COVID-19Phase 2/3NCT05996744
Study of Obeldesivir in Children and Adolescents With COVID-19
A Phase 2/3 study testing Obeldesivir in people with COVID-19, run by Gilead Sciences at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Obeldesivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Dec 2023to 23 Feb 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Velocity Clinical Research -Albuquerque
Albuquerque, New Mexico, 87107
Advanced Research Center, Inc.
Anaheim, California, 92805
PanAmerican Clinical Research, LLC
Brownsville, Texas, 78520
Trinity Clinical Research, LLC
Centreville, Alabama, 35042
Velocity Clinical Research, Charleston
Charleston, South Carolina, 29414
Child Health Care Associates
East Syracuse, New York, 13057
UF Health- Shands Hospital
Gainesville, Florida, 32610
Encore Medical Research LLC
Hollywood, Florida, 33021
Texas Children's Hospital
Houston, Texas, 77030
The University of Texas Medical School at Houston
Houston, Texas, 77030
Pas Research
Las Vegas, Nevada, 89128
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Accel Research Sites Network - Nona Pediatric Center
Orlando, Florida, 32829
Stanford University Medical Center
Palo Alto, California, 94304
Avanza Medical Research Center
Pensacola, Florida, 32503
Santos Research Center
Tampa, Florida, 33603
Pas Research
Tampa, Florida, 33613
About this study
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
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.
Read the 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
- Conditions
- COVID-19
- Being tested
- Obeldesivir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeldesivirDrug
Also called GS-5245
Tablet administered orally with or without food
| Study group | Role | What they receive |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Experimental | Participants received ODV tablets (350 mg twice daily) for 5 days. Receives: Drug: Obeldesivir |
| ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg | Experimental | Participants received ODV tablets (175 mg twice daily) for 5 days. Receives: Drug: Obeldesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Measured: 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
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.
Measured: First dose date up to Day 35
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by 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.
Measured: First dose date up to Day 35
Secondary outcomes (7)
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by 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.
Measured: First dose date up to Day 35
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Nasal swab samples will be used to assess SARS-CoV-2 viral load.
Measured: Baseline, Day 5
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.
Measured: First dose date up to Day 35
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.
Measured: Day 5
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
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.
Measured: Day 5
Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
Measured: First dose date up to Day 35
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
Measured: First dose date up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start26 Dec 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Why it stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996744
- Sponsor's protocol ID
- GS-US-611-6464
- Other IDs
- 2023-503282-27, 2023
- Status last verified
- Jan 2025
- First submitted
- 14 Aug 2023
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05996744
- Acronym / sponsor ID
- GS-US-611-6464
- Conditions
- COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg | Experimental | Drug: ObeldesivirParticipants 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 | Experimental | Drug: ObeldesivirParticipants received ODV tablets (175 mg twice daily) for 5 days. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObeldesivirAlso: GS-5245Tablet administered orally with or without food | Drug | ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg, Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg |
Primary outcome
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
Time frame: First dose date up to Day 35
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
Time frame: Baseline, Day 5
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
Time frame: First dose date up to Day 35
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Time frame: Day 5
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Time frame: Day 5
Percentage 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
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
Time frame: First dose date up to Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Obeldesivir in people with COVID-19, run by Gilead Sciences at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV) (time frame: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.