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    Summary
    EudraCT Number:2020-001162-12
    Sponsor's Protocol Code Number:EFC16844
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-20
    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 ConcernedGermany - PEI
    A.2EudraCT number2020-001162-12
    A.3Full title of the trial
    An adaptive phase 3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Sarilumab COVID-19
    A.4.1Sponsor's protocol code numberEFC16844
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1249-6021
    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 SponsorSanofi-aventis Recherche et Développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-aventis Recherche et Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.com
    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 Kevzara®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection in pre-filled syringe
    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 INNSARILUMAB
    D.3.9.2Current sponsor codeSAR153191
    D.3.9.4EV Substance CodeSUB177914
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Corona virus infection
    E.1.1.1Medical condition in easily understood language
    Corona virus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19
    E.2.2Secondary objectives of the trial
    Evaluate the 28-day survival rate,Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity, changes in the National Early Warning Score 2, duration of predefined symptoms and signs, duration of supplemental oxygen dependency, incidence of new mechanical ventilation use, proportion of patients requiring rescue medication, need for admission into ICU, duration of hospitalization.
    Secondary safety objectives are to evaluate the safety of sarilumab compared to the control arm as assessed by incidence of: SAEs, Major or opportunistic bacterial or fungal infections in patients with grade 4
    neutropenia , Grade ≥2 infusion related reactions, Grade ≥2 hypersensitivity reactions, Increase in ALT ≥3X ULN (for patients with normal baseline) or >3X ULN and at least 2-fold increase from baseline value (for patients with abnormal baseline), Major or opportunistic bacterial or fungal infections.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must be ≥18 years of age
    Participants must be hospitalized for less than or equal to 7 days with
    evidence of pneumonia and have one of the following disease categories:
    severe disease or critical disease
    Laboratory-confirmed SARS-CoV-2 infection
    E.4Principal exclusion criteria
    Unlikely to survive after 48 hours from screening or unlikely to remain at
    the investigational site beyond 48 hours. Patients with multi organ dysfunction or requiring extracorporeal life support or renal replacement
    therapy are excluded.
    Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than
    5 X ULN, platelets less than 50,000/mmˆ3
    Prior immunosuppressive therapies
    Use of chronic oral corticosteroids for non-COVID-19 related condition
    Known or suspected history of tuberculosis
    Suspected or known active systemic bacterial or fungal infections
    E.5 End points
    E.5.1Primary end point(s)
    Time to improvement of 2 points in clinical status assessment from baseline using the 7-point ordinal scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Day 29
    E.5.2Secondary end point(s)
    1 - Percent of patients alive at Day 29
    2 - Proportion of patients with one point improvement from baseline in
    clinical status assessment at days 4, 7, 15, 21, 29 using the 7-point
    ordinal scale
    3 - Mean change in the 7-point ordinal scale from baseline to days 4, 7,
    15, 21, and 29 (or until discharge)
    4 - Time to resolution of fever
    5 - Time to resolution of fever and improvement in oxygenation
    6 - Days with fever
    7 - Time to change in NEWS2 from baseline
    8 - Time to NEWS2 of <2 and maintained for 24 hours
    9 - Mean change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS2
    10 - Time-to-improvement in oxygenation
    11 - Alive off supplemental oxygen at day 29
    12 - Days of hypoxemia
    13 - Days of supplemental oxygen use
    14 - Days of resting respiratory rate >24 breaths/min
    15 - Time to saturation ≥94% on room air
    16 - Ventilator free days in the first 28 days (to day 29)
    17 - The number of patients with Initiation of mechanical ventilation,
    non-invasive ventilation, or use of high flow nasal cannula
    18 - Proportion of patients requiring rescue medication during the 28-
    day period
    19 - The number of patients transferred to the ICU or the need to
    transfer to the ICU (if the ICU is not available)
    20 - Days of hospitalization among survivors
    21 - Incidence of serious adverse events
    22 - The incidence of major or opportunistic bacterial or fungal infections
    23 - The incidence of major or opportunistic bacterial or fungal infections
    in patients with grade 4 neutropenia
    24 - The incidence of hypersensitivity reactions, infusion reactions,
    gastrointestinal perforation
    25 - The number of patients with clinically significant laboratory
    abnormalities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: Day 29
    2-3, 9 : Baseline to Days 4, 7, 15, 21, 29
    4-8, 10-16 : Baseline to Day 29
    17, 19-24 : Baseline to Day 60
    18 : Baseline to Day 28
    25 : Days 1, 4,7,15, 21 and 29 (if still hospitalized)
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Russian Federation
    Spain
    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 years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 176
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 264
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-03-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally acceptable representative may provide informed consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 440
    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 Decision2020-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-09-02
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