Clinical trial NCT05996744: Study of Obeldesivir in Children and Adolescents With COVID-19
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 3
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
timeFrame: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
timeFrame: First dose date up to Day 35
measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
timeFrame: First dose date up to Day 35
Secondary outcomes:
measure: Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
timeFrame: First dose date up to Day 35
measure: Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
timeFrame: Baseline, Day 5
measure: Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
timeFrame: First dose date up to Day 35
measure: Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
timeFrame: Day 5
measure: Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
timeFrame: Day 5
measure: Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
timeFrame: First dose date up to Day 35
measure: Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
timeFrame: First dose date up to Day 35
Other outcomes:
Locations:
city: Centreville
country: United States
facility: Trinity Clinical Research, LLC
state: Alabama
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Gainesville
country: United States
facility: UF Health- Shands Hospital
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research LLC
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites Network - Nona Pediatric Center
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Tampa
country: United States
facility: Pas Research
state: Florida
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Pas Research
state: Nevada
city: Albuquerque
country: United States
facility: Velocity Clinical Research -Albuquerque
state: New Mexico
city: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Charleston
country: United States
facility: Velocity Clinical Research, Charleston
state: South Carolina
city: Brownsville
country: United States
facility: PanAmerican Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Medical School at Houston
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: