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    Summary
    EudraCT Number:2020-001803-17
    Sponsor's Protocol Code Number:GS-US-540-5823
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001803-17
    A.3Full title of the trial
    A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants from Birth to < 18 Years of Age with COVID-19
    Studio in aperto di Fase 2/3 a braccio singolo, volto a valutare la sicurezza, la tollerabilità, la farmacocinetica, e l’efficacia di remdesivir (GS-5734™) in partecipanti dalla nascita a < 18 anni di età affetti da COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2/3 study of Remdesivir in patients from birth to <18 years old with COVID-19
    Studio di Fase 2/3 di remdesivir in pazienti dalla nascita a < 18 anni di età affetti da COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Phase 2/3 study of Remdesivir in patients from birth to <18 years old with COVID-19
    Studio di Fase 2/3 di remdesivir in pazienti dalla nascita a < 18 anni di età affetti da COVID-19
    A.4.1Sponsor's protocol code numberGS-US-540-5823
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/201/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGILEAD SCIENCES INCORPORATED
    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 number00441223897284
    B.5.5Fax number000000
    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 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.3.9.2Current 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 safety and tolerability of remdesivir (RDV ) in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years.
    • To evaluate the pharmacokinetics (PK) of RDV in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years.
    • Valutare la sicurezza e la tollerabilità di remdesivir (RDV) in partecipanti affetti da COVID-19 confermata in laboratorio di età compresa tra 0 giorni e < 18 anni.
    • Valutare la farmacocinetica (PK) di RDV in partecipanti affetti da COVID-19 confermata in laboratorio di età compresa tra 0 giorni e < 18 anni.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of RDV in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years.
    • To determine the antiviral activity of RDV in participants with laboratoryconfirmed COVID-19 aged 0 days to < 18 years.
    • Change from baseline in oxygenation use.
    • Change from baseline in the use of mechanical ventilation or extra corporeal membrane oxygenation (ECMO).
    • To evaluate clinical improvement using the PEWS scale in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years.
    • Determine sulfobutylether ß-cyclodextrin sodium (SBECD) exposures (where possible).
    • To provide data on use of medications other than RDV for treatment of COVID-19.
    • Valutare l’efficacia di RDV in partecipanti affetti da COVID-19 confermata in laboratorio di età compresa tra 0 giorni e < 18 anni
    • Determinare l'attività antivirale di RDV in partecipanti affetti da COVID-19 confermata in laboratorio di età compresa tra 0 giorni e < 18 anni
    • Variazioni rispetto al basale nell’uso dell’ossigenazione
    • Variazioni rispetto al basale nell’utilizzo della ventilazione meccanica o dell’ossigenazione extracorporea a membrana (ECMO)
    • Valutare il miglioramento clinico utilizzando la scala del punteggio di allarme precoce pediatrico (PEWS) in partecipanti affetti da COVID-19 confermata in laboratorio di età compresa tra 0 giorni e < 18 anni
    • Determinare le esposizioni alla solfobutiletere-beta-ciclodestrina sodica (SBECD) (ove possibile)
    • Fornire dati sull’utilizzo di farmaci diversi da RDV per il trattamento di COVID-19
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Willing and able to provide assent or a parent or legal guardian willing and able to provide written informed consent (participants < 18 years of age, where locally and nationally approved) prior to performing study procedures.
    2) Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board [IRB] or independent ethics committee [IEC]).
    a) Cohort 1: = 12 years to < 18 years of age and weight at screening = 40 kg
    b) Cohorts 2-4: = 28 days to < 18 years of age and weight at screening =3 kg and < 40 kg
    c) Cohort 5: = 14 days to <28 days of age, gestational age > 37 weeks and weight at screening = 2.5 kg
    d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of = 2.5 kg
    e) Cohort 7: 0 days to < 56 days of age, gestational age = 37 weeks and birth weight of = 1.5 kg
    3) SARS-CoV-2 infection confirmed by PCR
    4) Hospitalized and requiring medical care for COVID-19
    1) Soggetti disposti e in grado di fornire l’assenso o un genitore o tutore legale disposto e in grado di fornire il consenso informato scritto prima di eseguire le procedure dello studio.
    2) Età < 18 anni, che soddisfano uno dei seguenti criteri di peso.
    a) Coorte 1: da = 12 anni a < 18 anni di età e peso allo screening = 40 kg
    b) Coorti 2-4: da = 28 giorni a < 18 anni di età e peso allo screening da = 3 kg a < 40 kg
    c) Coorte 5: da = 14 giorni a < 28 giorni di età, età gestazionale > 37 settimane e peso allo screening = 2,5 kg
    d) Coorte 6: da 0 giorni a < 14 giorni di età, età gestazionale > 37 settimane e peso alla nascita = 2,5 kg
    e) Coorte 7: da 0 giorni a < 56 giorni di età, età gestazionale = 37 settimane e peso alla nascita = 1,5 kg
    3) Infezione da SARS-CoV-2 confermata da PCR
    4) Ricoverati in ospedale e che richiedono cure mediche per COVID-19
    E.4Principal exclusion criteria
    1) Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
    2) ALT or AST > 5 X ULN
    3) eGFR < 30 mL/min using Schwartz formula for participants = 1 year of age
    4)Creatinine above thresholds as described in (see table in Page 27) Protocol for < 1 year of age
    5) If < 28 days of age, any major congenital renal anomaly
    6) If < 24 hours of age, Apgar score < 5 at 10 minutes
    7) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
    1) Trattamento concomitante con altri agenti con effettiva o possibile attività antivirale diretta contro SARS-CoV-2 < 24 ore prima della dose del farmaco sperimentale
    2) ALT o AST > 5 x il limite superiore della norma (ULN)
    3) Velocità di filtrazione glomerulare stimata (eGFR) < 30 ml/min utilizzando la formula di Schwartz per i partecipanti = 1 anno di età
    4) Creatinina superiore alle soglie della tabella riportata di seguito per < 1 anno di età
    5) Se < 28 giorni di età, qualsiasi anomalia renale congenita maggiore
    6) Se < 24 ore di età, indice di Apgar < 5 a 10 minuti
    7) 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 with treatment-emergent adverse events (TEAEs).
    • The proportion of participants with treatment-emergent graded laboratory abnormalities.
    • PK assessed by plasma concentrations of RDV and metabolites.
    • Incidenza degli eventi avversi (EA) emergenti dal trattamento
    • Incidenza emergente dal trattamento dei valori clinici anomali di laboratorio
    • PK valutata mediante concentrazioni plasmatiche di RDV e metaboliti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Summary of descriptive statistics for each endpoint
    Riassunto delle statistiche descrittive di ciascun endpoint
    E.5.2Secondary end point(s)
    • Oxygen usage and ventilation modality and settings
    • Clinical improvement based on scoring using the 7-point Ordinal Scale
    • Time (days) to discharge from hospital
    • Days to the first confirmed negative PCR result, where confirmed is defined as 2 consecutive negative PCR results
    • Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first confirmed negative PCR result (whichever comes first)
    • Bilirubin concentrations in < 14-day-old participants
    • Clinical improvement based on scoring using the PEWS Improvement Scale
    Plasma concentrations of SBECD (where possible)
    • The proportion of participants with concomitant use of medications other than RDV for treatment of COVID-19
    • Necessità di ossigeno e ventilazione meccanica
    • Punteggio clinico su Scala ordinale a 7 punti
    • Tempo (giorni) alla dimissione dall’ospedale
    • Giorni al primo risultato negativo alla PCR confermato, dove per “confermato” si intendono 2 risultati negativi alla PCR consecutivi
    • Variazione rispetto al basale nel carico virale di SARS-CoV-2 fino al Giorno 10 o fino al primo risultato negativo alla PCR confermato (a seconda di quale evento si verifichi prima)
    • Concentrazioni di bilirubina nei partecipanti < 14 giorni
    • Miglioramento clinico basato sul punteggio della Scala di miglioramento PEWS
    • Proporzione di partecipanti con uso concomitante di farmaci diversi da RDV per il trattamento di COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    Summary of descriptive statistics for each endpoint
    Riassunto delle statistiche descrittive di ciascun endpoint
    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 Yes
    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) Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Braccio singolo
    -
    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
    -
    -
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    Spain
    United Kingdom
    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
    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 days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 4
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 24
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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
    Ability to provide assent or a parent or legal guardian willing and able to provide written informed consent for participants < 18 years of age, where locally and nationally approved prior to performing study procedures.
    Ability to provide assent or a parent or legal guardian willing and able to provide written informed consent for participants < 18 years of age, where locally and nationally approved prior to performing study procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 52
    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.
    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 Decision2020-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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