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.

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 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Obeldesivir (ODV); Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows: Cohort 1: ODV, tablets, 350 mg twice daily (BID); Cohort 2: ODV, tablets, 175 mg BID; Cohorts 3-7: ODV doses will be determined based on available PK data.	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
Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524	AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.	Cohorts 1 and 2: Day 3 and 5
PK Parameter: Cmax of ODV Metabolite, GS-441524	Cmax is defined as maximum observed concentration of drug.	Cohorts 1 and 2: Day 3 and 5
PK Parameter: Ctrough of ODV Metabolite, GS-441524	Ctrough is defined as concentration at the end of the dosing interval.	Cohorts 1 and 2: Day 3 and 5
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35		First dose date up to Day 5 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35		First dose date up to Day 5 plus 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35		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		Baseline, Day 5
Proportion of Participants Who Require Supplemental Oxygen Support by Day 35		First dose date up to Day 35
Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores	Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.	Day 5
Proportion 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
Proportion 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 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; 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