A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Respiratory Syncytial Virus
In brief
The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
Key facts
- Study ID
- NCT04978337
- Run by
- Janssen Research & Development, LLC
- People needed
- 5
- Starts
- 2021-11-17
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2024-09-24
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection
- Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms pre-existed
- Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample
- Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
- Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms
- Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than [<] 24 hours are not considered as hospitalization)
You may not qualify if…
- Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation
- Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia
- Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection
- Immunocompromised conditions
- Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
Where it is running
- Fiel Family and Sports Medicine Clinical Research Advantage — Tempe, Arizona, United States
- IMD Clinical Trials — Bakersfield, California, United States
- Hope clinical Research LLC — Canoga Park, California, United States
- Peninsula Research Associates — Rolling Hills Estates, California, United States
- Bensch Clinical Research, LLC — Stockton, California, United States
- New Life Medical Research Center, Inc. — Hialeah, Florida, United States
- Best Quality Research Inc — Hialeah, Florida, United States
- Homestead Associates in Research, Inc — Homestead, Florida, United States
- Care Partners Clinical Research — Jacksonville, Florida, United States
- Research Institute Of South Florida, Inc. — Miami, Florida, United States
- Pines Care Research Center Inc — Pembroke Pines, Florida, United States
- Santos Research Center — Tampa, Florida, United States
- Privia Medical Group, LLC — Fayetteville, Georgia, United States
- Southcoast Health — Savannah, Georgia, United States
- North Georgia Clinical Research — Woodstock, Georgia, United States
- Chesapeake Clinical Research, Inc. — White Marsh, Maryland, United States
- Montana Medical Research — Missoula, Montana, United States
- Excel Clinical Research — Las Vegas, Nevada, United States
- Burke Primary Care — Morganton, North Carolina, United States
- Dayton Clinical Research — Dayton, Ohio, United States
- Pulmonologist, Critical Care, and Sleep Medicine — Wyomissing, Pennsylvania, United States
- Piedmont Clinical Research — Fort Mill, South Carolina, United States
- Texas Health Care, PLLC — Fort Worth, Texas, United States
- Mercury Clinical Research — Houston, Texas, United States
- Central Alabama Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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