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    Summary
    EudraCT Number:2020-000936-23
    Sponsor's Protocol Code Number:C20-15
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-12-18
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-000936-23
    A.3Full title of the trial
    Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults
    Multicentrická, adaptivní, randomizovaná studie bezpečnosti a účinnosti léčby u hospitalizovaných dospělých pacientů s COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of treatments of COVID-19 in hospitalized adults (Discovery)
    Bezpečnost a účinnost léčby COVID-19 u hospitalizovaných dospělých pacientů (Discovery)
    A.3.2Name or abbreviated title of the trial where available
    Discovery
    Discovery
    A.4.1Sponsor's protocol code numberC20-15
    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 SponsorINSERM
    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 supportEuropean Union
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSERM
    B.5.2Functional name of contact pointJuliette SAILLARD
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis Cedex 13
    B.5.3.3Post code756 54
    B.5.3.4CountryFrance
    B.5.4Telephone number33144236720
    B.5.6E-mailjuliette.saillard@inserm.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 Veklury
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC, Carrigtohill, Ireland
    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.3.1Product nameRemdesivir
    D.3.4Pharmaceutical form Lyophilisate for 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 INNREMDESIVIR
    D.3.9.1CAS number 1809249-37-3
    D.3.9.4EV Substance CodeSUB195655
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 infection
    Infekce COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID 19
    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
    The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19.
    • The primary endpoint is subject clinical status (on a 7-point ordinal scale) at Day 15
    Celkovým cílem studie je vyhodnotit klinickou účinnost a bezpečnost různých hodnocených terapeutik ve srovnání s kontrolní skupinou u hospitalizovaných pacientů s COVID-19.
    • Primárním parametrem je klinický stav subjektu (na 7 bodové ordinální stupnici) v Den 15.
    E.2.2Secondary objectives of the trial
    - Evaluate clinical efficacy of investigational therapeutics as compared to control arm :
    Ordinal scale:
    • Time to an improvement of one category from admission on an ordinal scale.
    • Time to an improvement of two categories or discharge from admission on an ordinal scale.
    • Time to discharge (categories 1 or 2 of scale) from admission.
    • Subject clinical status on an ordinal scale on D3, 5, 8, 11, and 29.
    • Mean change in the ranking on an ordinal scale from baseline to D3, 5, 8, 11, 15 and 29.
    National Early Warning Score
    - Oxygenation free days in the first 28 days, duration of new oxygen use, non-invasive ventilation or high flow oxygen devices.
    Mechanical Ventilation:
    • Ventilator free days in the first 28 days.
    • Duration of new mechanical ventilation use.
    - Duration of hospitalization.
    - Mortality : In-hospital mortality, 28-day and 90-day mortality.
    Safety : Evaluate safety of investigational therapeutics through 28 days as compared to control arm

    -Vyhodnocení klinické účinnosti hodnocených terapeutik ve srovnání s kontrolní skupinou:
    Ordinální stupnice:
    • Čas na zlepšení o jednu kategorii od přijetí v ordinální stupnici
    • Čas na zlepšení o dvě kategorie nebo propuštění od přijetí v ordinální stupnici
    • Čas do propuštění (kategorie stupnice 1 nebo 2) od přijetí
    • Klinický stav subjektu na ordinální stupnici v D3, 5, 8, 11 a 29
    • Průměrná změna v pořadí na ordinální stupnici od baseline do D3, 5, 8, 11, 15 a 29
    National Early Warning Score
    - Dny bez kyslíku v prvních 28 dnech, doba používání nového kyslíku, neinvazivní ventilace nebo kyslíková zařízení s vysokým průtokem.
    Mechanická ventilace:
    • Dny bez ventilace v prvních 28 dnech.
    • Doba trvání nového použití mechanické ventilace.
    -Doba hospitalizace.
    -Mortalita: mortalita v nemocnici, 28denní a 90denní úmrtnost.
    Bezpečnost: vyhodnocení bezpečnosti hodnocených terapeutik po dobu 28 dnů ve srovnání s kontrolní skupinou.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult ≥18 years of age at time of enrolment.
    2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 9 days hours prior to randomization.
    3. Hospitalized patients with illness of any duration, and at least one of the following:
    • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air,
    OR
    • Acute respiratory failure requiring supplemental oxygen, high flow oxygen devices, non-invasive ventilation, and/or mechanical ventilation.
    4. Women of childbearing potential must agree to use contraception for the duration of the study. Acceptable birth control methods are listed in section

    1. Dospělý ≥18let v době zařazení do klinického hodnocení
    2. Laboratorně potvrzená infekce SARS-CoV-2 za pomocí PCR nebo jiným komerčním či veřejným testem vzorku <9 dnů před randomizací
    3. Hospitalizovaní pacienti s onemocněním jakéhokoliv trvání a s nejméně jednou z následujících podmínek:
    • klinické zhodnocení, dýchavičnost a SpO2 ≤ 94%
    nebo
    • akutní respirační syndrom vyžadující dodatečné podání kyslíku nebo vyžadující podání kyslíku při vysokém průtoku, neinvazivní ventilací, a/nebo mechanickou ventilaci.
    4. Ženy ve fertilním věku musí souhlasit s používáním antikoncepce po celou dobu studie.
    E.4Principal exclusion criteria
    1. Refusal to participate expressed by patient or legally authorized representative if they are present
    2. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal.
    3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min)
    4. Pregnancy or breast-feeding.
    5. Anticipated transfer to another hospital, which is not a study site within 72 hours.
    6. Patients previously treated with one of the antivirals evaluated in the trial (i.e. remdesivir, interferon ß-1a, lopinavir/ritonavir, hydroxychloroquine) in the past 29 days
    7. Contraindication to any study medication including allergy
    8. Use of concomitant Ribavirin in the past 29 days and/or concomitantly to randomization
    1. Odmítnutí účasti vyjádřené pacientem nebo zákonným zástupcem, pokud je přítomen
    2. Jaterní enzymy ALT/AST hladiny > 5 x vyšší než je horní limit pro normální hodnoty
    3. Stádium 4 chronického onemocnění ledvin nebo vyžadující dialýzu (např. eGFR < 30 mL/min)
    4. Těhotenství nebo kojení.
    5. Očekávaný transfer do jiné nemocnice, která není studijním centrem během 72 hodin.
    6. Pacienti, kteří již byli léčeni jedním z antivirotik hodnocených v této studii (např. remdesivir, interferon ß-1a, lopinavir/ritonavir, hydroxychloroquine) v posledních 29 dnech.
    7. Kontraindikace ke studijní medikaci včetně alergie.
    8. Použití kontraindikované medikace Ribavirin za posledních 29 dní a/nebo souběžně s randomizací.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical status of subject on Day 15 (on a 7-point ordinal scale):
    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.
    Klinický stav subjektu v den 15 (na 7bodové ordinální stupnici):
    1. Není hospitalizován, žádná omezení aktivit
    2. Není hospitalizován, omezení aktivit;
    3. Hospitalizovaní, nevyžadující doplňkový kyslík;
    4. Hospitalizovaní, vyžadující doplňkový kyslík;
    5. hospitalizován na neinvazivní ventilaci nebo kyslíkových zařízeních s vysokým průtokem;
    6. hospitalizován na invazivní mechanické ventilaci nebo ECMO;
    7. Smrt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 15
    Den 15
    E.5.2Secondary end point(s)
    • Status on an ordinal scale assessed daily while hospitalized and on Days 15 and 29.
    • NEWS assessed daily while hospitalized and on Days 15 and 29.
    • Duration of supplemental oxygen (if applicable).
    • Duration of mechanical ventilation (if applicable).
    • Duration of hospitalization.
    • In-hospital mortality, 28-day mortality and 90-day mortality with date and cause of death (if applicable).
    • Grade 3 and 4 adverse events
    • SAEs.
    • Routine blood biological parameters measured at baseline/day 1: inflammatory status: serum total immunoglobulins.
    • Routine blood biological parameters measured at days 1, 3, 5, 8, 11 (while hospitalized or in the outpatient setting); and days 15 and 29 (in the hospital, or, if discharged in the outpatient setting):
    -blood electrolytes: natremia, kaliemia, glycemia;
    -renal function: creatininemia, urea;
    -liver enzymes and hepatic function: total bilirubin, LDH, ALT, AST, gamma glutamyl transferase, alcalin phosphatase;
    -cell counts: white cells including neutrophils and total lymphocyte counts, red cells through haemoglobin, platelets,
    -coagulation: fibrinogen, D-Dimer, prothrombin time and international normalized ratio [INR],
    -inflammatory status: C-reactive protein, ferritinemia.
    • Stav na ordinální stupnici posuzován denně během hospitalizace a ve dnech 15 a 29.
    • Nové zprávy hodnoceny denně během hospitalizace a 15. a 29. den.
    • Doba trvání doplňkového kyslíku (je-li k dispozici).
    • Doba trvání mechanické ventilace (je-li k dispozici).
    • Délka hospitalizace.
    • Úmrtnost v nemocnici, 28denní a 90denní úmrtnost s datem a příčinou úmrtí (pokud existují).
    • Nežádoucí účinky stupně 3 a 4
    • SAE
    • Rutinní biologické parametry krve měřené na baseline / den 1: zánětlivý stav: celkové sérové ​​imunoglobuliny.
    • Rutinní biologické parametry krve měřené 1., 3., 5., 8., 11. den (během hospitalizace nebo ambulantní péče); a 15. a 29. den (v nemocnici nebo v případě ambulantního propuštění):
    - krevní elektrolyty: natremie, kalemie, glycemie;
    - funkce ledvin: kreatinin, močovina;
    - jaterní enzymy a jaterní funkce: celkový bilirubin, LDH, ALT, AST, gama glutamyltransferáza, alkalická fosfatáza;
    - počet buněk: bílé krvinky včetně neutrofilů a celkový počet lymfocytů, červené krvinky prostřednictvím hemoglobinu, krevní destičky,
    - koagulace: fibrinogen, D-dimer, protrombinový čas a mezinárodní normalizovaný poměr [INR],
    -zánětlivý stav: C-reaktivní protein, ferritin.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 15, Day 29
    Mortality : Day 28 and Day 90
    Den 15, Den 29
    Mortalita: Den 28 a Den 90
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Turkey
    Austria
    Belgium
    Czechia
    France
    Hungary
    Ireland
    Luxembourg
    Poland
    Portugal
    Slovakia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    Patients admitted in ICU
    Pacienti přijatí na JIP
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3100
    F.4.2.2In the whole clinical trial 3100
    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)
    No post trial treatment as patient should be cured
    Žádná léčba po ukončení léčby ve studii, pacient by měl být vyléčen.
    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 Decision2021-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
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