Study of Obeldesivir in Children and Adolescents With COVID-19

NCT05996744 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-611-64642023-503282-27
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 18

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

• Percentage of Participants Who Require Supplemental Oxygen Support by Day 35

  First dose date up to Day 35

• Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants

  Day 5

• Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants

  Day 5

Study Arms (2)

Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg

EXPERIMENTAL

Participants received ODV tablets (350 mg twice daily) for 5 days.

Drug: Obeldesivir

ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg

EXPERIMENTAL

Participants received ODV tablets (175 mg twice daily) for 5 days.

Drug: Obeldesivir

Interventions

Obeldesivir DRUG

Tablet administered orally with or without food

Also known as: GS-5245

ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg; Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (18)

Trinity Clinical Research, LLC

Centreville, Alabama, 35042, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

UF Health- Shands Hospital

Gainesville, Florida, 32610, United States

Location

Encore Medical Research LLC

Hollywood, Florida, 33021, United States

Location

Accel Research Sites Network - Nona Pediatric Center

Orlando, Florida, 32829, United States

Location

Avanza Medical Research Center

Pensacola, Florida, 32503, United States

Location

Santos Research Center

Tampa, Florida, 33603, United States

Location

Pas Research

Tampa, Florida, 33613, United States

Location

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, 68701, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Pas Research

Las Vegas, Nevada, 89128, United States

Location

Velocity Clinical Research -Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Child Health Care Associates

East Syracuse, New York, 13057, United States

Location

Velocity Clinical Research, Charleston

Charleston, South Carolina, 29414, United States

Location

PanAmerican Clinical Research, LLC

Brownsville, Texas, 78520, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 18, 2023
• Study Start: December 26, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)