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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001373-70
    Sponsor's Protocol Code Number:ET20-076
    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:2020-03-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001373-70
    A.3Full title of the trial
    IMMUNONCOVID-20 : A prospective, controlled, randomized, multicenter study to compare the efficacy of a chloroquine analog (GNS561), anti PD-1 (nivolumab) and anti-interleukine-6 receptor (tocilizumab) versus standard of care in advanced or metastatic cancer patients with SARS-CoV-2 (COVID-19) infection

    IMMUNONCOVID-20 - Etude prospective, contrôlée, randomisée, multicentrique comparant l’efficacité d’un analogue de la chloroquine (GNS561), d’une immunothérapie par anti-PD1 (nivolumab) et d’un anti-interleukine-6R (tocilizumab) par rapport à la prise en charge standard chez des patients atteints de cancer avancé ou métastatique et présentant une infection au SARS-CoV-2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing the efficacy of a chloroquine analog (GNS561), anti PD-1 (nivolumab) and anti-interleukine-6 receptor (tocilizumab) versus standard of care in advanced or metastatic cancer patients with SARS-CoV-2 (COVID-19) infection
    Etude comparant l’efficacité d’un analogue de la chloroquine (GNS561), d’une l’immunothérapie par anti-PD1 (nivolumab) et de l’anti-interleukine-6R (tocilizumab) par rapport à la prise en charge standard chez des patients atteints de cancer avancé ou métastatique et présentant une infection au SARS-CoV-2 (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    IMMUNONCOVID-20
    IMMUNONCOVID-20
    A.4.1Sponsor's protocol code numberET20-076
    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 SponsorCentre Léon Bérard
    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 supportGenoscience Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointJulien GAUTIER
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69373
    B.5.3.4CountryFrance
    B.5.4Telephone number+33426 55 68 29
    B.5.5Fax number+33478 78 27 15
    B.5.6E-mailjulien.gautier@lyon.unicancer.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 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 nameGNS561
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot available
    D.3.9.1CAS number 1914148-72-3
    D.3.9.2Current sponsor codeGNS561
    D.3.9.4EV Substance CodeSUB192575
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 - 200
    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 Opdivo
    D.2.1.1.2Name of the Marketing Authorisation holderBristol Myers Squibb
    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 nameNivolumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number NIVOLUMAB
    D.3.9.2Current sponsor codeET17-093
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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: 3
    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 nameTocilizumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit
    Patients présentant un cancer avancé ou métastatique atteint d’une infection par le Sars-CoV-2 et non éligible par une prise en charge en réanimation
    E.1.1.1Medical condition in easily understood language
    Patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit
    Patients présentant un cancer avancé ou métastatique atteint d’une infection par le Sars-CoV-2 et non éligible par une prise en charge en réanimation
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The main objective is to compare versus standard of care short-term mortality rates in advanced or metastatic cancer patients who are positive for COVID-19 treated with a chloroquine analog (GNS561), an anti-PD1 (nivolumab) or an anti-IL-6R antibody (tocilizumab).
    L'objectif principal est de comparer versus le traitement standard les taux de mortalité à court terme chez les patients atteints de cancers avancés ou métastatiques diagnostiqués positifs au COVID-19 traités avec un analogue de la chloroquine (GNS561), une immunothérapie (anti-PD1) ou un anticorps anti-IL-6R (tocilizumab).
    E.2.2Secondary objectives of the trial
    The secondary objectives will be to describe in each arm of the study:
    • Time to clinical improvement
    • Clinical status at days 7, 14 and 28
    • Mean change in clinical status from baseline to days 7, 14 and 28
    • Overall survival
    • Length of stay in Intensive Care Unit and in Resuscitation Unit
    • Duration of mechanical ventilation or high flow oxygen devices
    • Duration of hospitalization
    • Rate of throat swab negativation at days 7, 14 and 28
    • Quantitative SARS-CoV-2 virus in throat swab at days 7, 14 and 28
    • Quantitative SARS-CoV-2 virus in blood at days 7, 14 and 28
    • Rate of secondary infection by other documented pathogens (bacteria, fungi)
    • Biological parameters (hematological parameters and markers of inflammation)
    • Safety of experimental treatments.
    And to perform Cost-Effectiveness Analyses (CEA) with Incremental Cost-Effectiveness Ratios (ICERs) expressed in cost per Life Year Gained.
    Les objectifs secondaires seront de décrire dans chaque bras de l'étude :
    • Temps à amélioration clinique
    • État clinique à J7, 14 et 28
    • Changement moyen de l’état clinique entre baseline et J7, 14 et 28
    • La survie globale
    • Durée du séjour en unité de soins intensifs et en unité de réanimation
    • Durée de la ventilation mécanique ou des dispositifs d’oxygène à haut débit
    • Durée d'hospitalisation
    • Taux de négativation de l'écouvillonnage pharyngé à J7, 14 et 28
    • Mesure quantitative du SRAS-CoV-2 dans un écouvillonnage pharyngé à J7, 14 et 28
    • Mesure quantitative du SRAS-CoV-2 dans le sang à J7, 14 et 28
    • Taux d'infection secondaire par d'autres agents pathogènes documentés (bactéries, champignons)
    • Paramètres biologiques (paramètres hématologiques et marqueurs de l'inflammation)
    • Tolérance des traitements expérimentaux
    Et de réaliser une analyses coût-efficacité avec ratio coût-efficacité incrémental exprimé en coût par année de vie gagnée.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Age 18 or older at the time of enrolment.
    I2. Histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization).
    I3. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) or symptoms of COVID-19 associated with radiological signs of pneumonia as described by Shi et al.;
    I4. Cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg.
    ...See the protocol
    I1. Age > 18 ans à la date de signature du consentement éclairé de participation
    I2. Diagnostic confirmé histologiquement de cancer solide ou hématologique, en situation avancée ou métastatique (quel que soit le type et la localisation)
    I3. Diagnostic de COVID-19 documenté (test de dépistage réalisé par un laboratoire certifié) ou symptômes de COVID-19 associés à des signes radiologiques de pneumonie tels que décrits par Shi et al. ;
    I4. Cohorte 2 : Patient présentant une pneumonie confirmée par une imagerie thoracique et une saturation en oxygène (Sao2) de 94% ou moins lorsqu’il respire l’air ambiant ou un rapport de la pression partielle d’oxygène (Pao2) à la fraction d’oxygène inspiré (Fio2) (Pao2:Fio2) égal ou inférieur à 300 mmHg.
    ...Voir le protocole
    E.4Principal exclusion criteria
    E1. For cohort 1 only : Patient currently receiving therapy with an anti- PD-1, anti- PD-L1, or anti-CTLA4.
    E2. For cohort 2 only: Patient currently receiving therapy with an anti- IL-6 or anti-IL-6R.
    E3. Contraindication to treatment with nivolumab (cohort 1 only) or to tocilizumab (cohort 2 only) as per respective SPC, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody.
    E4. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (e.g., quinine, chloroquine, mefloquine).
    ...See the protocol
    E1. Pour la cohorte 1 uniquement : patient recevant actuellement un traitement avec un anti-PD-1, anti-PD-L1 ou anti-CTLA4.
    E2. Pour la cohorte 2 uniquement : Patient recevant actuellement un traitement avec un anti-IL-6 ou anti-IL-6R.
    E3. Contre-indication au traitement par nivolumab (cohorte 1 uniquement) ou par tocilizumab (cohorte 2 uniquement) selon les RCP respectifs, y compris l'hypersensibilité connue à l'un de ces médicaments à l'étude ou une réaction d'hypersensibilité sévère à tout anticorps monoclonal.
    E4. Patient connu pour présenter une intolérance ou une hypersensibilité à la chloroquine ou à tout dérivé de la quinoline (par exemple, quinine, chloroquine, méfloquine).
    ...Voir le protocole
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the 28-day survival rate, defined by the proportion of patients still alive 28 days after randomization.
    Le critère de jugement principal sera le taux de survie à 28 jours, défini par la proportion de patients en vie 28 jours après la randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28-day
    28 jours
    E.5.2Secondary end point(s)
    • Time to clinical improvement
    • Clinical status at D7, D14 and D28 • Mean change in clinical status from baseline to days 7, 14 and 28
    • Overall survival
    ...See the protocol
    • Temps nécessaire à l'amélioration clinique
    • État clinique à J7, J14 et J28
    • Changement moyen de l'état clinique de la ligne de base aux jours 7, 14 et 28
    • La survie globale
    ... Voir le protocole
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessment at a beginning and throughout the study
    Evaluation au début et ce tout au long de l'étude
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Information not present in EudraCT
    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) Information not present in EudraCT
    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 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 No
    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 concerned7
    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
    Dernière visite du dernier patient
    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 months6
    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: 147
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 126
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state273
    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)
    Investigator’s discretion
    A la discrétion du médecin
    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 Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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