Study Evaluating GS-5245 in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

Sponsor

Gilead Sciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05603143

Collaborator

(none)

2,300

Enrollment

Locations

Arms

14.9

Anticipated Duration (Months)

255.6

Patients Per Site

17.2

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: GS-5245 Drug: GS-5245 Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 :

Nov 5, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GS-5245 Participants will receive GS-5245 350 mg twice daily for 5 days.	Drug: GS-5245 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.

Arm

Intervention/Treatment

Experimental: GS-5245

Participants will receive GS-5245 350 mg twice daily for 5 days.

Drug: GS-5245

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.

Outcome Measures

Primary Outcome Measures

Proportion of Coronavirus Disease 2019 (COVID-19)- Related Hospitalizations or All-cause Death by Day 29 [First dose date up to Day 29]

Secondary Outcome Measures

Percentage Of Participants With Treatment-Emergent Adverse Events [First dose date up to Day 5 plus 30 days]
Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities [First dose date up to Day 5 plus 30 days]
Proportion of Participants With All-cause Hospitalization by Day 29 [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 [First dose date up to Day 29]
Proportion of Participants With COVID-19-related MAVs by Day 29 [First dose date up to Day 29]
Proportion of Participants With All-cause Death at Day 29 [First dose date up to Day 29]
Time to Sustained Alleviation of Targeted COVID-19 Symptoms [First dose date up to Day 29]
Change From Baseline In Viral Load [Baseline, Day 5]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hamilton Medical Research Group	Hamilton	Canada	L8M 1K7
2	Dr. Anil K. Gupta Medicine Professional Corporation	Toronto	Canada	M9V 4B4
3	Vancouver ID Research and Care Centre Society	Vancouver	Canada	V6Z 2C9
4	Ginemedica OVO 21	Wroclaw	Poland	50414
5	ETG Lodz	Zgierz	Poland	95-100
6	"Prof. Dr. Matei Bals" National Institute for Infectious Diseases	Bucharest	Romania	021105
7	"Prof. Dr. Matei Bals" National Institute for Infectious Diseases	Bucharest	Romania	21105
8	County Hospital Caracal	Caracal	Romania	235200
9	Sibiu Emergency Clinical County Hospital	Sibiu	Romania	550253

Sponsors and Collaborators

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Gilead Clinical Trials Website

Publications

None provided.

Responsible Party:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT05603143

Other Study ID Numbers:

GS-US-611-6273
2022-002741-18

First Posted:

Nov 2, 2022

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 26, 2023