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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
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 5, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage Of Participants With Treatment-Emergent Adverse Events [ Time Frame: First dose date up to Day 5 plus 30 days ]
  2. Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities [ Time Frame: First dose date up to Day 5 plus 30 days ]
  3. Proportion of Participants With All-cause Hospitalization by Day 29 [ Time Frame: First dose date up to Day 29 ]
  4. 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 ]
  5. Proportion of Participants With COVID-19-related MAVs by Day 29 [ Time Frame: First dose date up to Day 29 ]
  6. Proportion of Participants With All-cause Death at Day 29 [ Time Frame: First dose date up to Day 29 ]
  7. Time to Sustained Alleviation of Targeted COVID-19 Symptoms [ Time Frame: First dose date up to Day 29 ]
  8. Change From Baseline In Viral Load [ Time Frame: Baseline, Day 5 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

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


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Additional Information:

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT05603143    
Other Study ID Numbers: GS-US-611-6273
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

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases