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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04978337
Other study ID # CR109031
Secondary ID 53718678RSV20082
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 17, 2021
Est. completion date March 31, 2022

Study information

Verified date March 2023
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Rilematovir is an investigational RSV specific fusion inhibitor currently in development for the treatment of RSV infection in both adult and pediatric populations. The study will include a Screening period (Day -1 to Day 1), a Treatment period (Day 1 to Day 7/8 [depending on timing of first dose]), and a Follow-up period (Day 8/9 to Day 35). The total study duration of the study for each participant will be up to 35 days. The study will evaluate efficacy and safety of RSV in adult outpatients (18-85 years) who are at high risk of RSV related disease progression and have at least moderate RSV disease. The efficacy assessments include evaluation with electronic patient-reported outcome (ePRO) and the safety assessments include evaluations of physical examinations, vital signs, electrocardiograms, clinical laboratory tests, and adverse events.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date March 31, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rilematovir
Rilematovir 250 mg will be administered orally.
Placebo
Placebo matching to rilematovir will be administered orally.

Locations

Country Name City State
Argentina INAER - Investigación en Alergias y Enfermedades Respiratorias Ciudad Autónoma de Buenos Aires
Argentina Centro Respiratorio Quilmes Quilmes
Argentina Centro Medico Respire San Fernando
Argentina Clinica Mayo de UMCB San Miguel de Tucuman
Argentina Investigaciones en Patologias Respiratorias San Miguel de Tucumán
Bulgaria Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo Haskovo
Bulgaria Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik Pernik
Bulgaria SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD Ruse
Bulgaria Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD Troyan
Canada Dr. Anil K Gupta Medicine Professional Corporation Toronto Ontario
Germany Universitatsklinikum Bonn Bonn
Germany IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum Frankfurt
Germany Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut Leipzig
Germany Praxis Dr. Weimer Reinfeld
Hungary Strázsahegy Medicina Bt Budapest
Hungary Omnimodus Elixír Kft. Csorna
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli' Roma
Japan Nagata Hospital Fukuoka
Japan Nishifukuoka Hospital Fukuoka
Japan Terada Clinic Respiratory Medicine & General Practice Himeji-shi
Japan Kamoike ENT allergy clinic Kagoshima
Japan Shinkomonji hospital Kitakyusyu
Japan Koyama Medical Clinic Nagano
Japan Tokyo Shinagawa Hospital Shinagawa-ku
Poland Gabinet Lekarski Pediatryczno-Alergologiczny Bialystok
Poland NZOZ Poradnie Specjalistyczne ATOPIA Krakow
Poland ETG Lodz Lodz
Poland Centrum Innowacyjnych Terapii Sp. z o.o. Piaseczno
Poland Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy Wroclaw
South Africa Clinical Trial Systems (Pty) Ltd Gauteng
South Africa Private Practice - Dr. Peter Sebastian KwaZulu-Natal
Spain Hosp. Gral. Univ. de Alicante Alicante
Spain Hosp. Quiron Barcelona Barcelona
Spain Hosp. Gral. Univ. de Elche Elche
Spain Clinica Univ. de Navarra Pamplona
Spain Hosp. Virgen Macarena Sevilla
Spain Hosp. Clinico Univ. De Valencia Valencia
Sweden PharmaSite Malmo
Sweden Skanes universitetssjukhus Malmö
Sweden ClinSmart Sweden AB Solna
Sweden Akademiska Sjukhuset Uppsala
Thailand The Hospital for Tropical Diseases Bangkok
Thailand Bamrasnaradura Infectious Disease Institute Nonthaburi
Thailand King Chulalongkorn Memorial Hospital Pathumwan
Ukraine Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education Kharkiv
Ukraine City Clinical Hospital #1 Kyiv
Ukraine Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' Kyiv
Ukraine Medical Center 'Consylium Medical' Kyiv
Ukraine Policlinic of State Joint Stock Holding Company 'Artem' Kyiv
Ukraine CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM Vinnytsia
United States IMD Clinical Trials Bakersfield California
United States Central Alabama Research Birmingham Alabama
United States Hope clinical Research LLC Canoga Park California
United States Dayton Clinical Research Dayton Ohio
United States Privia Medical Group, LLC Fayetteville Georgia
United States Javara Forest Virginia
United States Piedmont Clinical Research Fort Mill South Carolina
United States Texas Health Care, PLLC Fort Worth Texas
United States Best Quality Research Inc Hialeah Florida
United States New Life Medical Research Center, Inc. Hialeah Florida
United States Homestead Associates in Research, Inc Homestead Florida
United States Mercury Clinical Research Houston Texas
United States Next Level Urgent Care Houston Texas
United States SW Research LLC Houston Texas
United States Care Partners Clinical Research Jacksonville Florida
United States Excel Clinical Research Las Vegas Nevada
United States SMS Clinical Research LLC Mesquite Texas
United States Research Institute Of South Florida, Inc. Miami Florida
United States Montana Medical Research Missoula Montana
United States Burke Primary Care Morganton North Carolina
United States Frontier Clinical Research Morgantown West Virginia
United States Pines Care Research Center Inc Pembroke Pines Florida
United States Rio Grande Valley Clinical Research Institute Pharr Texas
United States Peninsula Research Associates Rolling Hills Estates California
United States Javara San Marcos Texas
United States Southcoast Health Savannah Georgia
United States CCT Research at South Ogden Family Medicine South Ogden Utah
United States Bensch Clinical Research, LLC Stockton California
United States Santos Research Center Tampa Florida
United States Fiel Family and Sports Medicine Clinical Research Advantage Tempe Arizona
United States Javara The Woodlands Texas
United States Renovatio Clinical The Woodlands Texas
United States Chesapeake Clinical Research, Inc. White Marsh Maryland
United States North Georgia Clinical Research Woodstock Georgia
United States Pulmonologist, Critical Care, and Sleep Medicine Wyomissing Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Germany,  Hungary,  Italy,  Japan,  Poland,  South Africa,  Spain,  Sweden,  Thailand,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at baseline were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. Baseline
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 3 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 3
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 8 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 8
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 14 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 14
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 21 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 21
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 28 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 28
Primary Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by the RiiQ symptom scale score at Day 35 were reported. The RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. In this outcome measure, only those individual participants who had data were reported. Day 35
Secondary Percentage of Participants With Post-Baseline RSV-related Complications RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases [such as COPD and asthma]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure [CHF] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this outcome measure. Up to Day 35
Secondary Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported. Up to Day 35
Secondary Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported. Up to Day 35
Secondary Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance Percentage of participants meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived. Up to Day 35
Secondary Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) An adverse events (AEs) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent. Up to Day 35
Secondary Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined as per division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild(transient or mild discomfort [less than {<} 48 hours]; no medical intervention/therapy required); Grade 2: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); Grade 4:life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). Only Grade 2 abnormalities are reported in this outcome measure. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Up to Day 35
Secondary Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs) Various ECG variables assessed were heart rate: abnormally low (less than or equal to [<=] 45 beats per minute [bpm]), abnormally high (greater than or equal to [>=] 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec); QTc: borderline prolonged: >450 msec and <=480 msec, prolonged: >480 msec and <=500 msec, pathologicaly prolonged: >500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Up to Day 35
Secondary Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings Abnormal vital parameters included pulse rate: abnormally low <=45 bpm, abnormally high >=120 bpm; Systolic Blood Pressure (SBP): abnormally low <=90 millimeter of mercury (mmHg), Grade 1 (mild): >140 mmHg to <160 mmHg, Grade 2 (moderate): >=160 mmHg to <180 mmHg, Grade 3 (severe): >=180 mmHg; Diastolic BP: abnormally low <=50 mmHg, Grade 1: >90 mmHg to <100 mmHg, Grade 2: >=100 mmHg to <110 mmHg, Grade 3: >=110 mmHg; Respiratory rate: Grade 1 (mild): 17-20 breaths per minute, Grade 2 (moderate): 21-25 breaths per minute, Grade 3 (severe): >25 breaths per minute, Grade 4 (potentially life threatening): intubation; Oxygen saturation: abnormally low: <95%; Temperature: abnormally high >38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Up to Day 35
Secondary RSV Viral Load Over Time RSV viral load (subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in the nasal swab specimens collected at the clinic visits and at home. In this outcome measure, only those timepoints and RSV subtypes (A or B) for which individual participants had data were reported. Baseline, Days 3, 5, 8, 15, and 21
Secondary Plasma Concentration of Rilematovir Plasma concentration of rilematovir was reported. This outcome measure was planned to be analyzed for specified arm only. In this outcome measure, only those timepoints for which individual participants had data were reported. Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8
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