Study of Obeldesivir in Children and Adolescents With COVID-19
- Registration Number
- NCT05996744
- Lead Sponsor
- Gilead Sciences
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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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.
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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
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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.
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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.
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Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19 per protocol.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg Obeldesivir Participants received ODV tablets (350 mg twice daily) for 5 days. ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg Obeldesivir Participants received ODV tablets (175 mg twice daily) for 5 days.
- Primary Outcome Measures
Name Time Method Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) 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 First dose date up to 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.Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 First dose date up to 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.
- Secondary Outcome Measures
Name Time Method Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 First dose date up to 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.
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 Baseline, Day 5 Nasal swab samples will be used to assess SARS-CoV-2 viral load.
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35 First dose date up to Day 35 Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants Day 5 A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants Day 5 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.
Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35 First dose date up to Day 35 Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35 First dose date up to Day 35
Trial Locations
- Locations (17)
UF Health- Shands Hospital
🇺🇸Gainesville, Florida, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Trinity Clinical Research, LLC
🇺🇸Centreville, Alabama, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
Velocity Clinical Research, Norfolk
🇺🇸Norfolk, Nebraska, United States
Velocity Clinical Research -Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Accel Research Sites Network - Nona Pediatric Center
🇺🇸Orlando, Florida, United States
Pas Research
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research, Omaha
🇺🇸Omaha, Nebraska, United States
Child Health Care Associates
🇺🇸East Syracuse, New York, United States
Encore Medical Research LLC
🇺🇸Hollywood, Florida, United States
Santos Research Center
🇺🇸Tampa, Florida, United States
Velocity Clinical Research, Charleston
🇺🇸Charleston, South Carolina, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
The University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
PanAmerican Clinical Research, LLC
🇺🇸Brownsville, Texas, United States