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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001265-36
    Sponsor's Protocol Code Number:UCDCRC/20/01
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-07
    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 ConcernedIreland - HPRA
    A.2EudraCT number2020-001265-36
    A.3Full title of the trial
    A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non-critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare standard of care (SOC) alone with SOC plus hydroxychloroquine or SOC with a combination of hydroxycholorquine and azithromysin in the treatment of coronovirus
    A.4.1Sponsor's protocol code numberUCDCRC/20/01
    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 College Dublin
    B.1.3.4CountryIreland
    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 supportUniversity College Dublin
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointQRAM
    B.5.3 Address:
    B.5.3.1Street AddressBelfield
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeDublin 4
    B.5.3.4CountryIreland
    B.5.6E-mailcrc.monitoring@ucd.ie
    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-aventis Ireland Limited T/A SANOFI
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 namePlaquenil
    D.3.4Pharmaceutical form Film-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 sulfate
    D.3.9.1CAS number 118-42-3
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULPHATE BP
    D.3.9.4EV Substance CodeSUB177997
    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.IMP: 2
    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 Azromax
    D.2.1.1.2Name of the Marketing Authorisation holderClonmel Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Film-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 INNAzithromycin
    D.3.9.1CAS number 121470-24-4
    D.3.9.3Other descriptive nameAZITHROMYCIN MONOHYDRATE
    D.3.9.4EV Substance CodeSUB87696
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    SARS-CoV-2 PCR-positive population
    E.1.1.1Medical condition in easily understood language
    COVID-19 positive
    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 PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    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 efficacy of azithromycin monotherapy, hydroxychloroquine monotherapy or a combination of hydroxychloroquine and azithromycin as potential therapies in a non-critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of progressive clinical decline.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Documented Covid-19 positive
    • Evidence of progressive clinical decline:
    o Rising inflammatory markers over a 24 hour period (increases in CRP, d-dimer, LDH and/or ferritin above the upper limit of normal)
    o Presence of or progression of pulmonary infiltrates on CXR (as decided by the treating physician)
    o New hypoxia requiring >2l/min/28% FiO2 to maintain oxygen saturations ≥94% (or 88-92% in patients with chronic hypercapnic respiratory failure)
    E.4Principal exclusion criteria
    • Pregnant or breastfeeding woman
    • Known hypersensitivity to chloroquine or hydroxy chloroquine or any excipients
    • Known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics or any of the excipients
    • Known deficit in G6PD
    • Known retinopathy
    • Patient with history of cardiac arrythmia related to QT prolongation
    • Suspected acute cardiogenic pulmonary oedema at the time of enrolment
    • QTc >500ms on two consecutive ECG measurements at screening
    • Hypokalaemia (<3.0mmol/L) or hyperkalaemia (>6.1mmol/L) at screening
    • Hypocalcaemia (<2.1mmol/L) or hypercalcaemia (>2.6mmol/L) (corrected for albumin) at screening
    • Subjects receiving medications with a significant QT prolongation potential (if these treatments cannot be discontinued)
    E.5 End points
    E.5.1Primary end point(s)
    Composite primary endpoint is time to progression to intubation, non-invasive ventilation or death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to event
    E.5.2Secondary end point(s)
    1. All-cause mortality at 14, 30 and 60 days
    2. Time to clearance of COVID19 from nasopharyngeal pathway (PCR)
    3. Change in inflammatory markers at day 7, 14 and 30
    4. Change in supplemental oxygen requirements at day 7, 14 and 30
    5. Length of stay in ICU
    6. Time from intubation to extubation
    7. Progression to moderate to severe respiratory failure as defined by PaO2/FiO2≤200mmHg and PEEP ≥5cmH2O
    8. Time to discharge from hospital
    9. Change/normalisation of A-a gradient
    10. Resolution of radiological infiltrates
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. All-cause mortality at 14, 30 and 60 days
    2. Time to clearance of COVID19 from nasopharyngeal pathway (PCR) - up to 60 days
    3. Change in inflammatory markers at day 7, 14 and 30
    4. Change in supplemental oxygen requirements at day 7, 14 and 30
    5. Length of stay in ICU (within 60 day study duration)
    6. Time from intubation to extubation (time to event - within study duration)
    7. Progression to moderate to severe respiratory failure as defined by PaO2/FiO2≤200mmHg and PEEP ≥5cmH2O (time to event, within study duration)
    8. Time to discharge from hospital (time to event within study duration)
    9. Change/normalisation of A-a gradient (time to event within study duration)
    10. Resolution of radiological infiltrates (within 60 day study duration)
    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 No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 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
    Complete follow-up of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months0
    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: 161
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state267
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 267
    F.4.2.2In the whole clinical trial 267
    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 Decision2020-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-07-23
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