Study of Obeldesivir in Children and Adolescents With COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05996744
• Other study ID #: GS-US-611-6464
• Secondary ID: 2023-503282-27
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: December 26, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: March 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Obeldesivir
Tablet administered orally with or without food

Locations

Country	Name	City	State
United States	Velocity Clinical Research -Albuquerque	Albuquerque	New Mexico
United States	Advanced Research Center, Inc.	Anaheim	California
United States	PanAmerican Clinical Research, LLC	Brownsville	Texas
United States	Trinity Clinical Research, LLC	Centreville	Alabama
United States	Velocity Clinical Research, Charleston	Charleston	South Carolina
United States	Child Health Care Associates	East Syracuse	New York
United States	UF Health- Shands Hospital	Gainesville	Florida
United States	Encore Medical Research LLC	Hollywood	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	The University of Texas Medical School at Houston	Houston	Texas
United States	Pas Research	Las Vegas	Nevada
United States	Velocity Clinical Research, Norfolk	Norfolk	Nebraska
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Accel Research Sites Network - Nona Pediatric Center	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Avanza Medical Research Center	Pensacola	Florida
United States	Pas Research	Tampa	Florida
United States	Santos Research Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35		First dose date up to Day 5 plus 30 days
Primary	Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35		First dose date up to Day 5 plus 30 days
Secondary	Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35		First dose date up to Day 35
Secondary	Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5		Baseline, Day 5
Secondary	Proportion of Participants Who Require Supplemental Oxygen Support by Day 35		First dose date up to Day 35
Secondary	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
Secondary	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
Secondary	Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35		First dose date up to Day 35

External Links

•   Gilead Clinical Trials Website