Study Evaluating GS-5245 in Nonhospitalized Participants With COVID-19
Study Details
Study Description
Brief Summary
The goal of this study is to test if GS-5245 is safe and effective for the treatment of COVID-19 in participants who have a standard risk of developing severe illness. The study will also measure how much GS-5245 gets into the blood and how long it takes for the body to get rid of it.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GS-5245 Participants will receive GS-5245 350 mg twice daily for 5 days. |
Drug: GS-5245
Tablet administered orally without regard to food.
|
| Placebo Comparator: GS-5245 Placebo Participants will receive GS-5245 placebo twice daily for 5 days. |
Drug: GS-5245 Placebo
Tablet administered orally without regard to food.
|
Outcome Measures
Primary Outcome Measures
- Time to Coronavirus Disease 2019 (COVID-19) Symptom Alleviation by Day 29 [First dose date up to Day 29]
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [First dose date up to Day 5 plus 30 days]
- Percentage of Participants Experiencing Laboratory Abnormalities [First dose date up to Day 5 plus 30 days]
- 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]
Secondary Outcome Measures
- Time to COVID-19 Symptom Resolution by Day 29 [Day 1 up to 29]
- Proportion of Participants with COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29 [Up to Day 29]
- Proportion of Participants with Moderate Relapse of COVID-19 Symptoms by Day 29 [Up to Day 29]
- Proportion of Participants with COVID-19-related Hospitalization or All-cause Death by Day 29 [Up to Day 29]
- Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Nasal Swab Viral Load at Day 5 [Baseline, Day 5]
- Time to Antigen Negativity [Day 1 up to Day 29]
- Proportion of Participants with Viral Antigen Rebound [First dose date up to Day 29]
- Plasma Concentrations of GS-441524 (Metabolite of GS-5425) [Day 1, Day 3, and Day 5]
- Pharmacokinetic (PK) Parameter: AUCtau of GS-441524 [Day 1, Day 3, and Day 5]
AUCtau is defined as the area under the concentration versus time curve over the dosing interval
- PK Parameter: Ctau of GS-441524 [Day 1, Day 3, and Day 5]
Ctau is defined as the observed drug concentration at the end of the dosing interval
- PK Parameter: Cmax of GS-441524 [Day 1, Day 3, and Day 5]
Cmax is defined as the maximum observed plasma concentration of drug
- Proportion of Participants with Relapse of COVID-19 Symptoms by Day 29 [Up to Day 29]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed, ≤ 3 days before randomization, by polymerase chain reaction (PCR), rapid antigen test, or an alternative validated assay.
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Willing and able to complete the coronavirus disease 19 (COVID-19) symptom questionnaire prior to first dose and daily throughout the study period.
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Initial onset of COVID-19 signs/symptoms ≤ 3 days before randomization with ≥ 2 of the following targeted symptoms, at moderate or higher severity, present at randomization.
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Stuffy or runny nose.
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Sore throat.
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Shortness of breath (difficulty breathing).
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Cough.
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Low energy or tiredness.
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Muscle or body aches.
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Headache.
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Chills or shivering.
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Feeling hot or feverish.
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Not currently hospitalized or requiring hospitalization.
Key Exclusion Criteria:
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Any risk factors for progression to severe disease.
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Planning to receive a direct acting antiviral or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19.
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Received any direct acting antiviral drug or monoclonal antibody against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
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Received any convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 prophylaxis at any time prior to study entry.
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Received an COVID-19 vaccine (including booster dose) < 4 months before randomization.
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Self-reported COVID-19 diagnosis < 4 months before randomization.
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Anticipated need for hospitalization < 48 hours after randomization.
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New oxygen requirement < 24 hours before randomization.
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Suspected or confirmed concurrent active systemic infection (including influenza) other than COVID-19 that may interfere with the evaluation of response to the study drug.
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Known history of chronic liver disease, limited to cirrhosis, nonalcoholic fatty liver disease, alcoholic liver disease, and autoimmune hepatitis.
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Undergoing dialysis, or known history of chronic kidney disease.
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Prior diagnosis of post-acute sequelae of COVID-19 (PASC) or long COVID.
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Pregnant or breastfeeding.
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Unwilling to use protocol-mandated contraception.
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Any other factor, including inability to complete the patient-reported outcome (PRO) questionnaire for the primary endpoint, making the individual, in the opinion of the investigator, unsuitable to participate in the study.
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Concurrent participation/enrollment in a separate therapeutic clinical study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-US-611-6549
- 2023-503277-38-00