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    Summary
    EudraCT Number:2020-001417-21
    Sponsor's Protocol Code Number:ITM202004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-01
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001417-21
    A.3Full title of the trial
    An open label single center randomized controlled trial to evaluate the effect of hydroxychloroquine on viral shedding in mild COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open label single center randomized controlled trial to evaluate the effect of hydroxychloroquine on viral shedding in mild COVID-19
    A.3.2Name or abbreviated title of the trial where available
    COVIDAM
    A.4.1Sponsor's protocol code numberITM202004
    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 SponsorInstitute of Tropical Medicine
    B.1.3.4CountryBelgium
    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 supportInstitute of Tropical Medicine
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITM Clinical Trial Unit
    B.5.2Functional name of contact pointYven Van Herrewege
    B.5.3 Address:
    B.5.3.1Street AddressNationalestraat 155
    B.5.3.2Town/ cityAntwerp
    B.5.3.4CountryBelgium
    B.5.6E-mailyvanherrewege@itg.be
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical form Coated 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.3.8INN - Proposed INNHYDROXYCHLOROQUINE
    D.3.9.1CAS number 747-36-4
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 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 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10047438
    E.1.2Term Viral infectious disorders
    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
    To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative nasopharyngeal RT-PCR for SARS-CoV-2 by day 7 post diagnosis in the HC arm compared to the no-HC arm.
    E.2.2Secondary objectives of the trial
    Secondary objective 1: To assess the safety of HC in COVID-19 patients treated in the ambulatory setting
    Secondary objective 2: To assess the clinical efficacy of HC in COVID-19 patients
    Secondary endpoint 3:To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative COVIDAM, Protocol version 3.0, dated 16/April/2020 9/49
    nasopharyngeal RT-PCR for SARS-CoV-2 by day 7 post onset of symptoms (POS) in the HC arm compared to the no-HC arm.
    Secondary Objective 4: To assess if 10 doses of HC, each taken 12 hours apart, increase the proportion of COVID-19 patients who have a negative nasal AND salivary RT-PCR for SARS-CoV-2 by day 7 post diagnosis in the HC arm compared to the no-HC arm.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 18 and < 65 years old
    - Confirmed symptomatic or asymptomatic COVID-19 as defined by a laboratory diagnosis of SARS-CoV-2 on a respiratory sample within the previous 72 hours
    - If symptomatic, having COVID-19 symptoms since less than 72 hours (cough, throat ache, fever, dyspnea) at the time of enrollment.
    - Able and willing to provide written informed consent.
    - Able to safely attend, with individual transportation, scheduled follow-up visits at ITM.
    E.4Principal exclusion criteria
    - Need of hospitalization before or at enrollment visit (visit 1)
    - Known contra-indication to HC (hypersensitivity to 4-aminoquinoline compounds, ocular retinopathy, epilepsy, diabetes)
    - Pregnancy or breast-feeding
    - Use of any other (experimental) drug aiming to treat COVID-19
    - Use of any treatment with potential interaction with HC and flagged “red” or “orange” in the list of drug interactions published on the reference website http://www.covid19-druginteractions.org/ (accessed on 30/03/2020). This is a dynamic list which is being updated as new information becomes available. The most recent update of the list will be used. Antacids are flagged orange but can be used if taken at least 4h before or 4h after HC.
    E.5 End points
    E.5.1Primary end point(s)
    proportion of participants with a negative nasopharyngeal sample* by day 7 post diagnosis
    * defined by a negative RT-PCR on a nasopharyngeal swab of two subsequent study visits. The date of the first negative sample will then be taken as the date of negativity
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 post diagnosis
    E.5.2Secondary end point(s)
    Secondary endpoint 1: frequency and pattern of reported adverse events, adverse reactions, Serious Adverse Events, Serious adverse reactions, and SUSARs..
    Secondary endpoint 2: pattern and duration of clinical symptoms, as reported by the patients; rate of hospital admission during follow-up.
    Secondary endpoint 3: proportion of participants with a negative nasopharyngeal sample* by day 7 POS
    * defined by a negative RT-PCR on a nasopharyngeal swab of two subsequent study visits. The date of the first negative sample will then be taken as the date of negativity
    Secondary endpoint 4: proportion of participants with a negative nasal swab + saliva sample* by day 7 post diagnosis
    * defined by a negative RT-PCR on a self-taken nasal swab AND saliva sample of two subsequent study visits. The date of the first pair of negative samples will then be taken as the date of negativity
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint 1: visit 2 (day 3), visit 3 (day 6), visit 4 (day 9), visit 5 (day 13) ,visit 6 (day 17) and visit 7 (day 21)
    Secondary endpoint 2: visit 2 (day 3), visit 3 (day 6), visit 4 (day 9), visit 5 (day 13) ,visit 6 (day 17) and visit 7 (day 21)
    Secondary endpoint 3: Day 7 Post onset of symptoms
    Secondary endpoint 4: Day 7 post diagnosis
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    symptomatic care only
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LPLV
    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 months5
    E.8.9.1In the Member State concerned days
    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: 206
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-01. Yes
    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 state206
    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)
    Standard of care
    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 Decision2020-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-26
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