Trial Outcomes & Findings for Study of Obeldesivir in Children and Adolescents With COVID-19 (NCT NCT05996744)
NCT ID: NCT05996744
Last Updated: 2025-02-03
Results Overview
TERMINATED
PHASE2/PHASE3
3 participants
Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
2025-02-03
Participant Flow
Participants were enrolled at study sites in the United States. The study was terminated early after 3 participants were enrolled. The decision to terminate the study early was not due to any safety concerns.
Participant milestones
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
Participants 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
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Obeldesivir in Children and Adolescents With COVID-19
Baseline characteristics by cohort
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≥ 6 years to < 18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
|
3.57 log10 copies/mL
STANDARD_DEVIATION 0.991 • n=5 Participants
|
4.36 log10 copies/mL
STANDARD_DEVIATION NA • n=7 Participants
|
3.84 log10 copies/mL
STANDARD_DEVIATION 0.836 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)Population: All participants who enrolled in the study and received the study drug were included. Participants with available data and for whom plasma concentrations of GS-441524 were available were analyzed.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 3 (5 to 8 hours postdose)
|
1950 ng/mL
Standard Deviation 933
|
NA ng/mL
Standard Deviation NA
The plasma concentration was below the limit of quantification.
|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 5 (predose)
|
79.2 ng/mL
Standard Deviation 97.3
|
NA ng/mL
Standard Deviation NA
The plasma concentration was below the limit of quantification.
|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 5 (15 minutes postdose)
|
8.37 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
209 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 5 (30 minutes postdose)
|
14.5 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
—
|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 5 (1 hour postdose)
|
510 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
—
|
|
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
Day 5 (4 hours postdose)
|
1610 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
—
|
PRIMARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
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.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
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.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
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.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
|
3.4 Days
Standard Deviation 0.47
|
2.5 Days
Standard Deviation NA
Since only 1 participant was analyzed, SD cannot be calculated.
|
SECONDARY outcome
Timeframe: Baseline, Day 5Population: All participants who enrolled in the study and received the study drug were included.
Nasal swab samples will be used to assess SARS-CoV-2 viral load.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
|
-0.61 log10 copies/mL
Standard Deviation 0.868
|
NA log10 copies/mL
Standard Deviation NA
The viral load assay uses two markers, N1 and N2, to amplify two different regions of the SARS-CoV-2 genome. For the participant in Cohort 2 on Day 5, one marker yielded a positive result and the other a negative result, therefore the assay resulted in an error and the result is inconclusive. There was no numerical result derived on Day 5 for the Cohort 2 participant since the result was inconclusive.
|
SECONDARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
Supplemental oxygen support included low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Percentage of Participants Who Require Supplemental Oxygen Support by Day 35
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 5Population: All participants who enrolled in the study and received the study drug were included.
A questionnaire was administered to participants to assess the palatability of the formulation. Palatability was assessed by questions about how the study drug tasted.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
No Taste
|
1 Participants
|
0 Participants
|
|
Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Neutral Taste (Maybe Good or Maybe Bad)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 5Population: All participants who enrolled in the study and received the study drug were included.
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.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Easy to Swallow
|
1 Participants
|
0 Participants
|
|
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Super Easy to Swallow
|
1 Participants
|
0 Participants
|
|
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Hard to Swallow
|
0 Participants
|
1 Participants
|
|
Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants
Size: Okay
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 35Population: All participants who enrolled in the study and received the study drug were included.
Outcome measures
| Measure |
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
n=2 Participants
Participants 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
n=1 Participants
Participants received ODV tablets (175 mg twice daily) for 5 days.
|
|---|---|---|
|
Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER