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Study of Obeldesivir in Children and Adolescents With COVID-19

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Obeldesivir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Encore Medical Research LLCRecruiting
  • Accel Research Sites Network - Nona Pediatric CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Obeldesivir (ODV)

Arm Description

Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows: Cohort 1: ODV, tablets, 350 mg twice daily (BID) Cohort 2: ODV, tablets, 175 mg BID Cohorts 3-7: ODV doses will be determined based on available PK data.

Outcomes

Primary Outcome Measures

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.
PK Parameter: Cmax of ODV Metabolite, GS-441524
Cmax is defined as maximum observed concentration of drug.
PK Parameter: Ctrough of ODV Metabolite, GS-441524
Ctrough is defined as concentration at the end of the dosing interval.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35

Secondary Outcome Measures

Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Proportion of Participants Who Require Supplemental Oxygen Support by Day 35
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.
Proportion of Participants with Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35

Full Information

First Posted
August 14, 2023
Last Updated
October 5, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05996744
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obeldesivir (ODV)
Arm Type
Experimental
Arm Description
Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows: Cohort 1: ODV, tablets, 350 mg twice daily (BID) Cohort 2: ODV, tablets, 175 mg BID Cohorts 3-7: ODV doses will be determined based on available PK data.
Intervention Type
Drug
Intervention Name(s)
Obeldesivir
Other Intervention Name(s)
GS-5245
Intervention Description
Tablet administered orally with or without food
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524
Description
AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.
Time Frame
Cohorts 1 and 2: Day 3 and 5
Title
PK Parameter: Cmax of ODV Metabolite, GS-441524
Description
Cmax is defined as maximum observed concentration of drug.
Time Frame
Cohorts 1 and 2: Day 3 and 5
Title
PK Parameter: Ctrough of ODV Metabolite, GS-441524
Description
Ctrough is defined as concentration at the end of the dosing interval.
Time Frame
Cohorts 1 and 2: Day 3 and 5
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
Time Frame
First dose date up to Day 5 plus 30 days
Title
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
Time Frame
First dose date up to Day 5 plus 30 days
Secondary Outcome Measure Information:
Title
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
Time Frame
First dose date up to Day 35
Title
Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Time Frame
Baseline, Day 5
Title
Proportion of Participants Who Require Supplemental Oxygen Support by Day 35
Time Frame
First dose date up to Day 35
Title
Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores
Description
Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.
Time Frame
Day 5
Title
Proportion 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
Title
Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35
Time Frame
First dose date up to Day 35

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Encore Medical Research LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Network - Nona Pediatric Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study?nctid=NCT05996744
Description
Gilead Clinical Trials Website

Learn more about this trial

Study of Obeldesivir in Children and Adolescents With COVID-19

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