TerminatedPhase 2

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

Stopped: Study was terminated by Sponsor; the decision was not due to any safety findings.

United States150 participantsStarted 2024-10-14

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. Chronic cardiovascular disease exclusive of hypertension

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Through Day 15

Timeframe: Up to Day 15

Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Serious Adverse Events

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation

Timeframe: Up to 5 days plus 30 days

Trial details

NCT IDNCT06585150

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-08

Results submitted2026-05-07

View on ClinicalTrials.gov More RSV Infection trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. Chronic cardiovascular disease exclusive of hypertension

What they're measuring

Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Through Day 15

Timeframe: Up to Day 15

Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Treatment-emergent Laboratory Abnormalities

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Serious Adverse Events

Timeframe: Up to 5 days plus 30 days

Percentage of Participants Who Experienced Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation

Timeframe: Up to 5 days plus 30 days