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STATUS Recruiting

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

See if you qualify OR Call 1-833-GIL-EAD-6
See if you qualify OR Call 1-833-GIL-EAD-6

LAST UPDATED

October 21 2024

Clinicaltrials.gov ID

NCT06585150

OVERVIEW

A Phase 2 Randomized, Placebo-controlled Study of the Safety and Efficacy of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

PROTOCOL 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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

RSV Infection

Gender

N/A

Date

October 2024 - September 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Obeldesivir, Obeldesivir Placebo

Eligibility Information

Inclusion

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.
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Exclusion

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.
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Locations

Locations (44)
Recruiting

Central Alabama Research

Birmingham, Alabama, United States, 35209

Recruiting

Epic Medical Research-Surprise

Surprise, Arizona, United States, 85378

Recruiting

L.A. Universal Research Center, INC.

Los Angeles, California, United States, 90057

Recruiting

Paradigm Clinical Research

Redding, California, United States, 96001

Recruiting

Paradigm Clinical Research Centers, LLC., Wheat Ridge

Wheat Ridge, Colorado, United States, 80033

Recruiting

Prestige Clinical Research Center Inc

Coral Gables, Florida, United States, 33134

Recruiting

Proactive Clinical Research, LLC

Fort Lauderdale, Florida, United States, 33308

Recruiting

Evolution Clinical Trials

Hialeah Gardens, Florida, United States, 33016

Recruiting

Indago Research & Health Center, Inc.

Hialeah, Florida, United States, 33012

Recruiting

Research In Miami, Inc.

Hialeah, Florida, United States, 33013

Recruiting

Doral Medical Research, LLC

Hialeah, Florida, United States, 33016

Recruiting

Sync, LLC

Hialeah, Florida, United States, 33016

Recruiting

Health Awareness, LLC

Jupiter, Florida, United States, 33458

Recruiting

Clinical Site Partners LLC dba Flourish Research

Leesburg, Florida, United States, 34748

Recruiting

Pro-Care Research Center

Miami Gardens, Florida, United States, 33014

Recruiting

Essential Clinical Research, Inc

Miami Lakes, Florida, United States, 33014

Recruiting

LCC Medical Research Institute

Miami, Florida, United States, 33126

Recruiting

CCM Clinical Research Group, LLC.

Miami, Florida, United States, 33133

Recruiting

Retreat Medical Research

Miami, Florida, United States, 33135

Recruiting

Clinical Trial Services, Corp

Miami, Florida, United States, 33144

Recruiting

Continental Clinical Research, LLC

Miami, Florida, United States, 33144

Recruiting

Dynamic Medical Research, LLC - Miami

Miami, Florida, United States, 33144

Recruiting

Nuren Medical & Research Center

Miami, Florida, United States, 33144

Recruiting

Cordova Research Institute

Miami, Florida, United States, 33155

Recruiting

Miami Clinical Research

Miami, Florida, United States, 33155

Recruiting

P&S Research, LLC.

Miami, Florida, United States, 33175

Recruiting

Pro Live Medical Research

Miami, Florida, United States, 33175

Recruiting

Links Clinical Trials LLC

Miami, Florida, United States, 33176

Recruiting

Reed Medical Research

Miami, Florida, United States, 33176

Recruiting

Oceanic Research Group

North Miami Beach, Florida, United States, 33169

Recruiting

USPA Advance Concept Medical Research Group. LLC

South Miami, Florida, United States, 33143

Recruiting

Precision Research Center Inc

Tampa, Florida, United States, 33614

Recruiting

Paradigm Clinical Research

Boise, Idaho, United States, 83709

Recruiting

Tranquil Clinical Research

Webster, Iowa, United States, 77598

Recruiting

Be Well Clinical Studies

Lincoln, Nebraska, United States, 78681

Recruiting

Clinical Research of South Nevada

Las Vegas, Nevada, United States, 89121

Recruiting

Prime Global Research, Inc.

New York, New York, United States, 10456

Recruiting

Monroe Biomedical Research

Monroe, North Carolina, United States, 28112

Recruiting

Central Texas Clinical Research

Austin, Texas, United States, 78705

Recruiting

Inquest Clinical Research

Baytown, Texas, United States, 77521

Recruiting

PanAmerican Clinical Research, LLC

Brownsville, Texas, United States, 78520

Recruiting

Next Level Urgent Care

Houston, Texas, United States, 77095

Recruiting

Andres Garcia-Zuniga, MD, PA

Laredo, Texas, United States, 78041

Recruiting

Epic Medical Research LLC - DeSoto

Red Oak, Texas, United States, 75154