Clinical Trials Register

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	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.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-001803-17

A.3

Full 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.3.1

Title 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.3.2

Name 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.4.1

Sponsor's protocol code number

GS-US-540-5823

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/201/2020

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GILEAD SCIENCES INCORPORATED
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Gilead Sciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gilead Sciences International Ltd.
B.5.2	Functional name of contact point	Clinical Trials Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Flowers Building, Granta Park
B.5.3.2	Town/ city	Great Abington, Cambridge
B.5.3.3	Post code	CB21 6GT
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441223897284
B.5.5	Fax number	000000
B.5.6	E-mail	clinical.trials@gilead.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Remdesivir
D.3.2	Product code	[GS-5734]
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	REMDESIVIR
D.3.9.2	Current sponsor code	GS-5734
D.3.9.4	EV Substance Code	SUB195655
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Coronavirus disease 2019 (COVID-19)

Infezione da coronavirus 2019 (COVID-19)

E.1.1.1

Medical condition in easily understood language

Coronavirus disease 2019 (COVID-19)

Infezione da coronavirus 2019 (COVID-19)

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.5.1.1

Timepoint(s) of evaluation of this end point

Summary of descriptive statistics for each endpoint

Riassunto delle statistiche descrittive di ciascun endpoint

E.5.2

Secondary 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.5.2.1

Timepoint(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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Braccio singolo

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If 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.8.7

Trial 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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details 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.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-21

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials