Adults 12 to 64, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29Primary· First dose date up to Day 29
The time to alleviation of targeted COVID-19 symptoms by Day 29 for participants with symptom alleviation, was calculated as symptom alleviation date/time minus first dose date/time. For participants who completed Day 29 of the study or discontinued from the study before Day 29 without symptom alleviation (censored) and without inter-current events, time was calculated as last date/time on which symptom alleviation was assessed minus the first dose date/time or Day 28, whichever occurred first. Symptom alleviation was defined as, all targeted symptoms scored moderate or severe at baseline were
Group
Value
95% CI
Obeldesivir
5.9
5.4 – 6.1
Placebo
6.0
5.8 – 6.3
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Primary· First dose date up to Day 5 plus 30 days
TEAEs were 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. Percentages were rounded off.
Group
Value
95% CI
Obeldesivir
5.4
Placebo
5.7
Percentage of Participants Experiencing Laboratory AbnormalitiesPrimary· First dose date up to Day 5 plus 30 days
Treatment-emergent laboratory abnormalities were 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.
Percentages were rounded off.
Any grade
Group
Value
95% CI
Obeldesivir
77.5
Placebo
78.5
Grade 3 or 4
Group
Value
95% CI
Obeldesivir
6.1
Placebo
8.5
Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug DiscontinuationPrimary· First dose date up to Day 5 plus 30 days
Percentages were rounded off.
SAEs
Group
Value
95% CI
Obeldesivir
0.2
Placebo
0.4
AEs leading to study drug discontinuation
Group
Value
95% CI
Obeldesivir
0.1
Placebo
0
Time to COVID-19 Symptom Resolution by Day 29Secondary· Day 1 up to 29
COVID-19 symptom resolution was defined as all targeted symptoms scored as none for at least 48 consecutive hours. The first day of the 48 consecutive hours was considered the date of symptom resolution. The time to COVID-19 symptom resolution was the time (expressed as days) from the first dose date/time to the date/time of symptom resolution.
KM estimates were used in the outcome measure analysis.
Group
Value
95% CI
Obeldesivir
9.2
8.9 – 10.0
Placebo
9.3
8.9 – 10.1
Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29Secondary· Up to Day 29
COVID-19 moderate symptom relapse was defined as having at least 1 symptom being moderate or severe OR at least 2 mild symptoms OR a hospitalization for COVID-19 or death, observed on a day during COVID-19 symptom relapse.
Percentages were rounded off.
Group
Value
95% CI
Obeldesivir
8.3
6.4 – 10.5
Placebo
9.0
7.1 – 11.3
Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29Secondary· Up to Day 29
Medically attended visits were defined as interactions with health care professionals other than study staff or designees including hospitalization; in-person emergency, urgent, or primary care visits; or any other in-person visit attended by the participant and a health care professional. The nature and cause of the visit were identified.
KM estimates were used in the outcome measure analysis. Percentages were rounded off.
Group
Value
95% CI
Obeldesivir
0.1
0.0 – 0.3
Placebo
0.2
0.0 – 0.5
Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29Secondary· Up to Day 29
COVID-19-related hospitalization was defined as ≥ 24 hours of acute care for a reason related to COVID-19, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with COVID-19. This included specialized acute medical care units within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution. The date and duration (if there was 1 day difference between the start date and end date) of hospital admission, and primary reaso
Group
Value
95% CI
Obeldesivir
0
Placebo
0
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5Secondary· Day 5
Group
Value
95% CI
Obeldesivir
-2.69
± 0.019
Placebo
-2.71
± 0.020
Time to Antigen NegativitySecondary· Day 1 up to Day 29
Time to antigen negativity was defined (in days) as the number of days to the first date of 2 consecutive dates achieving a negative result. Antigen negativity was defined as 2 consecutive negative SARS-CoV-2 rapid antigen test (regardless if there was missing data in between), or negative test at last available sample for participants who completed or discontinued from the study after at least 1 positive antigen test.
Group
Value
95% CI
Obeldesivir
5.0
3.0 – 6.0
Placebo
5.0
4.0 – 6.0
Percentage of Participants With Viral Antigen ReboundSecondary· Up to Day 29
Viral antigen rebound was defined as any positive SARS-CoV-2 rapid antigen test after antigen negativity.
Percentages were rounded off.
Group
Value
95% CI
Obeldesivir
1.5
0.8 – 2.6
Placebo
1.7
1.0 – 2.9
Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir)Secondary· Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour
Day 1 (0.75 h)
Group
Value
95% CI
Obeldesivir
2528.97
± 5633.223
Day 1 (2 h)
Group
Value
95% CI
Obeldesivir
2390.68
± 4763.877
Day 3 (Predose)
Group
Value
95% CI
Obeldesivir
1103.79
± 6500.997
Day 3 (0.75 h)
Group
Value
95% CI
Obeldesivir
3339.59
± 11353.578
Day 5 (Predose)
Group
Value
95% CI
Obeldesivir
2599.61
± 29678.065
Day 5 (0.75 h)
Group
Value
95% CI
Obeldesivir
4595.37
± 30772.089
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events and All-Cause Mortality: Up to 35 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT05996744 — Study of Obeldesivir in Children and Adolescents With COVID-19
· Phase 2, PHASE3
· terminated
NCT05603143 — Study of Obeldesivir in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
· Phase 3
· terminated
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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· Phase 1
· active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
· Phase 3
· active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes
· Phase 1
· recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
· Phase 2
· recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A
· Phase 3
· active not recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 24 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05715528.