number of participants with an increase in score of 1, 2 and >2 points on the WHO Ordinal Scale for Clinical Improvement
    • Number of participants who have >= 95% oxygen saturation on room air after 14 days of therapy
    • Time from starting therapy to participants having >= 95% oxygen saturation on room air
    • Number of participants with an improvement in their risk classification on the National Early Warning Score (NEWS) 2
    • Number of participants having a detrimental change in their risk classification on the National Early Warning Score (NEWS) 2
    • Number of participants developing a disease state requiring CPAP
    • Number of participants developing a disease state requiring IPPV
    • Time from starting therapy to participants requiring CPAP
    • Time from starting therapy to participants requiring IPPV
    • Time to discharge
    • Number of participant deaths
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Ireland
    Italy
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Routine clinical care will be provided in parallel with study participation. After completion of the study, care will continue for each subject as normal.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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