Trial · NCT05715528
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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 |
| SECONDARY | Percentage of Participants With Viral Antigen Rebound | Up to Day 29 | Participants from Antigen Analysis Set with antigen negativity were included. | percentage of participants | NUMBER |
| 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 | The Pharmacokinetic (PK) Analysis Set included all randomized participants, who took at least 1 dose of study drug and had at least 1 non-missing concentration value reported by the PK laboratory for GS-441524.~Participants with available data were analyzed. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic (PK) Parameter: AUCtau,Steady-State of GS-441524 | Day 5 | The Intensive PK Substudy analysis set included all randomized participants, who took at least 1 dose of study drug, participated in the intensive PK substudy, and had at least 1 non-missing concentration for GS-441524, excluding participants with identified outliers, were analyzed. | h*ng/mL | MEAN |
| SECONDARY | PK Parameter: Ctau of GS-441524 | Day 1 and Day 5 | Participants from Intensive PK Substudy Analysis Set excluding participants with identified outliers, were analyzed. | ng/mL | MEAN |
| SECONDARY | PK Parameter: Cmax of GS-441524 | Day 1 and Day 5 | Participants from Intensive PK Substudy Analysis Set excluding participants with identified outliers, were analyzed. | ng/mL | MEAN |
| SECONDARY | Percentage of Participants With Relapse of COVID-19 Symptoms by Day 29 | Up to Day 29 | Participants in the Full Analysis Positive Set with available data were analyzed. | percentage of participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT05715528/outcomes