Trial · NCT05715528
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | Percentage of Participants With Viral Antigen Rebound | 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. |
| Secondary | Plasma Concentrations of GS-441524 (Metabolite of Obeldesivir) | Day 1, 0.75 hour and 2 hours; Day 3, Predose and 0.75 hour; Day 5, Predose and 0.75 hour | |
| Secondary | Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524 | Day 5 | AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady-state. |
| Secondary | PK Parameter: Ctau of GS-441524 | Day 1 and Day 5 | Ctau is defined as the observed drug concentration at the end of the dosing interval. |
| Secondary | PK Parameter: Cmax of GS-441524 | Day 1 and Day 5 | Cmax is defined as the maximum observed plasma concentration of drug. |
| Secondary | Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29 | Up to Day 29 | Symptom relapse means at least 2 consecutive diary entries (regardless of missing data in between) where there was any symptom (regardless of severity) OR a hospitalization for COVID-19 or a death after short symptom recovery. Percentages were rounded off. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05715528/registered