Trial · NCT05715528
Study of Obeldesivir in Nonhospitalized Participants With COVID-19
NCT05715528, Phase 3, Completed, Gilead Sciences; results first posted 2024-12-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Obeldesivir in Nonhospitalized Participants With COVID-19. Trials, record NCT05715528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05715528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Obeldesivir in Nonhospitalized Participants With COVID-19
- NCT number
- NCT05715528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,011 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- COVID-19
- Interventions
- Obeldesivir, Obeldesivir Placebo
- First posted
- 2023-02-08
- Last updated
- 2024-12-24
- Results first posted
- 2024-12-24
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 | 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 scored as mild/none and all targeted symptoms scored mild/none at baseline were scored as none, for at least 48 consecutive hours. Targeted symptoms included: stuffy or runny nose, sore throat, shortness of breath, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering and feeling hot or feverish. Kaplan-Meier (KM) estimates were used in outcome measure analysis. |
| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | 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. |
| Primary | Percentage of Participants Experiencing Laboratory Abnormalities | 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. |
| Primary | Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | First dose date up to Day 5 plus 30 days | Percentages were rounded off. |
| Secondary | Time to COVID-19 Symptom Resolution by Day 29 | 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. |
| Secondary | Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29 | 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. |
| Secondary | Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29 | 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. |
| Secondary | Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29 | 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 reason for hospitalization (including if the hospitalization was related to COVID-19) was to be recorded. Percentages were rounded off. |
| Secondary | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 | Day 5 | |
| Secondary | Time to Antigen Negativity | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 | First dose date up to Day 29 | The Full Analysis Positive Set (FAPS) included all participants, except from one of the site which did not comply with study rules, who were randomized into the study, have received at least 1 dose of study drug, and were SARS-CoV-2 positive at baseline as confirmed by Cepheid's Xpert Xpress CoV-2/Flu/RSV plus test or SARS-CoV-2 reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) test from central lab.~Participants with available data were analyzed. | days | MEDIAN |
| PRIMARY | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to Day 5 plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Laboratory Abnormalities | First dose date up to Day 5 plus 30 days | Participants from the Safety Analysis Set who had available postbaseline data were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | First dose date up to Day 5 plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Time to COVID-19 Symptom Resolution by Day 29 | Day 1 up to 29 | Participants in the Full Analysis Positive Set with available data were analyzed. | days | MEDIAN |
| SECONDARY | Percentage of Participants With Moderate Relapse of COVID-19 Symptoms by Day 29 | Up to Day 29 | Participants in the Full Analysis Positive Set who had short symptom recovery with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With COVID-19 Related Medically Attended Visits (MAVs) or All-cause Death by Day 29 | Up to Day 29 | Participants in the Full Analysis Positive Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With COVID-19 Related Hospitalization or All-cause Death by Day 29 | Up to Day 29 | Participants in the Full Analysis Positive Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 | Day 5 | The Virology Analysis Set included all participants, who were randomized into the study, had received at least 1 dose of study drug, and had a baseline SARS-CoV-2 viral load ≥ Lower limit of quantification (LLOQ).~Participants with available data were analyzed. | log10 copies/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Antigen Negativity | Day 1 up to Day 29 | The Antigen Analysis Set included all participants, who were randomized into the study, had received at least 1 dose of study drug, and had at least 1 SARS-CoV-2 rapid antigen test positive from Day 1 to Day 5 and SARS-CoV-2 polymerase chain reaction (PCR) positive at baseline per Full Analysis Positive Set. | days | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 | Obeldesivir | 5.9 | 95% Confidence Interval 5.4 to 6.1 | days | |
| Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 | Placebo | 6.0 | 95% Confidence Interval 5.8 to 6.3 | days | |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Obeldesivir | 5.4 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Placebo | 5.7 | percentage of participants | ||
| Percentage of Participants Experiencing Laboratory Abnormalities | Obeldesivir | Any grade | 77.5 | percentage of participants | |
| Percentage of Participants Experiencing Laboratory Abnormalities | Placebo | Any grade | 78.5 | percentage of participants | |
| Percentage of Participants Experiencing Laboratory Abnormalities | Obeldesivir | Grade 3 or 4 | 6.1 | percentage of participants | |
| Percentage of Participants Experiencing Laboratory Abnormalities | Placebo | Grade 3 or 4 | 8.5 | percentage of participants | |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | Obeldesivir | SAEs | 0.2 | percentage of participants | |
| Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation | Placebo | SAEs | 0.4 | percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Obeldesivir | 1,005 | |
| Overall Study | STARTED | Placebo | 1,006 | |
| Overall Study | COMPLETED | Obeldesivir | 977 | |
| Overall Study | COMPLETED | Placebo | 963 | |
| Overall Study | NOT COMPLETED | Obeldesivir | 28 | |
| Overall Study | NOT COMPLETED | Placebo | 43 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Gastroenteritis bacterial | Infections and infestations | Obeldesivir | 1 | 979 | |
| serious | Gastroenteritis bacterial | Infections and infestations | Placebo | 0 | 976 | |
| serious | Transient ischaemic attack | Nervous system disorders | Obeldesivir | 0 | 979 | |
| serious | Transient ischaemic attack | Nervous system disorders | Placebo | 1 | 976 | |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Obeldesivir | 0 | 979 | |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 976 | |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Obeldesivir | 1 | 979 | |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo | 0 | 976 | |
| serious | Bipolar disorder | Psychiatric disorders | Obeldesivir | 0 | 979 | |
| serious | Bipolar disorder | Psychiatric disorders | Placebo | 1 | 976 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Obeldesivir | 0 | 1,005 |
| Total, all-cause mortality | Placebo | 0 | 1,006 |
| Total, other adverse events | Obeldesivir | 0 | 979 |
| Total, other adverse events | Placebo | 0 | 976 |
| Total, serious adverse events | Obeldesivir | 2 | 979 |
| Total, serious adverse events | Placebo | 4 | 976 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Obeldesivir vs Placebo: deaths from any cause | Trial comparisons |
| Obeldesivir vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05715528
GET https://conductscience.org/api/trials/v1/NCT05715528/results?page=2