Clinical trial NCT03379675: 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
Official title: A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-12-20
Enrollment: 72
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 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.

Detailed description: This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3
timeFrame: Baseline through Day 3
measure: Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
timeFrame: Baseline through Day 5
measure: Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
timeFrame: Baseline through Day 8
measure: Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
timeFrame: Baseline through Day 14
measure: Change From Baseline in RSV Viral Load at Day 3
timeFrame: Baseline to Day 3
measure: Change From Baseline in RSV Viral Load at Day 5
timeFrame: Baseline to Day 5
measure: Change From Baseline in RSV Viral Load at Day 8
timeFrame: Baseline to Day 8
measure: Change From Baseline in RSV Viral Load at Day 14
timeFrame: Baseline to Day 14
measure: Change From Baseline in RSV Viral Load at Day 21
timeFrame: Baseline to Day 21
measure: RSV Viral Load at Baseline
timeFrame: Baseline
measure: RSV Viral Load at Day 3
timeFrame: Day 3
measure: RSV Viral Load at Day 5
timeFrame: Day 5
measure: RSV Viral Load at Day 8
timeFrame: Day 8
measure: RSV Viral Load at Day 14
timeFrame: Day 14
measure: RSV Viral Load at Day 21
timeFrame: Day 21
measure: Time to Undetectable RSV Viral Load
timeFrame: Up to Day 21
measure: Percentage of Participants With Undetectable RSV Viral Load at Day 3
timeFrame: Day 3
measure: Percentage of Participants With Undetectable RSV Viral Load at Day 5
timeFrame: Day 5
measure: Percentage of Participants With Undetectable RSV Viral Load at Day 8
timeFrame: Day 8
measure: Percentage of Participants With Undetectable RSV Viral Load at Day 14
timeFrame: Day 14
measure: Percentage of Participants With Undetectable RSV Viral Load at Day 21
timeFrame: Day 21
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to Day 28
measure: Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
timeFrame: Up to Day 28
measure: Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
timeFrame: Up to Day 28
measure: Peripheral Capillary Oxygen Saturation (SpO2) Over Time
timeFrame: Baseline, Days 3, 8, 14, and 21
measure: Change From Baseline in Peripheral Capillary Oxygen Saturation
timeFrame: Baseline to Days 3, 8, 14 and 21
measure: Pulse Rate Over Time
timeFrame: Baseline, Days 3, 8, 14 and 21
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline to Days 3, 8, 14 and 21
measure: Respiratory Rate Over Time
timeFrame: Baseline, Days 3, 8, 14 and 21
measure: Change From Baseline in Respiratory Rate
timeFrame: Baseline to Days 3, 8, 14 and 21
measure: Body Temperature Over Time
timeFrame: Baseline, Days 3, 8, 14 and 21
measure: Change From Baseline in Body Temperature
timeFrame: Baseline to Days 3, 5, 8, 14 and 21
measure: Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
timeFrame: 0 to 24 hours post dose on Days 1 and 7
measure: Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
timeFrame: Baseline, Days 3, 5, 8, 14 and 21
measure: Duration of Signs and Symptoms of RSV Assessed by RI-PRO
timeFrame: Baseline up to Day 21
measure: Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
timeFrame: Up to Day 21
measure: Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
timeFrame: Up to Day 21
measure: Predose Plasma Concentration (Ctrough) of JNJ-53718678
timeFrame: Predose on Days 1 and 7
measure: Maximum Plasma Concentration (Cmax) of JNJ-53718678
timeFrame: Days 1 and 7
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research Inc
state: California
city: Eustis
country: United States
facility: Lake Internal Medicine Associates
state: Florida
city: Miami
country: United States
facility: Florida Research Center Inc.
state: Florida
city: Nampa
country: United States
facility: Family Medicine
state: Idaho
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: AllinaHealth - Abbott Northwestern Hospital (13520)
state: Minnesota
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Charlotte
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Lindsay
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Gaffney
country: United States
facility: Spectrum Medical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Fusion Clinical Research of Spartanburg
state: South Carolina
city: Bahia Blanca
country: Argentina
facility: Hospital Espanol De Bahia Blanca
city: Bahia Blanca
country: Argentina
facility: Hospital Interzonal General de Agudos Dr. Jose Penna
city: Barrio Parque Velez Sarfield
country: Argentina
facility: Hospital Privado - Centro Medico de Cordoba
city: Caba
country: Argentina
facility: Fundación Respirar
city: Ciudad De La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Ciudadela
country: Argentina
facility: HIGA Prof. Dr. Ramón Carrillo
city: Cordoba
country: Argentina
facility: Hospital Rawson
city: Cordoba
country: Argentina
facility: Hospital Italiano de Cordoba
city: Cordoba
country: Argentina
facility: Hospital Cordoba
city: General Roca
country: Argentina
facility: Sanatorio Juan XXIII
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo de UMCB
city: Blacktown
country: Australia
facility: Paratus Clinical Blacktown Clinic
city: Geelong
country: Australia
facility: Barwon Health - University Hospital Geelong
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal Clinic
city: Kippa Ring
country: Australia
facility: Paratus Clinical Kippa Ring Clinic
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
city: Sydney
country: Australia
facility: Westmead Hospital
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
city: Ham
country: Belgium
facility: Jaak Mortelmans
city: Massemen
country: Belgium
facility: BVBA Dr. Luc Capiau
city: Tessenderlo
country: Belgium
facility: Testumed
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Botucatu
country: Brazil
facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
city: Florianopolis
country: Brazil
facility: Universidade Federal de Santa Catarina
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
city: Passo Fundo
country: Brazil
facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia - Hospital Professor Edgard Santos
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz
city: Sao Paulo
country: Brazil
facility: Hospital Heliopolis
city: São Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
city: Kozloduy
country: Bulgaria
facility: MHAT 'Sv. Ivan Rilski' Kozloduy EOOD
city: Pernik
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
city: Ruse
country: Bulgaria
facility: SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
city: Smolyan
country: Bulgaria
facility: MHAT 'Dr. Bratan Shukerov'
city: Sofia
country: Bulgaria
facility: Diagnostic Consultation Centre 'Alexandrovska' EOOD
city: Troyan
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
city: Brampton
country: Canada
facility: Aggarwal and associates Ltd
state: Ontario
city: London
country: Canada
facility: Milestone Research
state: Ontario
city: Toronto
country: Canada
facility: Dr Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Montreal
country: Canada
facility: Clinique Force Medic (GCP Trials)
state: Quebec
city: Agen cedex 9
country: France
facility: Centre Hospitalier d'Agen
city: Angers
country: France
facility: Cabinet du Dr Remaud
city: Murs Erigne
country: France
facility: Maison Medicale Rive Sud
city: Nantes
country: France
facility: CHU Nantes - Hotel Dieu
city: Nantes
country: France
facility: Cabinet du Dr Boye
city: Paris
country: France
facility: Cabinet du Dr Baranes
city: Berlin
country: Germany
facility: MECS GmbH
city: Frankfurt
country: Germany
facility: IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Luebeck
country: Germany
facility: Hausarztpraxis am Lindenplatz
city: Fukui-shi
country: Japan
facility: Fukui General Clinic
city: Kawasaki
country: Japan
facility: Koukan Clinic
city: Kitakyusyu
country: Japan
facility: Shinkomonji hospital
city: Koganei-Shi
country: Japan
facility: Musashikoganei Clinic
city: Kumamoto-shi
country: Japan
facility: Medical Square Kuhonji Clinic
city: Osaka
country: Japan
facility: Rinku General Medical Center
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital
city: Tokorozawa-shi
country: Japan
facility: Saino Clinic
city: Toyota
country: Japan
facility: Toyota Kosei Hospital
city: Yukuhashi
country: Japan
facility: Shin Yukuhashi Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic university of Korea, St. Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
city: Mexico
country: Mexico
facility: RM Pharma Specialists
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
city: Kielce
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis
city: Krakow
country: Poland
facility: Centrum Medyczne All Med
city: Krakow
country: Poland
facility: Diamond Clinic
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni
city: Ostrow Wielkopolski
country: Poland
facility: Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
city: Krasnogorsk
country: Russian Federation
facility: Krasnogorsk city hospital #1
city: Saint-Petersburg
country: Russian Federation
facility: City Polyclinic #25 of the Nevsky District of SPB
city: Saint-Petersburg
country: Russian Federation
facility: LLC 'Medical centr 'Reavita Med Spb'
city: Saint-Petersburg
country: Russian Federation
facility: Eco-safety Ltd
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Influenza
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trial Centre
city: Johannesburg
country: South Africa
facility: Newtown Clinical Research
city: Pretoria
country: South Africa
facility: Emmed Research
city: Welkom
country: South Africa
facility: Welkom Clinical Trial Centre
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Elche
country: Spain
facility: Hosp. Gral. Univ. de Elche
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hosp. Univ. de La Princesa
city: Santiago de Compostela
country: Spain
facility: Hosp. Clinico Univ. de Santiago
city: Vigo
country: Spain
facility: Hosp. Alvaro Cunqueiro
city: Malmö
country: Sweden
facility: Skanes universitetssjukhus
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung City
country: Taiwan
facility: Kuang Tien General Hospital- Dajia
city: Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Kharkiv
country: Ukraine
facility: Medical Center of LL Company 'Scientific Medical Center-Your Doctor'
city: Kharkiv
country: Ukraine
facility: Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
city: Kherson
country: Ukraine
facility: Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
city: Kyiv
country: Ukraine
facility: Policlinic of State Joint Stock Holding Company 'Artem'
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsya
country: Ukraine
facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy
city: Vinnytsya
country: Ukraine
facility: Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: