LAST UPDATED
February 03, 2025
Clinicaltrials.gov ID
CTSID
OVERVIEW
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
PROTOCOL 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.
View moreParticipation requirements
Age
0 - 18 years
Sex
All
Healthy Volunteers
No
Age
0 - 18 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
COVID-19
Gender
N/A
Date
December 2023 - February 2024
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
Obeldesivir
Eligibility information
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.
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.
Locations
Locations (18)
Trinity Clinical Research, LLC
Centreville, Alabama, United States, 35042
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Stanford University Medical Center
Palo Alto, California, United States, 94304
UF Health- Shands Hospital
Gainesville, Florida, United States, 32610
Accel Research Sites Network - Nona Pediatric Center
Orlando, Florida, United States, 32829
Avanza Medical Research Center
Pensacola, Florida, United States, 32503
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States, 68701
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States, 68134
Velocity Clinical Research -Albuquerque
Albuquerque, New Mexico, United States, 87107
Child Health Care Associates
East Syracuse, New York, United States, 13057
Velocity Clinical Research, Charleston
Charleston, South Carolina, United States, 29414
PanAmerican Clinical Research, LLC
Brownsville, Texas, United States, 78520
The University of Texas Medical School at Houston
Houston, Texas, United States, 77030
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