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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Exhibits at least 1 of the following risk factors for severe RSV disease: 1. Age ≥ 60 years 2. Moderate or severe chronic obstructive pulmonary disease (COPD) 3. Asthma 4. One or more of the following chronic lung diseases: - i) Bronchiectasis - ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis) - iii) Pulmonary hypertension 5. Chronic cardiovascular disease exclusive of hypertension - RSV infection confirmed ≤ 3 days before randomization - Acute RSV infection defined as RSV infection plus new onset or increased from baseline of symptoms, and at least 1 symptom of moderate severity within 3 days prior to randomization. - RSV vaccine status: - Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.

Exclusion Criteria

  • 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Obeldesivir (ODV) 		Participants will receive obeldesivir for 5 days
  • Drug: Obeldesivir
    Tablet administered orally
    Other names:
    • GS-5245
Experimental
Placebo comparator: Obeldesivir Placebo 		Participants will receive obeldesivir placebo for 5 days
  • Drug: Obeldesivir Placebo
    Tablet administered orally

Recruiting Locations

Georgetown University Medical Center
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.