Study of Obeldesivir in Nonhospitalized Participants With COVID-19
NCT05715528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2011
Last updated 2024-12-24
Summary
The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.
Conditions
Interventions
- DRUG
-
Obeldesivir
Tablet administered orally without regard to food.
- DRUG
-
Obeldesivir Placebo
Tablet administered orally without regard to food.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-08
- Primary Completion
- 2023-11-28
- Completion
- 2024-01-23
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
More Related Trials
-
Study in Participants With Early Stage Coronavirus Disease 2019 (COVID-19) to Evaluate the Safety, Efficacy, and Pharmacokinetics of Remdesivir Administered by Inhalation
NCT04539262 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
NCT05305547 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Understand the Effect and Safety of the Study Medicine PF-07817883 in Adults Who Have Symptoms of COVID-19 But Are Not Hospitalized
NCT05799495 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety of Molnupiravir (EIDD-2801) and Its Effect on Viral Shedding of SARS-CoV-2 (END-COVID)
NCT04405739 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
NCT05897541 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)
NCT04575597 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
NCT06585150 ·Status: TERMINATED ·Phase: PHASE2
-
Safety, Tolerability and Efficacy of Molnupiravir (EIDD-2801) to Eliminate Infectious Virus Detection in Persons With COVID-19
NCT04405570 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Obeldesivir as Postexposure Prophylaxis for Filovirus Diseases Virus Disease
NCT06682234 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of Obeldesivir in Children and Adolescents With COVID-19
NCT05996744 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Multinational Phase III Study of CS-8958 (MARVEL)
NCT00803595 ·Status: COMPLETED ·Phase: PHASE3
-
First-in-Human Study of Orally Administered GS-441524 for COVID-19
NCT04859244 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomised, Multi-centre, Double-blind, Phase 3 Study to Observe the Effectiveness, Safety and Tolerability of Molnupiravir Compared to Placebo Administered Orally to High-risk Adult Outpatients With Mild COVID-19 Receiving Local Standard of Care in South Africa
NCT05459532 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
NCT04745351 ·Status: TERMINATED ·Phase: PHASE3
-
Assessment of the Efficacy of Calcium Dobesilate vs. Placebo on SARS-CoV-2 Viral Load Amongst Outpatients With COVID-19.
NCT05305508 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
NCT05047601 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety of Molnupiravir (MK-4482) in Hospitalized Adult Participants With COVID-19 (MK-4482-001)
NCT04575584 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
NCT01314911 ·Status: COMPLETED ·Phase: NA
-
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
NCT02603952 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Remdesivir in Participants Below 18 Years Old With COVID-19
NCT04431453 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Phase 3 Randomized, Double-Blind Placebo Controlled, Multi-regional Trial to Evaluate the Efficacy and Safety of GT0918 for the Treatment of Mild to Moderate COVID-19 Male Patients
NCT04869228 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
NCT01610245 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
NCT04847622 ·Status: COMPLETED
-
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
NCT04709835 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting
NCT04396106 ·Status: TERMINATED ·Phase: PHASE2