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    Summary
    EudraCT Number:2020-001406-27
    Sponsor's Protocol Code Number:RECHMPL20-168
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001406-27
    A.3Full title of the trial
    Randomized open label trial assessing efficacy and safety of hydroxychloroquine plus azithromycin versus hydroxychloroquine for hospitalized patients with COVID-19
    Etude multicentrique, randomisée, de l’efficacité et la sécurité de la Bithérapie Hydroxychloroquine + Azithromycine comparée à une Monothérapie par Hydroxychloroquine chez des adultes hospitalisés pour une infection COVID-19 avec une pneumonie non réanimatoire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    efficacy and safety of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine in adult patients with documentated infection by covid19
    A.4.1Sponsor's protocol code numberRECHMPL20-168
    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 Hospital of Montpellier
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity hospital of Montpellier
    B.5.2Functional name of contact pointClaire CHAUVETON
    B.5.3 Address:
    B.5.3.1Street Address191 avenue du Doyen Gaston Giraud
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number00330608492834
    B.5.5Fax number0033467339172
    B.5.6E-maildepotAC@chu-montpellier.fr
    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
    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.3.4Pharmaceutical 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.3.9.3Other 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.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 azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz
    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.3.1Product nameazithromycine
    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 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
    infection COVID 19
    E.1.1.1Medical condition in easily understood language
    infection COVID 19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of efficacy of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine administered for 10 days, on patient infected with SarS COV 2 with either a moderate clinical form (level 3), or a severe non-resuscitative clinical form (level 4)
    Evaluer l’efficacité d’une bithérapie hydroxychloroquine-azithromycine administrée pendant 10 jours, comparativement à l’hydroxychloroquine seule, sur l’amélioration clinique à J11 d’au moins un niveau selon une échelle ordinale (échelle utilisée dans l’essai Discovery NCT04315948), chez des adultes hospitalisés pour une infection COVID-19 de gravité moyenne (hospitalisation sans oxygénothérapie : niveau 3) ou sévère (hospitalisation avec oxygénothérapie hors réanimation : niveau 4)
    E.2.2Secondary objectives of the trial
    - Evaluation of the safety of a bitherapy by hydroxychloroquine + azythromycin vs monotherapy by hydroxychoroquine
    - Need of oxygenotherapy
    - virological, and pharmacokinetic assessment of each treatment
    -PAtient transfer in ICU.
    - hospitalization duration
    Vital status
    Adverses event
    Efficacité clinique
    Evolution (amélioration, stabilité, progression) de l’état clinique sur échelle 7 niveaux à J3, J5, J8, J11, J 15 et J29
    Evolution du Score NEWS à J3, J5, J8, J11, J 15 et J29
    Evolution variables physiologiques (température, fréquence respiratoire)
    Evolution des images radiologiques pulmonaires entre J1 et J11
    Nécessité et durée oxygénothérapie
    Nécessité de transfert en réanimation
    Nécessité ventilation mécanique
    Durée hospitalisation (jours)
    Mortalité hospitalière et à J29
    Sécurité et tolérance
    Incidence des événements indésirables sérieux
    Incidence des événements rattachés aux traitements
    Incidence des anomalies biologiques
    Evolution de l’espace QTc en cours de traitement (ECG de surveillance à J2, J3, J5, J8 J11)
    Arrêt prématuré des traitements de l’étude
    Evaluation virologique (PCR qualitative et quantitative) et immunologique à J5, J10, J15
    Evaluation pharmacocinétique à J3, J8 et J11
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    immunological assessment of the effect of the experimental treatment (only in Montpellier Hospital)
    E.3Principal inclusion criteria
    Written informed consent
    Adult under 75 years old
    - documented infection with SARS CoV 2 (positive virological test) within 96 h before randomization
    - COVID-19 symptoms occurring within 10 days of randomization
    - Radiographic or tomography signs of pneumonia (infiltrates)
    - Hospitalized patient (outside the intensive care unit) with either a moderate clinical form (defined as not requiring oxygen therapy at the time of randomization), or a severe non-resuscitative clinical form (defined as requiring oxygen therapy by nasal tube or mask with an oxygen flow <6 l / min)
    - Etre capable de, et être disposé(e) à fournir un consentement éclairé écrit avant la réalisation des procédures de l’étendue
    - Age d’au moins 18 ans et de 75 ans au plus
    - Infection par le SARS-CoV-2, documentée par un test virologique positif dans les 96 h précédent la randomisation
    - Début des symptômes de COVID-19 datant de moins de 10 jours au moment de la randomisation
    - Présence de symptôme(s) de COVID-19 : fièvre (température  37,5°C) ou signe(s) respiratoires (toux, gêne respiratoire) ou anosmie récente (perte de l’odorat)
    - Présence de signes radiographiques ou tomodensitométriques de pneumonie (infiltrats)
    - Hospitalisation hors unité de réanimation pour un COVID-19 avec soit une forme clinique modérée (définie comme ne nécessitant pas au moment de la randomisation une oxygénothérapie), soit une forme clinique sévère non réanimatoire ( définie comme nécessitant une oxygénothérapie par sonde nasale ou masque avec un débit d’oxygène < 6 l/min)
    E.4Principal exclusion criteria
    -- admission to intensive care at the time of selection
    - contraindication to IMPs
    Oxygen saturation rate low defined as
    - <90% in ambient air
    - <94% with oxygen therapy  3 l / min
    need for oxygen therapy≥ 6 l / min or mechanical ventilation
    ALT or ASAT rate> 5 LSN
    renal failure (DGFe <30 ml / min) or dialysis
    Pregnancy or breastfeeding
    Retinopathy
    Known G6PD deficiency
    History of heart rhythm disorder or QT prolongation
    Prolongation of the QT space on an ECG dating at the time of selection of less than 24 hours: QTc> 450 ms
    - hydoxychloroquine contra indication (citalopram, escitalopram, hydroxyzine, domperidone and piperaquine);
    - Taking drugs known to prolong the QT interval or likely to induce a cardiac arrhythmia such as anti-arrhythmics of class IA and III, tricyclic antidepressants, antipsychotics
    - Participation in another clinical trial with an experimental treatment of COVID-19
    - A Concomitant treatment with possible action on SARS-CoV-2 is not authorized if it is administered less than 24 hours before the administration of the IMP
    Les patient(e)s qui remplissent l’un des critères suivants ne doivent être inclus dans l’étude :
    Taux de saturation en oxygène (SaO2 par gazométrie artérielle ou SpO2 par saturomètre-oxymètre de pouls) bas défini comme
    < 90 % en air ambiant
    < 94 % avec une oxygénothérapie  3 l/min
    Nécessité d’une oxygénothérapie ≥ 6 l/min ou d’une ventilation mécanique
    Nécessité d’une admission en réanimation au moment de la sélection
    Anticipation d’un séjour dans un service hospitalier ne participant pas à l’essai dans un délai inférieur à 3 jours
    Taux d’ALAT ou d’ASAT > 5 LSN
    insuffisance rénale (DGFe < 30 ml/min ) ou dialyse
    Grossesse ou allaitement
    Rétinopathie
    Déficit connu en G6PD
    Antécédents de troubles du rythme cardiaque ou d’allongement QT
    Allongement de l’espace QT sur un ECG datant au moment de la sélection de moins de 24h: QTc > 450 ms
    Prise de médicaments contre-indiqués avec la prise d’hydoxychloroquine (citalopram, escitalopram, hydroxyzine, la dompéridone et la pipéraquine) ;
    Prise de médicaments connus pour allonger l'intervalle QT ou susceptibles d'induire une arythmie cardiaque comme par exemple les anti-arythmiques de classe IA et III, les antidépresseurs tricycliques, les antipsychotiques
    Participation à un autre essai clinique portant sur un traitement expérimental du COVID-19
    Prise d'un autre traitement ayant une action possible sur le SARS-CoV-2 dans les 24 h avant la randomisation
    E.5 End points
    E.5.1Primary end point(s)
    At least 1 level improvement in clinical status assessed by a level ordinal scale (at least 1 level) between D1 and D11 :
    1. Not hospitalized, no limitation of activities
    2. Not hospitalized, limitation of activities;
    3. Hospitalized, not requiring oxygen supplementation
    4. Hospitalized, requiring oxygen supplementation
    5. Hospitalized, non-invasive ventilation or high flow oxygen device
    6. Hospitalized, under invasive mechanical ventilation or ECMO (extracorporeal membrane oxygenation)
    7. Death
    temps jusqu’à l’amélioration clinique d’au moins un niveau selon une échelle ordinale à partir de J1 (jour de la première administration des médicaments de l’étude) jusqu’à J11 (lendemain du dernier jour du traitement).
    1. Non hospitalisé, aucune limitation des activités
    2. Non hospitalisé, limitation des activités;
    3. Hospitalisé, ne nécessitant pas de supplémentation en oxygène
    4. Hospitalisé, nécessitant une supplémentation en oxygène
    5. Hospitalisé, sous ventilation non invasive ou dispositif à oxygène haut débit
    6. Hospitalisé, sous ventilation mécanique invasive ou ECMO
    7. Mort
    E.5.1.1Timepoint(s) of evaluation of this end point
    D11
    E.5.2Secondary end point(s)
    1.clinical status
    2.variation of clinical and respiratory parameter
    3.Adverse event
    4.Virological (qualitative and quantitative PCR) and immunological evaluation at D5, D10, D15
    5.pharmacokinetic evaluation at D3 D5 D8 and D11
    6. oxygenotherapy duration
    7. Hospitalization duration
    8 mortality
    9. ICU transfer
    10 QTc prolongation
    11.Variation of pulmonary CT images between D1 and D11, with centralized blind analysis by independent expert reader
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Day 3, 5,7, 11, 15, 29
    2. up to Day 29
    3. up to Day 29
    4. Day 5, D10 and D15
    5. D3 D5 D8 and D11
    6. up to D15
    8. up to D 29
    9. up to D29
    10. D2, D3 D5, D8, D11
    11 D11
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    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 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 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
    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 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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state120
    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 Decision2020-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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