Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
NCT Number: NCT06585150
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: RSV Infection
Interventions: DRUG: Obeldesivir|DRUG: Obeldesivir Placebo
Sponsor: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09

Summary:
The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV; GS-5245), and how safe and effective it is in treating nonhospitalized adults with acute respiratory syncytial virus (RSV) infection. The researchers want to see if obeldesivir can help participants' symptoms get better faster.

The primary objectives of this study are to evaluate the efficacy of ODV in reducing the duration of symptoms and to evaluate the safety and tolerability of ODV in nonhospitalized adult participants with acute RSV infection.

Primary Outcome Measures: Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15, The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity., Day 1 up to Day 15|Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 29, Up to 29 days|Percentage of Participants Experiencing Laboratory Abnormalities Through Day 29, Up to 29 days|Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation, First dose date up to Day 60
Secondary Outcome Measures: Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15, The RiiQ symptom scale is a 13-item questionnaire rated on a 4-point scale. Each symptom is rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity., Day 1 up to Day 15|Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29, RSV-related LRTI will be defined by symptoms (eg, cough, shortness of breath, wheezing, expectoration \[coughing up mucus\]) as assessed by the RiiQ symptom scale., Day 1 up to Day 29|Time to RSV-Related Hospitalization or all-Cause Death Through Day 29, RSV-related hospitalization is defined as ≥ 24 hours of acute care for a reason related to RSV, in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with RSV., Day 1 up to Day 29|Time to RSV-Related Medically Attended Visit (MAVs) or all-Cause Death Through Day 29, Day 1 up to Day 29|Change from baseline in RSV Viral Load Through Day 3, Baseline, Day 3|Change from Baseline in RSV Viral Load Through Day 5, Baseline, Day 5|Change from Baseline in RSV Viral Load Through Day 7, Baseline, Day 7|Change from Baseline in RSV Viral Load Through Day 10, Baseline, Day 10|Change from Baseline in RSV Viral Load Through Day 15, Baseline, Day 15|Pharmacokinetic (PK) Parameter: AUCtau of GS-441524, AUCtau is defined as the area under the concentration versus time curve over the dosing interval., Day 1 to Day 5|PK Parameter: Ctrough of GS-441524, Ctrough is defined as the concentration at the end of the dosing interval, Day 1 to Day 5|PK Parameter: Cmax of GS-441524, Cmax is defined as the maximum observed concentration of drug in plasma., Day 1 to Day 5