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    Summary
    EudraCT Number:2020-001270-29
    Sponsor's Protocol Code Number:EFC16858
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-03-30
    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 number2020-001270-29
    A.3Full title of the trial
    An adaptive Phase 2/3, randomized, open-label study assessing efficacy and safety of hydroxychloroquine for hospitalized patients with moderate to severe COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hydroxychloroquine for COVID 19 in moderately to severely ill hospitalized patients
    A.4.1Sponsor's protocol code numberEFC16858
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-6096
    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 Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis recherche & développement
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street Address410 Thames Valley Park Drive
    B.5.3.2Town/ cityReading
    B.5.3.3Post codeRG6 1PT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+448450230441
    B.5.6E-mailuk-medicalinformation@sanofi.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 Yes
    D.2.1.1.1Trade name PLAQUENIL 200 mg, comprimé pelliculé
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.2Product code SAR390530
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 747-36-4
    D.3.9.2Current sponsor codeSAR321068
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Coronavirus infection
    E.1.1.1Medical condition in easily understood language
    Coronavirus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus 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
    Evaluate the effect of hydroxychloroquine (HCQ) + standard of care as compared to standard of care only on oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) ratio in adult patients hospitalized with moderate to severe Coronavirus Disease 2019 (COVID-19)
    E.2.2Secondary objectives of the trial
    Evaluate the clinical efficacy of HCQ + standard of care as compared to standard of care only in adult patients hospitalized with moderate to severe COVID-19
    Evaluate the effect of HCQ + standard of care as compared to standard of care only on the virologic load in nasopharynx as assessed by quantitative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) counts in adult patients hospitalized with moderate to severe COVID-19
    Evaluate the safety of HCQ + standard of care as compared to standard of care
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must be hospitalized with illness consistent with COVID-19 pneumonia by chest imaging and/or clinical examination and with moderate to severe disease
    Laboratory-confirmed SARS-CoV-2 infection
    Onset of COVID-19 symptoms within 2 weeks before randomization
    Women of childbearing potential must have a negative highly sensitive
    pregnancy test at screening and should agree to use an acceptable
    contraceptive method
    E.4Principal exclusion criteria
    Unlikely to survive for >48 hours from screening
    Participants with critical disease or multi-organ failure
    Any contraindication to HCQ or intolerance to HCQ
    Any medical condition or concomitant therapy that may put the particpants at risk if they are treated with HCQ
    Pregnant or breastfeeding women
    Use of antiarrhythmic medications and medications known to prolong
    QT interval or cause Torsades de Pointes (TdPs)
    Participants with history of congenital or acquired long QT, arrhythmia,
    family history of long QT or sudden cardiac death, or any other cardiac
    condition that, by the judgement of the Investigator, would put the
    patient at higher risk for QTc prolongation or sudden cardiac death
    Participants with the following ECG findings at screening: QTcF >470
    msec for women or >450 msec for men or heart rate <50 beats/minute
    Participants with known glucose-6-phosphate dehydrogenase (G6PD)
    deficiency
    E.5 End points
    E.5.1Primary end point(s)
    1. Phase 2: Change in SpO2/FiO2 ratio from baseline to Day 15.
    2. Phase 3 (may be reassessed after review of phase 2): Change in SpO2/FiO2 ratio from baseline to Day 15
    E.5.1.1Timepoint(s) of evaluation of this end point
    1, 2. Baseline to Day 15
    E.5.2Secondary end point(s)
    1. Phase 2 and Phase 3 (may be adapted for phase 3 based on phase 2 results): Change in SpO2/FiO2 ratio from baseline at Day 30.
    2. Time to resolution of fever, defined as body temperature ≤36.6°C (axilla), or ≤37.2°C (oral), or ≤37.8°C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, whichever is sooner.
    3. Percentage of patients reporting each severity rating on the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status.Score range 1-7 . Lower scale is worse.
    4. Change from baseline in the 7-point ordinal scale score. The ordinal scale is an assessment of the clinical status. Score range 1-7 . Lower scale is worse.
    5. Quantitative SARS-CoV-2 virus in the nasopharyngeal (NP) sample.
    6. Percentage of patients with SARS-CoV-2 detectable in NP samples.
    7. Number of participants with severe adverse events and adverse events leading to treatment or study discontinuation.
    8. Number of particpants with serios adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline to Day 30
    2. Baseline to Day 30
    3. Day 15 and Day 30
    4. Day 15 and Day 30
    5. Day 1,2,5,10, 15
    6. Day 2,5,10
    7. Baseline to Day 30
    8. Baseline to Day 30
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    legally acceptable representative may provide informed consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 350
    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)
    None
    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 Decision2020-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-25
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