Study of Obeldesivir in Children and Adolescents With COVID-19

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

The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).

The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Obeldesivir

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Centreville, Alabama, United States, 35042
      • Trinity Clinical Research, LLC
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health- Shands Hospital
    • Hollywood, Florida, United States, 33021
      • Encore Medical Research LLC
    • Orlando, Florida, United States, 32829
      • Accel Research Sites Network - Nona Pediatric Center
    • Pensacola, Florida, United States, 32503
      • Avanza Medical Research Center
    • Tampa, Florida, United States, 33613
      • PAS Research
    • Tampa, Florida, United States, 33603
      • Santos Research Center
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Velocity Clinical Research, Norfolk
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • PAS Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • Velocity Clinical Research -Albuquerque
  • New York
    • East Syracuse, New York, United States, 13057
      • Child Health Care Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Velocity Clinical Research, Charleston
  • Texas
    • Brownsville, Texas, United States, 78520
      • PanAmerican Clinical Research, LLC
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas Medical School at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg; Participants received ODV tablets (350 mg twice daily) for 5 days.	Drug: Obeldesivir; Tablet administered orally with or without food; Other Names: GS-5245
Experimental: ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg; Participants received ODV tablets (175 mg twice daily) for 5 days.	Drug: Obeldesivir; Tablet administered orally with or without food; Other Names: GS-5245

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)		Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35	Treatment-emergent adverse events are defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; Any AEs leading to premature discontinuation of study drug.	First dose date up to Day 35
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35	Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days participants who permanently discontinued study drug.	First dose date up to Day 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35	The time to sustained alleviation of targeted COVID-19 symptoms will be calculated as the last date on which the symptom alleviation is assessed by Day 35 minus the first dose date plus 1 day or Day 34, whichever occurs first. Symptom alleviation is defined as follows: all targeted symptoms scored moderate or severe at baseline are scored as mild or none for at least 48 consecutive hours, and all targeted symptoms scored mild or none at baseline are scored as none for at least 48 consecutive hours; the first day of the 48 consecutive hours will be considered the symptom alleviation date. Targeted symptoms include: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, and nausea.	First dose date up to Day 35
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5	Nasal swab samples will be used to assess SARS-CoV-2 viral load.	Baseline, Day 5
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35	Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.	First dose date up to Day 35
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants	A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.	Day 5
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants	A questionnaire was administered to participants to assess the acceptability of the formulation. Acceptability was assessed by questions about the size of the drug and how easy it was to swallow the study drug.	Day 5
Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35		First dose date up to Day 35
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35		First dose date up to Day 35

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2023
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: GS-US-611-6464; 2023-503282-27 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No