Study of Obeldesivir in Children and Adolescents With COVID-19
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|ClinicalTrials.gov Identifier: NCT05996744|
Recruitment Status : Not yet recruiting
First Posted : August 18, 2023
Last Update Posted : September 8, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Obeldesivir||Phase 2 Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||September 2023|
|Estimated Primary Completion Date :||June 2027|
|Estimated Study Completion Date :||June 2027|
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:
Tablet administered orally with or without food
Other Name: GS-5245
- Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.
- PK Parameter: Cmax of ODV Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]Cmax is defined as maximum observed concentration of drug.
- PK Parameter: Ctrough of ODV Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]Ctrough is defined as concentration at the end of the dosing interval.
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 [ Time Frame: First dose date up to Day 5 plus 30 days ]
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 [ Time Frame: First dose date up to Day 5 plus 30 days ]
- Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 [ Time Frame: 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 [ Time Frame: Baseline, Day 5 ]
- Proportion of Participants Who Require Supplemental Oxygen Support by Day 35 [ Time Frame: First dose date up to Day 35 ]
- Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores [ Time Frame: Day 5 ]Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.
- Proportion of Participants with Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35 [ Time Frame: First dose date up to Day 35 ]
- Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35 [ Time Frame: First dose date up to Day 35 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996744
|Contact: Gilead Clinical Study Information Center||1-833-445-3230 (GILEAD-0)||GileadClinicalTrials@gilead.com|
|Study Director:||Gilead Study Director||Gilead Sciences|