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    Summary
    EudraCT Number:2020-003486-19
    Sponsor's Protocol Code Number:1.002.20
    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:2020-08-14
    Trial 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 number2020-003486-19
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled trial of SFX-01 or placebo on a backbone of best standard care, to improve outcomes in patients with community acquired pneumonia and suspected or confirmed SARS-CoV-2 infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SFX-01 treatment for Acute Respiratory Infections (STAR-Covid19)
    A.3.2Name or abbreviated title of the trial where available
    SFX-01 treatment for Acute Respiratory Infections (STAR-Covid19)
    A.4.1Sponsor's protocol code number1.002.20
    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 SponsorUniversity of Dundee
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLifeArc
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportEvgen Pharma plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Dundee
    B.5.2Functional name of contact pointJames Chalmers
    B.5.3 Address:
    B.5.3.1Street AddressNinewells Hospital, Level 5 Mailbox 12
    B.5.3.2Town/ cityDundee
    B.5.3.3Post codeDD1 9SY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01382383642
    B.5.6E-mailj.chalmers@dundee.ac.uk
    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 nameSulforadex
    D.3.2Product code SFX-01
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulforadex
    D.3.9.1CAS number 1039704-32-9
    D.3.9.2Current sponsor codeSFX-01
    D.3.9.3Other descriptive nameSulforaphane/α-Cyclodextrin complex
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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, hard
    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
    Community acquired pneumonia with suspected or confirmed SARS-CoV-2 infection
    E.1.1.1Medical condition in easily understood language
    Pneumonia lung disease
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066724
    E.1.2Term Acute pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084380
    E.1.2Term COVID-19 pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effectiveness of a new drug, SFX-01, against placebo for treating patients with suspected COVID19 respiratory infection.
    E.2.2Secondary objectives of the trial
    To measure the safety of the new drug, SFX-01, when used to treat patients with suspected COVID19 respiratory infection.

    To explore the mechanism by which the new drug is having its effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 18 years of age or older
    • Community acquired pneumonia (defined as a new radiographic infiltrate on chest x-ray or CT scan in a patient presenting with respiratory symptoms both of which are clinically evident less than 48 hours after hospitalization).
    • Tested for suspected SARS-CoV-2 infection via RT-PCR or another approved laboratory method*
    • Increased risk of mortality on admission (defined by CURB65 score greater than or equal to 1 or the presence of bilateral radiographic infiltrates)
    • Treatment can be commenced within 96 hours of hospital admission
    • Requires hospitalisation but NOT requiring mechanical ventilation at randomization
    • Participant (or legally authorized representative) provides written informed consent
    • Able to take oral medication at randomisation
    • Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures.

    *for the avoidance of doubt, this trial permits inclusion of patients presenting with acute respiratory infections whether or not the test for SARS-CoV-2 is positive. Patients can be randomised to the study while awaiting the results of the test for SARS-CoV-2.
    E.4Principal exclusion criteria
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available).
    • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR less than 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available)
    • Pregnant or breast feeding.
    • Anticipated transfer to another hospital which is not a trial site within 24 hours.
    • Hospital-acquired pneumonia (defined as onset of respiratory illness more than 48 hours after admission to hospital)
    • Allergy to SFX-01
    • Patients in whom active treatment is not considered appropriate.
    • Use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical status on 7-point ordinal scale:
    1. Not hospitalised, no limitations on activities
    2. Not hospitalised, limitation on activities;
    3. Hospitalised, not requiring supplemental oxygen;
    4. Hospitalised, requiring supplemental oxygen;
    5. Hospitalised, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalised, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)
    7. Death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15 (where day 1 is the first day of treatment)
    E.5.2Secondary end point(s)
    Clinical Severity;
    Time to an improvement of one category from admission using 7-point ordinal scale. Daily whilst hospitalised
    Participant clinical status on 7-point ordinal scale. Days 3, 5, 8, 11, 15 and 29.
    Participant change from baseline on 7-point ordinal scale. Day 15.
    Proportion of participants showing improvement on 7-point ordinal scale. Day 15.
    Mean change in the 7-point ordinal scale. Baseline to days 3, 5, 8, 11, 15 and 29

    NEWS;
    Time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first
    Change from baseline Days 8, 15, 29

    Oxygenation;
    Oxygen free days 0-29 days
    Incidence and duration of new oxygen use during the trial 0-29 days

    Mechanical Ventilation:
    Ventilator free days 0-29 days
    Incidence and duration of new mechanical ventilation use during the trial 0-29 days.

    Duration of hospitalisation; date of admission and discharge

    15day and 28day mortality; date of death

    Cumulative incidence of serious Adverse events (SAEs) 0-29 days

    Discontinuation or temporary suspension of treatment 0-29 days
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    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 No
    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.8.3 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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    last day 29 for last participant
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    As the trial 14 day treatment is for for an acute illness it would not be
    appropriate for participants to continue to receive their trial treatment after the end of the trial.
    Trial treatment will not be made available to participants at the end of the trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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