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Anti-viral

Obeldesivir for RSV Infection

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

RSV vaccine status: Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV

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

Must not have

Individuals with a history of cystic fibrosis

Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to day 29

Summary

"This trial aims to study a drug called obeldesivir (ODV; GS-5245) to see how safe and effective it is in treating nonhospitalized adults with acute respiratory sync

Who is the study for?

Adults over 60, or those with moderate/severe COPD, asthma, bronchiectasis, interstitial lung disease (like pulmonary fibrosis), pulmonary hypertension, or chronic heart disease can join. They must have confirmed RSV infection within the past 3 days and show new or worsening symptoms of at least moderate severity.

What is being tested?

The trial is testing Obeldesivir's effectiveness in reducing symptom duration for nonhospitalized adults with acute RSV. Participants will either receive Obeldesivir or a placebo to compare outcomes.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to determine the safety and tolerability of Obeldesivir.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 60 and have not received an RSV vaccine.

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I have recently developed or worsened symptoms of an RSV infection.

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I am over 60 or have COPD, asthma, chronic lung disease, or chronic heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cystic fibrosis.

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I have not taken antibiotics or antifungal medications in the last 7 days.

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I might need to be hospitalized soon after joining the study.

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I was hospitalized or had an infection due to RSV this season.

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I haven't taken any experimental drugs within the last 28 days or 5 half-lives.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

PK Parameter: Cmax of GS-441524

PK Parameter: Ctrough of GS-441524

Pharmacokinetic (PK) Parameter: AUCtau of GS-441524

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