Study of Obeldesivir in Children and Adolescents With COVID-19

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gilead Sciences Inc.

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

completed 6 Mar 2024

Decision date (initial)

2023-12-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Gilead Sciences, Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To evaluate the plasma pharmacokinetic (PK) of Obeldesivir (ODV; GS-5245) in pediatric participants with COVID-19
To evaluate the safety and tolerability of ODV in pediatric participants with COVID-19

Secondary objectives 6

1. To assess the impact of ODV on time to sustained alleviation of targeted COVID-19 symptoms in pediatric participants with COVID-19
2. To evaluate the antiviral activity of ODV on syndrome coronavirus 2 (SARS-CoV-2) nasal swab viral load in pediatric participants with COVID-19
3. To assess the impact of ODV on the requirement for supplemental oxygen in pediatric participants with COVID 19
4. To evaluate palatability and acceptability of ODV in pediatric participants with COVID-19
5. To provide data on the use of medications other than remdesivir and ODV for treatment of COVID-19 in pediatric participants with COVID-19
6. To assess the impact of ODV on COVID-19-related hospitalizations or all-cause death in pediatric participants with COVID-19

Conditions and MedDRA coding

COVID-19

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-236621-PIP20-23

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant or legal guardian willing and able to provide written informed consent prior to performing study procedures. Participants will provide assent, if possible, in accordance with local requirements and investigator’s discretion.
2. Aged < 18 years who meet one of the following weight criteria and gestational age (GA) criteria where applicable (where permitted according to local law and approved nationally and by relevant IRB or IEC): a) Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg b) Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg c) Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg d) Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg e) Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg f) Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg g) Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
3. SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
4. Initial onset of COVID-19 signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening.
5. Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19, including: a) obesity (body mass index > 95th percentile for age and sex) b) diabetes c) chronic lung disease (eg, asthma, interstitial lung disease) d) cardiac disease (eg, congenital heart disease) e) immunosuppressive disease or receipt of immunosuppressive therapies resulting in moderate or severe immunocompromise f) neurologic disorders (eg, epilepsy, convulsions, cerebral palsy) g) genetic conditions (eg, trisomy and other chromosomal abnormalities) h) medical complexity, including medical-related technological dependence that is not related to COVID-19 (eg, tracheostomy, positive pressure ventilation) i) other medical conditions that are deemed to be a risk factor by the investigator

Exclusion criteria 10

1. Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness < 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, intravenous RDV, monoclonal antibodies).
2. Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection < 4 months prior to screening.
3. Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before enrollment.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 (including influenza) that may interfere with the evaluation of response to the study intervention.
5. Any of the following abnormal laboratory results at screening: a. ALT ≥ 5 × ULN b. eGFR < 60 mL/min/1.73 m2 for ≥ 1 year of age c. Serum creatinine: > 2.0 mg/dL for < 48 hours of life; > 2 × ULN for age for ≥ 48 hours of life to 1 year of age (refer to table on page 35 of protocol)
6. Any major congenital renal anomaly for participants < 28 days of age.
7. Apgar score < 5 for participants < 24 hours of age.
8. Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
9. Positive pregnancy test prior to enrollment for female participants of childbearing potential
10. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3.1. of the protocol

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524
2. Incidence of treatment-emergent AEs by Day 35
3. Incidence of treatment-emergent laboratory abnormalities by Day 35

Secondary endpoints 6

1. Time to sustained alleviation of targeted COVID-19 symptoms by Day 35
2. Change from baseline in SARS-CoV-2 nasal swab viral load at Day 5
3. Proportion of participants who require supplemental oxygen support (low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation) by Day 35
4. Assessment of palatability and acceptability scores of each formulation at Day 5
5. Proportion of participants with concomitant use of medications other than remdesivir and ODV for treatment of COVID-19 by Day 35
6. Proportion of participants with COVID-19-related hospitalization or all-cause death by Day 35

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gilead Sciences Inc.

Sponsor organisation

Gilead Sciences Inc.

Address

333 Lakeside Drive

City

Foster City

Postcode

94404-1147

Country

United States

Scientific contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Third parties 10

Locations

5 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications