A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infections

In brief

The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams \[mg\] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.

Key facts

Study ID

NCT03379675

Run by

Janssen Research & Development, LLC

People needed

72

Starts

2018-02-06

Expected to finish

2019-12-26

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to 5 days from the anticipated time of randomization. Onset of symptoms is defined as the time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
• Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
• Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile
• A male participant must agree to the use of acceptable contraceptive measures
• With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening

You may not qualify if…

• Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
• History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
• Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
• Participants who are considered by the investigator to be immunocompromised within the past 12 months
• Participant has known or suspected chronic or acute hepatitis B or C infection
• Women who are pregnant or breastfeeding
• Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator

Where it is running

• eStudySite — Chula Vista, California, United States
• SC Clinical Research Inc — Garden Grove, California, United States
• Lake Internal Medicine Associates — Eustis, Florida, United States
• Florida Research Center Inc. — Miami, Florida, United States
• Family Medicine — Nampa, Idaho, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• AllinaHealth - Abbott Northwestern Hospital (13520) — Minneapolis, Minnesota, United States
• Mercury Street Medical Group, PLLC — Butte, Montana, United States
• Onsite Clinical Solutions — Charlotte, North Carolina, United States
• Unity Clinical Research — Lindsay, Oklahoma, United States
• Spectrum Medical Research — Gaffney, South Carolina, United States
• Fusion Clinical Research of Spartanburg — Spartanburg, South Carolina, United States
• Hospital Espanol De Bahia Blanca — Bahía Blanca, Argentina
• Hospital Interzonal General de Agudos Dr. Jose Penna — Bahía Blanca, Argentina
• Hospital Privado - Centro Medico de Cordoba — Barrio Parque Velez Sarfield, Argentina
• Fundación Respirar — CABA, Argentina
• Hospital Italiano de La Plata — Ciudad de La Plata, Argentina
• HIGA Prof. Dr. Ramón Carrillo — Ciudadela, Argentina
• Hospital Rawson — Córdoba, Argentina
• Hospital Italiano de Cordoba — Córdoba, Argentina
• Hospital Cordoba — Córdoba, Argentina
• Sanatorio Juan XXIII — General Roca, Argentina
• Instituto Médico de la Fundación de Estudios Clínicos (ECLIN) — Rosario, Argentina
• Clinica Mayo de UMCB — San Miguel de Tucumán, Argentina
• Core Healthcare Group — Cerritos, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.