Study of Obeldesivir in Children and Adolescents With COVID-19

Gilead Sciences

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Obeldesivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT05996744

2023-503282-27 (Other Identifier)

GS-US-611-6464

Details and patient eligibility

About

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.

Full 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

Enrollment: 3 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 per protocol.

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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Obeldesivir

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

Experimental group

Description:

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

Treatment:

Drug: Obeldesivir