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    Summary
    EudraCT Number:2020-000841-15
    Sponsor's Protocol Code Number:GS-US-540-5773
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000841-15
    A.3Full title of the trial
    A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Severe COVID-19
    Studio di fase 3, randomizzato volto a valutare la sicurezza e l’attività antivirale di Remdesivir (GS-5734TM) in partecipanti affetti da COVID-19 grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will test a drug named remdesivir (GS-5734™) to evaluate the safety and effectiveness of the drug in treating patients with severe coronavirus disease 2019 (COVID-19).
    Studio per valutare la sicurezza e l’efficacia medicinale di nome remdesivir (GS-5734™) in pazienti con infezione grave da coronavirus (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numberGS-US-540-5773
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityGreat Abington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.5Fax number00441223897284
    B.5.6E-mailclinical.trials@gilead.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 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 nameRemdesivir
    D.3.2Product code GS-5734
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    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.3.9.2Current sponsor codeGS-5734
    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
    Coronavirus disease 2019 (COVID-19)
    Infezione da coronavirus 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019 (COVID-19)
    Infezione da coronavirus 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus 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 efficacy of two remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14
    Valutare l’efficacia di 2 regimi di RDV in termini di normalizzazione della temperatura e saturazione di ossigeno fino al Giorno 14
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of RDV
    Valutare la sicurezza e la tollerabilità di RDV
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent prior to performing study procedures
    2) Aged ≥ 18 years
    3) SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization
    4) Currently hospitalized with fever defined as ≥ 36.6 °C armpit, ≥ 37.2°C oral, ≥ 37.8 °C rectal
    5) SpO2 > 94% on room air at screening
    6) Radiographc evidence of pulmonary infiltrates
    7) Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Protocol Appendix 3.
    1) Disponibilità e capacità di fornire il consenso informato per iscritto prima dell’esecuzione delle procedure dello studio
    2) Età = 18 anni
    3) Infezione da SARS-CoV-2 confermata mediante test della PCR = 4 giorni precedenti la randomizzazione
    4) Attuale ricovero ospedaliero con febbre definita come temperatura ascellare = 36,6 °C, orale = 37,2 °C, rettale = 37,8 °C
    5) Saturazione dell'ossigeno (SpO2) in aria ambiente = 94% allo Screening
    6) Evidenza radiografica di infiltrati polmonari
    7) Uomini e donne in età fertile che abbiano rapporti eterosessuali devono acconsentire all’utilizzo di uno o più metodi contraccettivi specificati nel protocollo.
    E.4Principal exclusion criteria
    1) Participation in any other clinical trial of an experimental treatment for COVID-19
    2) Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing
    3) Evidence of multiorgan failure
    4) Requiring mechanical ventilation at screening
    5) ALT or AST > 5 x upper limit of normal (ULN)
    6) Creatinine clearance < 50 mL/min
    7) Positive pregnancy test (Protocol; Appendix 3)
    8) Breastfeeding woman
    9) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
    1) Partecipazione a qualsiasi altra sperimentazione clinica di un trattamento sperimentale per COVID-19
    2) Trattamento concomitante con altri agenti con effettiva o possibile attività antivirale ad azione diretta contro SARS-CoV-2 proibito < 24 ore prima della dose del farmaco sperimentale
    3) Evidenza di insufficienza multiorgano
    4) Necessità di ventilazione meccanica allo Screening
    5) Alanina aminotransferasi (ALT) o a aspartato aminotransferasi (AST) > 5¿ il limite superiore della norma (Upper Limit of Normal, [ULN])
    6) Clearance della creatinina < 50 ml/min
    7) Test di gravidanza positivo
    8) Donne durante l’allattamento al seno
    9) Ipersensibilità nota verso il farmaco sperimentale, i metaboliti o l’eccipiente della formulazione
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants in each group with normalization of fever and oxygen saturation [criteria for normalization: temperature < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal; and SpO2 > 94%, sustained for at least 24 hours] through Day 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    From initiation of study medication until Day 14
    E.5.2Secondary end point(s)
    The proportion of participants with treatment emergent adverse events leading to study drug discontinuation
    E.5.2.1Timepoint(s) of evaluation of this end point
    From initiation of study medication until Day 14
    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) No
    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 EEA12
    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
    China
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    United States
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Men of childbearing potential who engage in heterosexual intercourse using contraception
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 400
    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)
    The long-term care of the participant will remain the responsibility of their primary treating physician. Remdesivir is being supplied with curative intent. There is no provision for post-study availability.
    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 Decision2020-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
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