Study of Obeldesivir in Children and Adolescents With COVID-19
Purpose
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
- COVID-19
Eligibility
- Eligible Ages
- Under 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
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 Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05996744
- Status
- Terminated
- Sponsor
- Gilead Sciences
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