Respiratory Syncytial Virus InfectionsPhase 2NCT03379675
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
A Phase 2 study testing JNJ-53718678 500 mg and JNJ-53718678 80 mg in people with Respiratory Syncytial Virus Infections, run by Janssen Research & Development, LLC at 124 sites in 19 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- JNJ-53718678 500 mg and JNJ-53718678 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 124 sitesin 19 countries
- Study dates
- 6 Feb 2018to 26 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
124 sites in 19 countries.
124 sites in 19 countries
United States13 sites
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Core Healthcare Group
Cerritos, California, 90703
Onsite Clinical Solutions
Charlotte, North Carolina, 28277
eStudySite
Chula Vista, California, 919111
Lake Internal Medicine Associates
Eustis, Florida, 32726
Spectrum Medical Research
Gaffney, South Carolina, 29341
SC Clinical Research Inc
Garden Grove, California, 92844
Unity Clinical Research
Lindsay, Oklahoma, 73052
Florida Research Center Inc.
Miami, Florida, 33174
AllinaHealth - Abbott Northwestern Hospital (13520)
Minneapolis, Minnesota, 55407
Family Medicine
Nampa, Idaho, 83686
William Beaumont Hospital
Royal Oak, Michigan, 48073
Fusion Clinical Research of Spartanburg
Spartanburg, South Carolina, 29301
Argentina12 sites
Hospital Espanol De Bahia Blanca
Bahía Blanca, 8000
Hospital Interzonal General de Agudos Dr. Jose Penna
Bahía Blanca, B8001DDU
Hospital Privado - Centro Medico de Cordoba
Barrio Parque Velez Sarfield, X5016KEH
Fundación Respirar
CABA, C1426ABP
Hospital Italiano de La Plata
Ciudad de La Plata, B1900AX
HIGA Prof. Dr. Ramón Carrillo
Ciudadela, 1702
Hospital Rawson
Córdoba, 5000
Hospital Italiano de Cordoba
Córdoba, X5004BAL
Hospital Cordoba
Córdoba, X5004CDT
Sanatorio Juan XXIII
General Roca, 8332
Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
Rosario, S2000DEJ
Clinica Mayo de UMCB
San Miguel de Tucumán, T4000IHE
Brazil10 sites
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu, 18618-970
Universidade Federal de Santa Catarina
Florianópolis, 88036-800
Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN
Natal, 59025-050
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000
Universidade Federal da Bahia - Hospital Professor Edgard Santos
Salvador, 40110-060
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo, 01308 901
Hospital Alemao Oswaldo Cruz
São Paulo, 01421-000
Hospital Heliopolis
São Paulo, 04231-030
Japan10 sites
Fukui General Clinic
Fukui-shi, 910-0067
Koukan Clinic
Kawasaki, 210-0852
Shinkomonji hospital
Kitakyushu, 800-0057
Musashikoganei Clinic
Koganeishi, 184-0004
Medical Square Kuhonji Clinic
Kumamoto, 862-0976
Rinku General Medical Center
Osaka, 598-8577
Tokyo Shinagawa Hospital
Shinagawa-ku, 140-8522
Saino Clinic
Tokorozawa-shi, 359-1141
Toyota Kosei Hospital
Toyota, 470-0396
Shin Yukuhashi Hospital
Yukuhashi, 824-0026
Ukraine8 sites
Medical Center of LL Company 'Scientific Medical Center-Your Doctor'
Kharkiv, 61103
Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
Kharkiv, 61106
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kherson, 73000
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv, 03049
Policlinic of State Joint Stock Holding Company 'Artem'
Kyiv, 04050
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001
Medical Center Ltd 'Health Clinic', Department Of General Therapy
Vinnytsia, 21009
Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University
Vinnytsia, 21021
South Korea7 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si, 14584
Kyungpook National University Hospital
Daegu, 41944
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247
Gachon University Gil Hospital
Incheon, 21565
Inha University Hospital
Incheon, 22322
Kangnam Sacred Heart Hospital
Seoul, 07441
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 7061
Australia6 sites
Paratus Clinical Blacktown Clinic
Blacktown, 2060
Barwon Health - University Hospital Geelong
Geelong, 3220
Paratus Clinical Kanwal Clinic
Kanwal, 2059
Paratus Clinical Kippa Ring Clinic
Kippa-Ring, 4021
Mater Hospital Brisbane
South Brisbane, 4101
Westmead Hospital
Sydney, 2145
Bulgaria6 sites
MHAT 'Sv. Ivan Rilski' Kozloduy EOOD
Kozloduy, 3320
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
Pernik, 2000
SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
Rousse, 7002
MHAT 'Dr. Bratan Shukerov'
Smolyan, 4703
Diagnostic Consultation Centre 'Alexandrovska' EOOD
Sofia, 1431
Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
Troyan Municipality, 5600
France6 sites
Centre Hospitalier d'Agen
Agen, 47923
Cabinet du Dr Remaud
Angers, 49000
Maison Medicale Rive Sud
Mûrs-Erigné, 49610
CHU Nantes - Hotel Dieu
Nantes, 44093
Cabinet du Dr Boye
Nantes, 44300
Cabinet du Dr Baranes
Paris, 75020
Poland6 sites
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis
Kielce, 25-751
Centrum Medyczne All Med
Krakow, 30 033
Diamond Clinic
Krakow, 31 559
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni
Lodz, 90-141
Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna
Ostrów Wielkopolski, 63-400
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
Wroclaw, 51-162
Spain6 sites
Hosp. Gral. Univ. de Alicante
Alicante, 3010
Hosp. Gral. Univ. de Elche
Elche, 3203
Hosp. Univ. Virgen de Las Nieves
Granada, 18014
Hosp. Univ. de La Princesa
Madrid, 28006
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
Hosp. Alvaro Cunqueiro
Vigo, 36213
Mexico5 sites
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230
Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
Guadalajara, 44130
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
RM Pharma Specialists
México, 03100
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
Monterrey, 64460
Russia5 sites
Krasnogorsk city hospital #1
Krasnogorsk, 143408
City Polyclinic #25 of the Nevsky District of SPB
Saint Petersburg, 193312
LLC 'Medical centr 'Reavita Med Spb'
Saint Petersburg, 194354
Eco-safety Ltd
Saint Petersburg, 196143
Research Institute of Influenza
Saint Petersburg, 197376
Taiwan5 sites
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Taipei Medical University Shuang Ho Hospital
New Taipei City, 23561
Kuang Tien General Hospital- Dajia
Taichung, 437
Taipei Municipal Wanfang Hospital
Taipei, 11696
Far Eastern Memorial Hospital
Taipei, 220
Belgium4 sites
CHU Saint-Pierre
Brussels, 1000
Jaak Mortelmans
Ham, 3945
BVBA Dr. Luc Capiau
Massemen, 9230
Testumed
Tessenderlo, 3980
Canada4 sites
Aggarwal and associates Ltd
Brampton, Ontario, L6T 0G1
Milestone Research
London, Ontario, N5W 6A2
Clinique Force Medic (GCP Trials)
Montreal, Quebec, H1M 1B1
Dr Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
Germany4 sites
MECS GmbH
Berlin, 12203
IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
Frankfurt, 60596
Klinische Forschung Hannover-Mitte GmbH
Hanover, 30159
Hausarztpraxis am Lindenplatz
Lübeck, 23554
South Africa4 sites
Soweto Clinical Trial Centre
Johannesburg, 1818
Newtown Clinical Research
Johannesburg, 2001
Emmed Research
Pretoria, 0002
Welkom Clinical Trial Centre
Welkom, 9460
Sweden3 sites
Skanes universitetssjukhus
Malmö, 20502
Norrlands Universitetssjukhus
Umeå, 90185
Akademiska Sjukhuset
Uppsala, 75185
About this study
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
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.
Read the 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- JNJ-53718678 500 mg, JNJ-53718678 80 mg, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-53718678 500 mgDrug
Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
JNJ-53718678 80 mgDrug
Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
PlaceboDrug
In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Experimental | Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days. Receives: Drug: JNJ-53718678 500 mg |
| Treatment B: JNJ-53718678 80 mg + Placebo | Experimental | Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. Receives: Drug: JNJ-53718678 80 mg; Drug: Placebo |
| Treatment C: Placebo | Placebo comparator | Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Measured: Baseline through Day 3
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measured: Baseline through Day 5
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measured: Baseline through Day 8
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Measured: Baseline through Day 14
Change From Baseline in RSV Viral Load at Day 3
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline to Day 3
Change From Baseline in RSV Viral Load at Day 5
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline to Day 5
Change From Baseline in RSV Viral Load at Day 8
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline to Day 8
Change From Baseline in RSV Viral Load at Day 14
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline to Day 14
Change From Baseline in RSV Viral Load at Day 21
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline to Day 21
RSV Viral Load at Baseline
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Baseline
RSV Viral Load at Day 3
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Day 3
RSV Viral Load at Day 5
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Day 5
RSV Viral Load at Day 8
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Day 8
RSV Viral Load at Day 14
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Day 14
RSV Viral Load at Day 21
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Measured: Day 21
Time to Undetectable RSV Viral Load
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Measured: Up to Day 21
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Measured: Day 3
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Measured: Day 5
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Measured: Day 8
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Measured: Day 14
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
Measured: Day 21
Secondary outcomes (19)
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Day 28
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).
Measured: Up to Day 28
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure [SBP] and diastolic blood pressure [DBP]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - < 100 mmHg, Grade 2 (moderate)- greater than or equal to (>=)100 mmHg to < 110 mmHg, Grade 3 (severe)- >=110 mmHg; DBP: Abnormally low- <=90 mmHg, Grade 1 (mild)- 140 mmHg - < 160 mmHg, Grade 2 (moderate)- >=160 mmHg to < 180 mmHg, Grade 3 (severe)- >=180 mmHg.
Measured: Up to Day 28
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]).
Measured: Up to Day 28
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Peripheral capillary oxygen saturation was measured by the investigator over time.
Measured: Baseline, Days 3, 8, 14, and 21
Change From Baseline in Peripheral Capillary Oxygen Saturation
Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.
Measured: Baseline to Days 3, 8, 14 and 21
Pulse Rate Over Time
Pulse rate was measured by the investigator over time.
Measured: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Pulse Rate
Change from baseline in pulse rate was calculated and reported by the investigator.
Measured: Baseline to Days 3, 8, 14 and 21
Respiratory Rate Over Time
Respiratory rate was measured by the investigator over time.
Measured: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Respiratory Rate
Change from baseline in respiratory rate was calculated and reported by the investigator.
Measured: Baseline to Days 3, 8, 14 and 21
Body Temperature Over Time
Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Measured: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Body Temperature
Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.
Measured: Baseline to Days 3, 5, 8, 14 and 21
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.
Measured: 0 to 24 hours post dose on Days 1 and 7
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.
Measured: Baseline, Days 3, 5, 8, 14 and 21
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Measured: Baseline up to Day 21
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).
Measured: Up to Day 21
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.
Measured: Up to Day 21
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.
Measured: Predose on Days 1 and 7
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.
Measured: Days 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start6 Feb 2018
- Primary completion27 Nov 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379675
- Sponsor's protocol ID
- CR108419
- Other IDs
- 2017-003252-24, 53718678RSV2004, 2017
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2017
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nilsson AC, Pullman J, Napora P, Luz K, Gupta A, Draghi J, Guzman Romero AK, Aggarwal N, Petrova G, Ianus J, Vijgen L, Scott J, Sinha R, Rusch S, Huntjens D, Bertzos K, Stevens M; ROSE Study Group. A pilot phase 2a, randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir at two dose levels in non-hospitalized adults with respiratory syncytial virus infection. Clin Microbiol Infect. 2023 Oct;29(10):1320-1327. doi: 10.1016/j.cmi.2023.07.004. Epub 2023 Jul 6.
PubMed 37422079
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03379675
- Acronym / sponsor ID
- CR108419
- Conditions
- Respiratory Syncytial Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: JNJ-53718678 500 mg | Experimental | Drug: JNJ-53718678 500 mgParticipants will receive 500 mg dose of JNJ-53718678 once daily for 7 days. |
| Treatment B: JNJ-53718678 80 mg + Placebo | Experimental | Drug: JNJ-53718678 80 mg, Drug: PlaceboParticipants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. |
| Treatment C: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-53718678 500 mgParticipants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days. | Drug | Treatment A: JNJ-53718678 500 mg |
| JNJ-53718678 80 mgParticipants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. | Drug | Treatment B: JNJ-53718678 80 mg + Placebo |
| PlaceboIn treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days. | Drug | Treatment B: JNJ-53718678 80 mg + Placebo, Treatment C: Placebo |
Primary outcome
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
Time frame: Baseline through Day 3
Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5
Time frame: Baseline through Day 5
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8
Time frame: Baseline through Day 8
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14
Time frame: Baseline through Day 14
Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.
Change From Baseline in RSV Viral Load at Day 3
Time frame: Baseline to Day 3
Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 5
Time frame: Baseline to Day 5
Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 8
Time frame: Baseline to Day 8
Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 14
Time frame: Baseline to Day 14
Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Change From Baseline in RSV Viral Load at Day 21
Time frame: Baseline to Day 21
Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Baseline
Time frame: Baseline
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 3
Time frame: Day 3
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 5
Time frame: Day 5
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 8
Time frame: Day 8
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 14
Time frame: Day 14
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
RSV Viral Load at Day 21
Time frame: Day 21
RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.
Time to Undetectable RSV Viral Load
Time frame: Up to Day 21
The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.
Percentage of Participants With Undetectable RSV Viral Load at Day 3
Time frame: Day 3
Percentage of participants with undetectable RSV viral load at Day 3 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 5
Time frame: Day 5
Percentage of participants with undetectable RSV viral load at Day 5 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 8
Time frame: Day 8
Percentage of participants with undetectable RSV viral load at Day 8 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 14
Time frame: Day 14
Percentage of participants with undetectable RSV viral load at Day 14 were reported.
Percentage of Participants With Undetectable RSV Viral Load at Day 21
Time frame: Day 21
Percentage of participants with undetectable RSV viral load at Day 21 were reported.
19 secondary outcomes
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to Day 28
Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities
Time frame: Up to Day 28
Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities
Time frame: Up to Day 28
Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities
Time frame: Up to Day 28
Peripheral Capillary Oxygen Saturation (SpO2) Over Time
Time frame: Baseline, Days 3, 8, 14, and 21
Change From Baseline in Peripheral Capillary Oxygen Saturation
Time frame: Baseline to Days 3, 8, 14 and 21
Pulse Rate Over Time
Time frame: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Pulse Rate
Time frame: Baseline to Days 3, 8, 14 and 21
Respiratory Rate Over Time
Time frame: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Respiratory Rate
Time frame: Baseline to Days 3, 8, 14 and 21
Body Temperature Over Time
Time frame: Baseline, Days 3, 8, 14 and 21
Change From Baseline in Body Temperature
Time frame: Baseline to Days 3, 5, 8, 14 and 21
Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose
Time frame: 0 to 24 hours post dose on Days 1 and 7
Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire
Time frame: Baseline, Days 3, 5, 8, 14 and 21
Duration of Signs and Symptoms of RSV Assessed by RI-PRO
Time frame: Baseline up to Day 21
Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire
Time frame: Up to Day 21
Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire
Time frame: Up to Day 21
Predose Plasma Concentration (Ctrough) of JNJ-53718678
Time frame: Predose on Days 1 and 7
Maximum Plasma Concentration (Cmax) of JNJ-53718678
Time frame: Days 1 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37422079Nilsson AC, Pullman J, Napora P, Luz K, Gupta A, Draghi J, Guzman Romero AK, Aggarwal N, Petrova G, Ianus J, Vijgen L, Scott J, Sinha R, Rusch S, Huntjens D, Bertzos K, Stevens M; ROSE Study Group. A pilot phase 2a, randomized, double-blind, placebo-controlled study to explore the antiviral activity, clinical outcomes, safety, and tolerability of rilematovir at two dose levels in non-hospitalized adults with respiratory syncytial virus infection. Clin Microbiol Infect. 2023 Oct;29(10):1320-1327. doi: 10.1016/j.cmi.2023.07.004. Epub 2023 Jul 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
124 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-53718678 500 mg and JNJ-53718678 80 mg in people with Respiratory Syncytial Virus Infections, run by Janssen Research & Development, LLC at 124 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 124 sites in United States, Argentina, Brazil, Japan, Ukraine and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline through Day 3). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03379675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.