Official Title
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
Brief Summary

The goal of this clinical study is to learn more about the safety and tolerability ofobeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety andtolerability of ODV in pediatric participants with COVID-19.

Detailed Description

Pediatric participants will be enrolled as follows:

- Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg

- Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg

- Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg

- Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg

- Cohort 5: ≥ 14 days to < 28 days of age, gestational age (GA) ≥ 37 weeks and weight
≥ 2.5 kg

- Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg

- Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg

Terminated
COVID-19

Drug: Obeldesivir

Tablet administered orally with or without food
Other Name: GS-5245

Eligibility Criteria

Key Inclusion Criteria:

- Individual or legal guardian willing and able to provide written informed consent
prior to performing study procedures. Individuals will provide assent, if possible,
in accordance with local requirements and investigator's discretion.

- Aged < 18 years who meet one of the following weight criteria and gestational age
(GA) criteria where applicable:

- Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg

- Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg

- Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg

- Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg

- Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg

- Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg

- Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg

- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by
polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5
days before screening.

- Initial onset of coronavirus disease 2019 (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.

- Presence of ≥ 1 characteristic or underlying medical condition associated with an
increased risk of developing severe illness due to COVID-19 per protocol.

Key Exclusion Criteria:

- 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 remdesivir (RDV),
monoclonal antibodies).

- Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection < 4
months prior to screening.

- 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: 18 Years
Countries
United States
Locations

Trinity Clinical Research, LLC
Centreville 4054566, Alabama 4829764, United States

Advanced Research Center, Inc.
Anaheim 5323810, California 5332921, United States

Stanford University Medical Center
Palo Alto 5380748, California 5332921, United States

UF Health- Shands Hospital
Gainesville 4156404, Florida 4155751, United States

Encore Medical Research LLC
Hollywood 4158928, Florida 4155751, United States

Accel Research Sites Network - Nona Pediatric Center
Orlando 4167147, Florida 4155751, United States

Avanza Medical Research Center
Pensacola 4168228, Florida 4155751, United States

Santos Research Center
Tampa 4174757, Florida 4155751, United States

Pas Research
Tampa 4174757, Florida 4155751, United States

Velocity Clinical Research, Norfolk
Norfolk 5073965, Nebraska 5073708, United States

Velocity Clinical Research, Omaha
Omaha 5074472, Nebraska 5073708, United States

Pas Research
Las Vegas 5506956, Nevada 5509151, United States

Velocity Clinical Research -Albuquerque
Albuquerque 5454711, New Mexico 5481136, United States

Child Health Care Associates
East Syracuse 5116079, New York 5128638, United States

Velocity Clinical Research, Charleston
Charleston 4574324, South Carolina 4597040, United States

PanAmerican Clinical Research, LLC
Brownsville 4676740, Texas 4736286, United States

Texas Children's Hospital
Houston 4699066, Texas 4736286, United States

The University of Texas Medical School at Houston
Houston 4699066, Texas 4736286, United States

Gilead Study Director, Study Director
Gilead Sciences

Gilead Sciences
NCT Number
MeSH Terms
COVID-19