Study Summary
The goal of this study is to test if GS-5245 is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a high risk of developing serious or severe illness. The study will also measure how much GS-5245 gets into the blood and how long it takes the body to get rid of it.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: First dose date up to Day 5 plus 30 days
Baseline, Day 5
Change From Baseline In Viral Load
Day 29
COVID-19 Testing
Proportion of Participants With All-cause Death at Day 29
Proportion of Participants With All-cause Hospitalization by Day 29
Proportion of Participants With COVID-19-related MAVs by Day 29
Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29
Time to Sustained Alleviation of Targeted COVID-19 Symptoms
Day 30
Percentage Of Participants With Treatment-Emergent Adverse Events
Therapeutic procedure
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
GS-5245
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
2300 Total Participants · 2 Treatment Groups
Primary Treatment: GS-5245 · Has Placebo Group · Phase 3
GS-5245
Drug
Experimental Group · 1 Intervention: GS-5245 · Intervention Types: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: GS-5245 Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: first dose date up to day 5 plus 30 days
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,018 Previous Clinical Trials
754,099 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
320 Previous Clinical Trials
178,726 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have signs/symptoms of COVID-19.
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Conditions
Cancer Related
Treatments