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Study of Obeldesivir in Children and Adolescents With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05996744
Recruitment Status : Not yet recruiting
First Posted : August 18, 2023
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Obeldesivir Phase 2 Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : June 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Obeldesivir (ODV)

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.
 Drug: Obeldesivir
Tablet administered orally with or without food
Other Name: GS-5245


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]
    AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.

  2. PK Parameter: Cmax of ODV Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]
    Cmax is defined as maximum observed concentration of drug.

  3. PK Parameter: Ctrough of ODV Metabolite, GS-441524 [ Time Frame: Cohorts 1 and 2: Day 3 and 5 ]
    Ctrough is defined as concentration at the end of the dosing interval.

  4. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35 [ Time Frame: First dose date up to Day 5 plus 30 days ]
  5. 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 Measures :
  1. Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35 [ Time Frame: First dose date up to Day 35 ]
  2. Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5 [ Time Frame: Baseline, Day 5 ]
  3. Proportion of Participants Who Require Supplemental Oxygen Support by Day 35 [ Time Frame: First dose date up to Day 35 ]
  4. Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores [ Time Frame: Day 5 ]
    Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.

  5. 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 ]
  6. Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35 [ Time Frame: First dose date up to Day 35 ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996744


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05996744    
Other Study ID Numbers: GS-US-611-6464
2023-503282-27 ( Other Identifier: European Medicines Agency )
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases