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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Tablet administered orally with or without food
Trinity Clinical Research, LLC
Centreville, Alabama, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Time frame: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
Treatment-emergent adverse events are defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.
Time frame: First dose date up to Day 35
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days participants who permanently discontinued study drug.
Time frame: First dose date up to Day 35
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
The time to sustained alleviation of targeted COVID-19 symptoms will be calculated as the last date on which the symptom alleviation is assessed by Day 35 minus the first dose date plus 1 day or Day 34, whichever occurs first. Symptom alleviation is defined as follows: all targeted symptoms scored moderate or severe at baseline are scored as mild or none for at least 48 consecutive hours, and all targeted symptoms scored mild or none at baseline are scored as none for at least 48 consecutive hours; the first day of the 48 consecutive hours will be considered the symptom alleviation date. Targeted symptoms include: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, and nausea.
Time frame: First dose date up to Day 35
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Stanford University Medical Center
Palo Alto, California, United States
UF Health- Shands Hospital
Gainesville, Florida, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Accel Research Sites Network - Nona Pediatric Center
Orlando, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
Santos Research Center
Tampa, Florida, United States
Pas Research
Tampa, Florida, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
...and 8 more locations
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Nasal swab samples will be used to assess SARS-CoV-2 viral load.
Time frame: Baseline, Day 5
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.
Time frame: First dose date up to Day 35
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.
Time frame: Day 5
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
A questionnaire was administered to participants to assess the acceptability of the formulation. Acceptability was assessed by questions about the size of the drug and how easy it was to swallow the study drug.
Time frame: Day 5
Percentage 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
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
Time frame: First dose date up to Day 35