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    Summary
    EudraCT Number:2020-001734-36
    Sponsor's Protocol Code Number:DR200111
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001734-36
    A.3Full title of the trial
    Efficacy and safety of ANAkinra during Adult « COVID-19 » with Aggravating respiratory symptoms: a multicenter open-label controlled randomized trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of ANAkinra during Adult « COVID-19 » with Aggravating respiratory symptoms: a multicenter open-label controlled randomized trial
    A.3.2Name or abbreviated title of the trial where available
    ANACONDA-COVID-19
    A.4.1Sponsor's protocol code numberDR200111
    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 SponsorCHRU de TOURS
    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 supportCHRU de TOURS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de TOURS
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street Address2, Bd Tonnelé
    B.5.3.2Town/ cityTours
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number+33627165742
    B.5.6E-maile.mousset@chu-tours.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 nameKineret
    D.3.4Pharmaceutical form 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 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 Yes
    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 infection
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the ANACONDA-COVID-19 trial is to assess the efficacy of Anakinra + optimized Standard of Care (oSOC) as compared to oSOC alone on the condition of patients with COVID-19 infection and worsening respiratory symptoms. Success defined as patient alive and free of invasive mechanical ventilation (IMV) and free of Extracorporeal Membrane Oxygenation (ECMO) at Day 14.
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of Anakinra + oSOC as compared to oSOC alone on:
    - Treatment success (same definition than primary outcome) up to Day 28
    - Patient’s condition as defined by the OMS 7 point scale up to Day 28
    - Patient’s mortality up to Day 28
    - Patient’s admission in ICU
    - Pulmonary function (need for ventilator support, SP02, PaO2/FiO2) up to Day 28
    - Inflammation parameters up to Day 28
    2. To evaluate the safety profile of Anakinra
    3. To identify Biomarkers of efficacy of Anakinra.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female≥ 18 years of age
    - Written informed consent of the patient or a proxy
    - Ability for participant to comply with the requirements of the study
    - Hospitalized patient with COVID-19 defined as
    • Positive SARS-CoV2 RT-PCR
    • Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out.

    - Patient with respiratory symptoms and requirement of oxygen therapy as defined:
    • Oxygen therapy >= 4L/min to maintain Sp02>92% and respiratory rate >=24/min.
    • Or patients under oxygen >= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy >= 2L/min to maintain Sp02>92%.

    - Inflammatory component C-Reactive Protein ≥ 50mg/L.
    - Patients within the first 20 days from the onset of the first COVID-19 symptoms
    - Probabilistic antibiotics therapy according to local practice
    E.4Principal exclusion criteria
    - Respiratory failure related to other cause than COVID-19
    - Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02>92%
    - Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis
    - Contra indication to anti-IL1 receptor
    • Known hypersensitivity to Anakinra
    • Absolute neutrophil count (ANC)< 1500/mm3
    • Liver cirrhosis score de Child-Pugh class C
    • Live or attenuated vaccine in the past 8 weeks
    • Pregnant or breast-feeding women
    - Patients with either legally protected status or who have been deprived of their freedom
    - Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted)
    - Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFα within 21 days preceding inclusion
    - Absence of Health Insurance
    - Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is treatment success at Day 14, defined as a patient alive and not requiring any of the following: Invasive mechanical ventilation (IMV) or Extracorporeal membrane oxygenation (ECMO).
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days
    E.5.2Secondary end point(s)
    1. Efficacy outcomes:
    - Treatment success (same definition as the Primary outcome) at Day 3, Day 10 and Day 28
    - OMS progression scale (on a 7-point ordinal scale): at Day 3, Day 10, Day 14 and Day 28
    1. Not hospitalized, no limitations on activities
    2. Not hospitalized, limitation on activities;
    3. Hospitalized, not requiring supplemental oxygen;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6. Hospitalized, on invasive mechanical ventilation or ECMO;
    7. Death.
    - Overall survival at Day 3, Day 10, Day 14 and Day 28
    - Time to ICU admission
    - Time to ventilatory support (ECMO, invasive mechanical ventilation, non-invasive ventilation, high flow oxygen therapy)
    - Change in NEWs score from baseline to Day 3, Day 10, Day 14 and Day 28
    - Change in HScore from baseline to Day 3, Day 10, Day 14 and Day 28
    - Change in inflammatory parameters (CRP, ferritin, D-dimer, fibrinogen, lymphocytes count, platelet count) from baseline to Day 3, Day 10, Day 14 and Day 28
    - Hospital length of stay: Time from inclusion to hospital discharge
    For those admitted in ICU:
    - Need for Vasopressors (yes or no)
    - If IMV, Evolution of SpO2/FIO2
    - If IMV, Evolution of PaO2/FiO2 ratio
    - ICU length of stay: Time from admission in ICU to ICU discharge
    Secondary outcomes of the trial will be updated according to the COS for COVID-19.
    2. The safety outcomes:
    Occurrence of serious adverse events during the study, including bacterial infection, septic shock, hepatitis (SGOT/SGPT, alkaline phosphatase, gammaGT) and neutropenia (Blood count).
    3. Predictors of efficacy of Anakinra:
    The association between several of clinical parameters at inclusion (including level of oxygen requirement, respiratory rate, temperature…), biological parameters (including, CRP, ferritin, LDH, lymphocyte count, eosinophil count, Ddimers, platelet count, polymorphonuclear count...), and cytokines profile analysis with the primary end point will be explored.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 concerned47
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days28
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 192
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Emergency situation or confusion state
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    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 Decision2020-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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