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    Summary
    EudraCT Number:2020-001963-10
    Sponsor's Protocol Code Number:2020-CHITS-003
    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:2020-04-20
    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 number2020-001963-10
    A.3Full title of the trial
    Interleukin-1 (IL-1) and Interferon gamma (IFNg) inhibition during COVID 19 inflammation: Randomized, controlled study assessing efficacy and safety of Anakinra and Ruxolitinib
    Etude de l’inhibition de l’IL-1 et de l’IFNγ dans la maladie COVID-19 : effet thérapeutique de l’anakinra et du ruxolitinib dans les formes graves
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interleukin-1 (IL-1) and Interferon gamma (IFNg) inhibition during COVID 19 inflammation: Randomized, controlled study assessing efficacy and safety of Anakinra and Ruxolitinib
    Etude de l’inhibition de l’IL-1 et de l’IFNγ dans la maladie COVID-19 : effet thérapeutique de l’anakinra et du ruxolitinib dans les formes graves
    A.3.2Name or abbreviated title of the trial where available
    JAKINCOV
    A.4.1Sponsor's protocol code number2020-CHITS-003
    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 Hospitalier Intercommunal de Toulon La Seyne-sur-mer
    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 supportcentre hospitalier intercommunal toulon la seyne sur mer
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Intercommunal de Toulon La Seyne sur mer
    B.5.2Functional name of contact pointAsmaa Jobic
    B.5.3 Address:
    B.5.3.1Street Address54 rue Henri Sainte Claire Deville
    B.5.3.2Town/ cityToulon
    B.5.3.3Post code83056
    B.5.3.4CountryFrance
    B.5.4Telephone number00330494145519
    B.5.5Fax number0030494145526
    B.5.6E-mailasmaa.jobic@ch-toulon.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 kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum AB
    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 nameAnakinra
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 300
    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) 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 Jakavi
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm
    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 nameRuxolitinib
    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.3.8INN - Proposed INNRUXOLITINIB
    D.3.9.1CAS number 941678-49-5
    D.3.9.3Other descriptive nameRUXOLITINIB
    D.3.9.4EV Substance CodeSUB32273
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 disease
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    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
    To compare clinical and biological efficacy of a therapeutic strategy using ANAKINRA with or without RUXOLITINIB for serious cases of SARS-CoV-2 infection, oxygen dependent, needing or not an invasive ventilation on systemic inflammation
    Comparer l’efficacité d’une stratégie thérapeutique utilisant l’ANAKINRA avec ou sans RUXOLITINIB dans les formes graves d’infection à SARS-CoV-2, oxygéno-dépendantes, nécessitant ou non une ventilation invasive sur l’inflammation systémique.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of this strategy on :
    • The number of days of oxygen dependency
    • The number of admission in the intensive care for patient of regular unit (Expected result : 20% decrease, admission fall in number from 50% to 30%)
    • Patients’ mortality at D28 (Expected result : 20% decrease)
    • Length of stay in the intensive care unit (Expected result : 3 days decrease)
    • Length of stay in the hospital (Expected result : 3 days decrease)
    • The evolution of organ failure score SOFA (Expected result : 3 points decrease)
    • The number of days without fever at D7 (Expected result : 2 days decrease)
    • The absence of increase on number of bacterial or fungal sepsis of more than 10%
    Comparer l’efficacité de cette stratégie sur :

    - Le nombre de jours d’oxygéno-dépendance

    - Le nombre d’admission en réanimation pour les patients de service conventionnel (Résultats attendus : Réduction possible de 20 %, passage de 50 à 30 % d’admission)

    - La mortalité pour tous les patients à J28 (Résultats attendus : réduction de 20 %)

    - La durée de séjour en réanimation (Résultats attendus : réduction de 3 jours)

    - La durée de séjour à l’hôpital (Résultats attendus : réduction de 3 jours)

    - L’évolution du score de défaillance d’organe, score SOFA (Résultats attendus : réduction de 3 points)

    - Le nombre de jours sans fièvre à J7 (Résultats attendus : réduction de 2 jours)

    - L’absence d’augmentation du nombre de sepsis d’origine bactérienne ou fungique de plus de 10 %
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women and men, age ≥ 18 years.
    Confirmed respiratory tract SARS-coV-2 infection by at least one nasopharygeal sample or bronchoalveolar lavage PCR.
    Patient hospitalized with clinical, biological and radiological features corresponding to following stages :
    Stage 2B: corresponds to stage 2A, but with hypoxemia (Sa02 < 90 mmHg on room air,respiratory rate > 30/min) with biological inflammatory syndrome (CRP>150mg/l) .
    - Stage 3: ARDS defined as mechanically ventilated patient with PaO2/FiO2 < 300 mmHg for more than 24h., acute respiratory insufficiency and a systemic hyper inflammatory syndrome which is sometimes complicated by hemophagocytic lymphohistiocytosis and multi-organ failure syndrome.
    - Severe Stage 3 : ARDS as described above associated with any organ failure or syndrome such as :
    • Shock with noradrenaline > 3mg/h
    • Severe oligo-anuric renal insufficiency or necessitate renal dialysis
    • Hepatocellular insufficiency or coagulopathy with factor V < 50%
    • Myocarditis that caused severe heart failure and/or cardiogenic shock
    • Hemophagocytic syndrome
    High ferritin > 5000 ng/mL
    Social Security affiliation or entitled to universal healthcare cover.
    Subject or legal representative having expressed written consent after information.
    • Femmes et hommes âgés de 18 ans ou plus

    • Infection confirmée des voies respiratoires à SARS-CoV-2 par au moins une PCR sur prélèvement nasopharyngé ou un lavage broncho-alvéolaire

    • Patient hospitalisé, présentant un tableau clinique, biologique et radiologique correspondant aux stades suivants :
    - Stade 2b : pneumonie hypoxémiante (fréquence respiratoire > 30/min, Sat O2 < 90 mmHg en air ambiant) associée à un syndrome inflammatoire biologique marqué (CRP > 150mg/l)

    - Stade 3 : SDRA défini par un patient sous ventilation mécanique présentant un rapport PaO2 / FiO2 < 300 pendant plus de 24h

    - Stade 3 évolué : SDRA selon la définition antérieure associé à une autre défaillance d’organe ou syndrome parmi :
    • Un état de choc avec une posologie de noradrénaline > 3 mg/h
    • Une insuffisance rénale aiguë oligo-anurique ou justifiant l’épuration extra-rénale
    • Une insuffisance hépatocellulaire ou une coagulopathie avec un facteur V < 50%
    • Une myocardite responsable d’une insuffisance cardiaque aigue et ou d’un choc cardiogénique
    • Un syndrome hémophagocytaire
    • Une hyperferritinémie > 5000 ng/mL

    • Sujet affilié ou bénéficiaire d’un régime de sécurité sociale
    Sujet ou son représentant légal ayant exprimé son consentement par écrit après information
    E.4Principal exclusion criteria
    Pregnant or lactating women
    Patients transplanted with solid organs or hematopoietic stem cells
    HIV, HBV or HCV infection
    Non treated bacterial or mycotic infection
    Refusal to participate in the study
    Patient under administrative or judicial supervision
    Patient on exclusion period from another research
    Patient receiving psychiatric treatment according to article L3112-1 and L3113-1 which do not apply to article L1121-8
    Patient not able to read or understand french language which might prevent him from consenting to participate
    Any condition which could compromise safety of the patient or interfere in the conduct of the research according to the investigator.
    • Femmes enceintes (grossesse connue) ou allaitantes ou planifiant d’être enceinte durant toute la durée de sa participation à la recherche.
    • Patients greffés d’organes solides ou de cellules souches hématopoïétiques
    • Infection par le VIH, le VHB ou le VHC
    • Infection bactérienne ou mycotique non traitée
    • Hypersensibilité à l’anakinra et/ou au ruxolitinib
    • Personnes privées de liberté par une décision judiciaire ou administrative ou personnes majeures faisant l’objet d’une mesure de protection légale
    • Personne en période d’exclusion d’un autre protocole de recherche au moment de la signature du consentement/non opposition
    • Personnes faisant l’objet d’un suivi psychiatrique en vertu des articles L3112-1 et L3113-1 qui ne relèvent pas des dispositions de l’article L1121-8
    • Personne ne maîtrisant pas assez la lecture et la compréhension de la langue française pour être capable de consentir à participer à la recherche
    Toute condition qui, de l’avis de l’investigateur, pourrait accroitre et compromettre la sécurité de la personne dans le cas où elle participerait à cette recherche ou interférer avec les résultats de la recherche
    E.5 End points
    E.5.1Primary end point(s)
    Biological criteria: validation if at least 3 parameters are met including CRP and/or Ferritin
    1) CRP : decrease > 50%
    2) Ferritinemia : decrease > 1/3
    3) Serum creatinine : decrease > 1/3
    4) AST/ALT : decrease > 50%
    5) Eosinophils > 50 /mm3
    6) Lymphocytes > 1000 /mm3
    Critère biologique : validation du critère si au moins 3 paramètres validés (dont la CRP et/ou la ferritine), parmi :
    1) CRP : diminution > 50 %
    2) Ferritinémie : diminution > 1/3
    3) Créatininémie : diminution > 1/3
    4) TGO/TGP : diminution > 50 %
    5) Eosinophiles > 50 / mm3 en VA
    6) Lymphocytes > 1000 /mm3 en VA
    E.5.1.1Timepoint(s) of evaluation of this end point
    D7, D10, D14, D28
    J7, J10, J14, J28
    E.5.2Secondary end point(s)
    - number of days of oxygen dependency
    - number of admission in the intensive care for patient of regular unit (patient enrolled at stage 2b)
    - mortality at D28
    - number of days in the intensive care unit
    - total number of days in the hospital
    - organ failure score SOFA progress
    - number of days without fever at D7
    - number of bacterial or fungal sepsis
    Nombre de jours d’oxygéno-dépendance
    Nombre d’admission en réanimation (patients inclus au stade 2b)
    Nombre de jours en réanimation (patients pris en charge en réanimation)
    Mortalité à J28
    Nombre de jours totaux d’hospitalisation
    Amélioration des défaillances d’organe (score SOFA)
    Nombre de jours sans fièvre à J7 (sans antipyrétiques pendant 48h)
    Nombre de sepsis bactériens et fungiques
    E.5.2.1Timepoint(s) of evaluation of this end point
    D7, D10, D14, D28
    J7, J10, J14, J28
    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) 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 de soins
    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 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
    last patient last visit
    dernière visite du dernier patient inclus
    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 months3
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    inconscious patient
    patients inconscients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    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 Decision2020-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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