Study Evaluating GS-5245 in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05603143|
Recruitment Status : Recruiting
First Posted : November 2, 2022
Last Update Posted : March 2, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: GS-5245 Drug: GS-5245 Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression|
|Actual Study Start Date :||November 5, 2022|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Participants will receive GS-5245 350 mg twice daily for 5 days.
Tablets administered orally without food.
Placebo Comparator: Placebo
Participants will receive GS-5245 placebo twice daily for 5 days.
Drug: GS-5245 Placebo
Placebo tablets administered orally without food.
- Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29 [ Time Frame: First dose date up to Day 29 ]
- Percentage Of Participants With Treatment-Emergent Adverse Events [ Time Frame: First dose date up to Day 5 plus 30 days ]
- Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities [ Time Frame: First dose date up to Day 5 plus 30 days ]
- Proportion of Participants With All-cause Hospitalization by Day 29 [ Time Frame: First dose date up to Day 29 ]
- Proportion of Participants With COVID-19-related Medically Attended Visits (MAVs) or All-cause Death by Day 29 [ Time Frame: First dose date up to Day 29 ]
- Proportion of Participants With COVID-19-related MAVs by Day 29 [ Time Frame: First dose date up to Day 29 ]
- Proportion of Participants With All-cause Death at Day 29 [ Time Frame: First dose date up to Day 29 ]
- Time to Sustained Alleviation of Targeted COVID-19 Symptoms [ Time Frame: First dose date up to Day 29 ]
- Change From Baseline In Viral Load [ Time Frame: Baseline, Day 5 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Willing and able to provide written informed consent.
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed with an assay ≤ 5 days before randomization.
- Initial onset of COVID-19 signs/symptoms ≤ 5 days before randomization.
- Not currently hospitalized or requiring hospitalization.
- Presence of ≥ 1 risk factor (if unvaccinated) or ≥ 2 risk factors (if vaccinated at any point) for progression to severe disease. Vaccinated individuals are eligible for enrollment only if it has been at least 4 months since the most recent dose, including boosters.
Key Exclusion Criteria:
- Anticipated use of COVID-19 therapies during the current COVID-19 illness.
- Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
- Anticipated need for hospitalization < 48 hours after randomization.
- New oxygen requirement < 24 hours before randomization.
- Cirrhosis or acute liver injury/failure.
- Undergoing dialysis, or history of moderate to severe renal impairment.
- Pregnant or breastfeeding (nursing).
- Unwilling to use protocol-mandated birth control.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05603143
|Contact: Gilead Clinical Study Information Center||1-833-445-3230 (GILEAD-0)||GileadClinicalTrials@gilead.com|
|Study Director:||Gilead Study Director||Gilead Sciences|
|Responsible Party:||Gilead Sciences|
|Other Study ID Numbers:||
2022-002741-18 ( EudraCT Number )
|First Posted:||November 2, 2022 Key Record Dates|
|Last Update Posted:||March 2, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases