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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05996744
Other study ID # GS-US-611-6464
Secondary ID 2023-503282-27
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date December 26, 2023
Est. completion date February 23, 2024

Study information

Verified date March 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Terminated
Enrollment 3
Est. completion date February 23, 2024
Est. primary completion date February 23, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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. 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Obeldesivir
Tablet administered orally with or without food

Locations

Country Name City State
United States Velocity Clinical Research -Albuquerque Albuquerque New Mexico
United States Advanced Research Center, Inc. Anaheim California
United States PanAmerican Clinical Research, LLC Brownsville Texas
United States Trinity Clinical Research, LLC Centreville Alabama
United States Velocity Clinical Research, Charleston Charleston South Carolina
United States Child Health Care Associates East Syracuse New York
United States UF Health- Shands Hospital Gainesville Florida
United States Encore Medical Research LLC Hollywood Florida
United States Texas Children's Hospital Houston Texas
United States The University of Texas Medical School at Houston Houston Texas
United States Pas Research Las Vegas Nevada
United States Velocity Clinical Research, Norfolk Norfolk Nebraska
United States Velocity Clinical Research, Omaha Omaha Nebraska
United States Accel Research Sites Network - Nona Pediatric Center Orlando Florida
United States Stanford University Medical Center Palo Alto California
United States Avanza Medical Research Center Pensacola Florida
United States Pas Research Tampa Florida
United States Santos Research Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524 AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours. Cohorts 1 and 2: Day 3 and 5
Primary PK Parameter: Cmax of ODV Metabolite, GS-441524 Cmax is defined as maximum observed concentration of drug. Cohorts 1 and 2: Day 3 and 5
Primary PK Parameter: Ctrough of ODV Metabolite, GS-441524 Ctrough is defined as concentration at the end of the dosing interval. Cohorts 1 and 2: Day 3 and 5
Primary Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 First dose date up to Day 5 plus 30 days
Primary Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35 First dose date up to Day 5 plus 30 days
Secondary Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 First dose date up to Day 35
Secondary Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 Baseline, Day 5
Secondary Proportion of Participants Who Require Supplemental Oxygen Support by Day 35 First dose date up to Day 35
Secondary Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability. Day 5
Secondary Proportion 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
Secondary Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35 First dose date up to Day 35
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