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    Summary
    EudraCT Number:2020-001643-13
    Sponsor's Protocol Code Number:01.01.20
    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:2020-04-29
    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 number2020-001643-13
    A.3Full title of the trial
    A randomised double-blind placebo-controlled trial of Brensocatib (INS1007) in patients with severe COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised double-blind placebo-controlled trial of Brensocatib (INS1007) in patients with severe COVID-19
    A.3.2Name or abbreviated title of the trial where available
    STOP-COVID19: Superiority Trial Of Protease inhibition in COVID-19
    A.4.1Sponsor's protocol code number01.01.20
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN30564012
    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.1.3.4Country
    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 supportInsmed Inc
    B.4.2CountryUnited States
    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 AddressDivision of Cardiovascular & Diabetes Medicine
    B.5.3.2Town/ cityLevel 5, Mailbox 12
    B.5.3.3Post codeDD1 9SY
    B.5.4Telephone number01382 383642
    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 nameBrensocatib
    D.3.2Product code INS1007
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrensocatib
    D.3.9.1CAS number 1802148-05-5
    D.3.9.2Current sponsor codeINS1007
    D.3.9.3Other descriptive nameAZD7986
    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 number25
    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 placeboFilm-coated tablet
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of the study is to evaluate the clinical efficacy of Brensocatib compared to placebo on top of standard care in adult patients hospitalized with COVID-19
    E.2.2Secondary objectives of the trial
    Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm
    Quality of life
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The following will be carried out at the Tayside site only.
    Exploratory assessment- viral shedding
    Where practical in a substudy at the Tayside site only, nasal swabs will be obtained on day 15 and day 29 to evaluate viral clearance by PCR.
    Exploratory assessment- neutrophil studies
    In a substudy at the Tayside site only, additional blood will be taken for isolation of peripheral blood neutrophils to examine neutrophil serine protease activity.
    E.3Principal inclusion criteria
    • Male or female
    • ≥16 years of age
    • SARS-CoV-2infection (clinically suspected+ or laboratory confirmed*).
    • Admitted to hospital as in-patient less than 96 hours prior to randomisation^
    • Illness of any duration, and at least one of the following:
    o Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan)
    OR
    o Evidence of rales/crackles on physical examination
    OR
    o Peripheral capillary oxygen saturation (SpO2) ≤94% on room air prior to randomization
    OR
    o Requiring supplemental oxygen.
    OR
    o Lymphocyte count <1 x 109 cells per litre (L)
    • Participant (or legally authorized representative) provides written informed consent
    • Able to take oral medication
    • Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures.
    *Laboratory-confirmed: SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 96 hours prior to randomization.
    +Clinically suspected: in general, SARS-CoV-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest X-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). However, the diagnosis remains a clinical one based on the opinion of the managing doctor
    ^Where a patient has been admitted to hospital for a non COVID-19 reason and develops COVID-19 symptoms whilst an in-patient, randomisation my occur up to 96 hours from onset of symptoms.
    E.4Principal exclusion criteria
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 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).
    • History of severe liver disease
    • Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available)
    • Absolute neutrophil count less than 1.0 x 109 cells per L within 72 hours of randomization (the result closest to randomization should be used if several results are available)
    • Current treatment with potent Cyp3A4 inducers/inhibitors (e.g Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin)
    • HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors*
    • Pregnant or breast feeding.
    • Anticipated transfer to another hospital which is not a trial site within 24 hours.
    • Allergy to Brensocatib
    • 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. Co-enrolment with COVID-19 trials is allowed as per co-enrolment agreements and/or individual decision by the CI.
    Women of child-bearing potential must be willing to have pregnancy testing prior to trial entry.
    *The Liverpool HIV checker (https://www.hiv-druginteractions.org/checker) should be used to check for any HIV drug interactions. Simvastatin could be used as a surrogate for Brensocatib as it metabolised similarly by CYP 3A4 pathway.

    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
    Up to day 29
    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.
    Mean change in the 7-point ordinal scale Baseline to days 3, 5, 8, 11, 15 and 29.

    National Early Warning Score (NEWS):
    Time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Daily whilst in hospital.
    Change from baseline Days 8, 15, 29

    Oxygenation:
    Oxygen free days 1-29 days
    Incidence and duration of new oxygen use during the trial 1-29 days

    Mechanical Ventilation:
    Ventilator free days 1-29 days
    Incidence and duration of new mechanical ventilation use during the trial. 1-29 days

    Hospitalisation:
    Duration of hospitalisation (days). Date of admission and discharge

    Mortality:
    28-day mortality Date of death

    Cumulative incidence of serious Adverse events (SAEs) 1-29 days
    Discontinuation or temporary suspension of treatment 1-29 days
    Changes in white cell count, haemoglobin, platelets, creatinine, total bilirubin, ALT, and AST over time (hospitalised participants only) Days 0/1, 3, 5, 8, 11, 15, 29
    Adverse events of special interest- hyperkeratosis, infections and dental complications 1-29 days

    EQ-5D-5L administered via telephone (if at home) or in person if still in hospital Day 29






    E.5.2.1Timepoint(s) of evaluation of this end point
    As 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number 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 concerned15
    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 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
    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 months0
    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 days20
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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 treatment an acute treatment for a 28 day treatment period only 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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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