Study of Obeldesivir in Children and Adolescents With COVID-19

NCT ID: NCT05996744

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-26
• Study Completion Date: 2024-02-23

Brief Summary

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.

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

Conditions

COVID-19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Obeldesivir

Intervention Type: DRUG

Tablet administered orally with or without food

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.

Group Type: EXPERIMENTAL

Obeldesivir

Intervention Type: DRUG

Tablet administered orally with or without food

Interventions

Obeldesivir

Tablet administered orally with or without food

Intervention Type: DRUG

Other Intervention Names

GS-5245

Eligibility Criteria

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.

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Trinity Clinical Research, LLC

Centreville, Alabama, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Stanford University Medical Center

Palo Alto, California, United States

UF Health- Shands Hospital

Gainesville, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Accel Research Sites Network - Nona Pediatric Center

Orlando, Florida, United States

Avanza Medical Research Center

Pensacola, Florida, United States

Santos Research Center

Tampa, Florida, United States

Pas Research

Tampa, Florida, United States

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States

Pas Research

Las Vegas, Nevada, United States

Velocity Clinical Research -Albuquerque

Albuquerque, New Mexico, United States

Child Health Care Associates

East Syracuse, New York, United States

Velocity Clinical Research, Charleston

Charleston, South Carolina, United States

PanAmerican Clinical Research, LLC

Brownsville, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

The University of Texas Medical School at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study?nctid=NCT05996744

Gilead Clinical Trials Website

Other Identifiers

2023-503282-27

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-611-6464

Identifier Type: -

Identifier Source: org_study_id