Clinical trial NCT06585150: Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: RSV Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-09-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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) with a history of exacerbation during the preceding 12 months.
  3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
  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
* 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 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.

Primary outcomes:
measure: Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms as Measured by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) through Day 15
timeFrame: Day 1 up to Day 15
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 29
timeFrame: Up to 29 days
measure: Percentage of Participants Experiencing Laboratory Abnormalities Through Day 29
timeFrame: Up to 29 days
measure: Percentage of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Study Drug Discontinuation
timeFrame: First dose date up to Day 60
Secondary outcomes:
measure: Time to Sustained Alleviation of Targeted RSV Symptoms as Measured by RiiQ Through Day 15
timeFrame: Day 1 up to Day 15
measure: Time to RSV-Related Lower Respiratory Tract Infection (LRTI) Through Day 29
timeFrame: Day 1 up to Day 29
measure: Time to RSV-Related Hospitalization or all-Cause Death Through Day 29
timeFrame: Day 1 up to Day 29
measure: Time to RSV-Related Medically Attended Visit (MAVs) or all-Cause Death Through Day 29
timeFrame: Day 1 up to Day 29
measure: Change from baseline in RSV Viral Load Through Day 3
timeFrame: Baseline, Day 3
measure: Change from Baseline in RSV Viral Load Through Day 5
timeFrame: Baseline, Day 5
measure: Change from Baseline in RSV Viral Load Through Day 7
timeFrame: Baseline, Day 7
measure: Change from Baseline in RSV Viral Load Through Day 10
timeFrame: Baseline, Day 10
measure: Change from Baseline in RSV Viral Load Through Day 15
timeFrame: Baseline, Day 15
measure: Pharmacokinetic (PK) Parameter: AUCtau of GS-441524
timeFrame: Day 1 to Day 5
measure: PK Parameter: Ctrough of GS-441524
timeFrame: Day 1 to Day 5
measure: PK Parameter: Cmax of GS-441524
timeFrame: Day 1 to Day 5
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research, LLC
state: Alabama
city: Scottsdale
country: United States
facility: Headlands Research-Scottsdale
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research-Surprise
state: Arizona
city: Canyon Country
country: United States
facility: Clearview Medical Research, LLC
state: California
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medica Center
state: California
city: Fresno
country: United States
facility: University of California, San Francisco-Fresno
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center, Inc.
state: California
city: Los Angeles
country: United States
facility: L.A. Universal Research Center, INC.
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Pomona
country: United States
facility: National Institute of Clinical Research, Inc
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research
state: California
city: San Diego
country: United States
facility: M3 Wake Research San Diego
state: California
city: Santa Maria
country: United States
facility: FOMAT Medical Research - Central Coast Family Care
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc.
state: California
city: Aurora
country: United States
facility: Allianz Research Institute- Colorado
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, LLC., Wheat Ridge
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach, LLC
state: Florida
city: Cape Coral
country: United States
facility: C & A Clinical trials Corp
state: Florida
city: Coral Gables
country: United States
facility: Prestige Clinical Research Center Inc
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: Doral
country: United States
facility: UHC Research, LLC
state: Florida
city: Doral
country: United States
facility: Dolphin Medical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research, LLC
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Aga Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Research In Miami, Inc.
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Sync, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, LLC
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - St. Pete-Largo Clinical Research Unit
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners LLC dba Flourish Research
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center
state: Florida
city: Miami Lakes
country: United States
facility: Essential Clinical Research, Inc
state: Florida
city: Miami Lakes
country: United States
facility: Southern Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group, LLC.
state: Florida
city: Miami
country: United States
facility: Retreat Medical Research
state: Florida
city: Miami
country: United States
facility: Clinical Trial Services, Corp
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research, LLC - Miami
state: Florida
city: Miami
country: United States
facility: Nuren Medical & Research Center
state: Florida
city: Miami
country: United States
facility: Advanced Care and Clinical Trials, LLC
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: P&S Research, LLC.
state: Florida
city: Miami
country: United States
facility: Pro Live Medical Research
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Links Clinical Trials LLC
state: Florida
city: Miami
country: United States
facility: Reed Medical Research
state: Florida
city: Miami
country: United States
facility: Nuovida Research Center, Corp
state: Florida
city: North Miami Beach
country: United States
facility: Oceanic Research Group
state: Florida
city: Palm Springs
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: South Miami
country: United States
facility: USPA Advance Concept Medical Research Group. LLC
state: Florida
city: Tampa
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: Precision Research Center Inc
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials, LLC
state: Georgia
city: Boise
country: United States
facility: Paradigm Clinical Research
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Burr Ridge
country: United States
facility: Metro Infectious Disease Consultants
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health - Clinical Trials Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Iowa
city: Versailles
country: United States
facility: CCT Research- Versailles Family Medicine
state: Kentucky
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Mankato
country: United States
facility: Javara Inc.
state: Minnesota
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System, Inc
state: Missouri
city: Kansas City
country: United States
facility: Clay-Platte Family Medicine/Avacare
state: Missouri
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Bronx
country: United States
facility: NYC Health and Hospitals-Lincoln
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: Prime Global Research, Inc.
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Raleigh
country: United States
facility: Eximia Research-NC, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: The Lidner Research Center at The Christ Hospital
state: Ohio
city: Chickasha
country: United States
facility: Epic Medical Research- Oklahoma
state: Oklahoma
city: Anderson
country: United States
facility: Velocity Clinical Research - Anderson
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research, LLC
state: Texas
city: Carrollton
country: United States
facility: Epic Medical Research-Carrollton
state: Texas
city: Dallas
country: United States
facility: WR- Global Medical Research, LLC
state: Texas
city: Houston
country: United States
facility: Vilo Research Group, Inc
state: Texas
city: Houston
country: United States
facility: C & R Research Services USA, Inc.
state: Texas
city: Houston
country: United States
facility: Diversified Medical Practices
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, INC.
state: Texas
city: Keller
country: United States
facility: Helios Clinical Keller
state: Texas
city: Laredo
country: United States
facility: Andres Garcia-Zuniga, MD, PA
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research LLC - DeSoto
state: Texas
city: Sherman
country: United States
facility: Medrasa Clinical Research
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research-Salt Lake City
state: Utah
city: Portsmouth
country: United States
facility: Velocity Clinical Research- Suffolk
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: Swedish Organ transplant and Liver Center
state: Washington
city: Kingwood
country: United States
facility: Frontier Clinical Research. LLC Kingwood
state: West Virginia
city: Morgantown
country: United States
facility: Frontier Clinical Research, LLC
state: West Virginia
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: