Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
- Registration Number
- NCT06585150
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
-
Exhibits at least 1 of the following risk factors for severe RSV disease:
-
Age ≥ 60 years
-
Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
-
Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
-
One or more of the following chronic lung diseases:
- i) Bronchiectasis
- ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
- iii) Pulmonary hypertension
-
Chronic cardiovascular disease exclusive of hypertension
-
-
RSV infection confirmed ≤ 3 days before randomization
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New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization.
-
RSV vaccine status:
- Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.
Key
- Currently requiring or expected to require hospitalization within 48 hours after randomization.
- Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
- Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
- Individuals with a history of cystic fibrosis.
- Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
- Pregnant at screening.
- Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV < 28 days or < 5 half-lives, whichever is longer, before randomization.
- Received an investigational product < 28 days or < 5 half-lives, whichever is longer, before randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeldesivir (ODV) Obeldesivir Participants will receive obeldesivir for 5 days Placebo comparator: Obeldesivir Placebo Obeldesivir Placebo Participants will receive obeldesivir placebo for 5 days
- Primary Outcome Measures
Name Time Method Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15 Day 1 up to 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.
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
Name Time Method Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15 Day 1 up to 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.
Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29 Day 1 up to 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.
Time to RSV-Related Hospitalization or all-Cause Death Through Day 29 Day 1 up to 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.
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 Day 1 to Day 5 AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
PK Parameter: Ctrough of GS-441524 Day 1 to Day 5 Ctrough is defined as the concentration at the end of the dosing interval
PK Parameter: Cmax of GS-441524 Day 1 to Day 5 Cmax is defined as the maximum observed concentration of drug in plasma.
Trial Locations
- Locations (117)
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
Headlands Research-Scottsdale
🇺🇸Scottsdale, Arizona, United States
Epic Medical Research-Surprise
🇺🇸Surprise, Arizona, United States
Clearview Medical Research, LLC
🇺🇸Canyon Country, California, United States
Kaiser Permanente Fontana Medica Center
🇺🇸Fontana, California, United States
University of California, San Francisco-Fresno
🇺🇸Fresno, California, United States
Downtown L.A. Research Center, Inc.
🇺🇸Los Angeles, California, United States
L.A. Universal Research Center, INC.
🇺🇸Los Angeles, California, United States
Scroll for more (107 remaining)Central Alabama Research🇺🇸Birmingham, Alabama, United States