Клинические исследование Respiratory Syncytial Virus: Rilematovir, Placebo

Спонсоры	Ведущий спонсор: Janssen Research & Development, LLC
Источник	Janssen Research & Development, LLC
Краткое содержание	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.

Подробное описание

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.

Общий статус

Recruiting

Дата начала

2021-11-17

Дата завершения

2023-12-21

Дата первичного завершения

2023-11-23

Фаза

Phase 2

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Time to Resolution of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ Symptom Scale)	From initiation of study treatment up to Day 35

Вторичный результат

Мера	Временное ограничение
Percentage of Participants with Post-Baseline RSV-related Complications	From initiation of study treatment up to Day 35
Percentage of Participants with New Antibiotic Use, or New or Increased Use in Bronchodilator/Nebulizer, Systemic Corticosteroids, or Home Oxygen Supplementation	From initiation of study treatment up to Day 35
Percentage of Participants with Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection	From initiation of study treatment up to Day 35
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance	From initiation of study treatment up to Day 35
Percentage of Participants with Adverse Events (AEs) as Measure of Safety and Tolerability	From initiation of study treatment up to Day 35
Percentage of Participants with Abnormalities in Clinical Laboratory Tests	From initiation of study treatment up to Day 35
Percentage of Participants with Abnormalities in Electrocardiograms (ECGs)	From initiation of study treatment up to Day 14
Percentage of Participants with Abnormalities in Physical Examination	From initiation of study treatment up to Day 35
Percentage of Participants with Abnormalities in Vital Signs	From initiation of study treatment up to Day 35
Change from Baseline Over Time in Severity of the RSV LRTD Symptoms as Assessed by the Participant Using the RiiQ Symptom Scale Score	Baseline up to Day 35
Time to Resolution of LRTD Symptoms and 2 Systemic symptoms as Assessed by RiiQ Symptom Scale Score	From initiation of study treatment up to Day 35
Time to Resolution of the Overall RSV Symptoms (Upper Respiratory Tract Disease [URTD], LRTD, and 2 Systemic Symptoms) as Assessed by RiiQ Symptom Scale Score	From initiation of study treatment up to Day 35
Time to Resolution of all RSV Symptoms as Assessed by RiiQ Symptom Scale Score	From initiation of study treatment up to Day 35
Time to Resolution of each Separate RSV LRTD Symptom as Assessed by RiiQ Symptom Scale Score	From initiation of study treatment up to Day 35
Time to Resolution of Respiratory Infection Symptoms as Assessed by Patient Global Impression of RSV Severity (PGI-S) Scale Score	From initiation of study treatment up to Day 35
Time to Return to Pre-existing Health (Status) for all RSV Symptoms as Assessed by RiiQ Symptom Scale Score	From initiation of study treatment up to Day 35
Time to Improvement in RSV Disease as Assessed by Patient Global Impression of Change (PGI-C) Scale Score	From initiation of study treatment up to Day 35
Change from Baseline Over Time for the Health-Related Quality of Life (HRQOL) as Assessed by 5 Level EuroQol 5 Dimension (EQ-5D-5L)	Baseline up to Day 35
Change from Baseline Over Time for the RiiQ Impact Scales	Baseline up to Day 35
Time to Return to Usual Health as Assessed by the 'Adult RSV Return to Usual Health' Question	From initiation of study treatment up to Day 35
Time to Return to Usual Activities as Assessed by the 'Adult RSV Return to Usual Activities' Question	From initiation of study treatment up to Day 35
Time to No or Mild Impact of RSV-related Disease on Daily Activities, Emotions, and Social Relationships as Assessed by RiiQ Impact Scales	From initiation of study treatment up to Day 35
RSV Viral Load Area Under the Curve (AUC) from Immediately Prior to First Dose of Study Intervention (Baseline) Through Days 3, 5 and 8	Baseline, Days 3, 5 and 8
Change from Baseline over Time in RSV Viral Load	Baseline up to Day 21
Percentage of Participants with Undetectable RSV Viral Load	From initiation of study treatment up to Day 21
Percentage of Participants with Post-baseline Sequence Changes in the RSV F Gene	From initiation of study treatment up to Day 21
Predose Plasma Concentration (Ctrough) of Rilematovir	Days 1, 3 and 8
Maximum Plasma Concentration (Cmax) of Rilematovir	Days 1, 3 and 8
Area Under the Curve of Administration of Rilematovir up to 12 hours Post Dosing (AUC[0-12h])	Days 1, 3 and 8
Percentage of Participants with Number and Type of Medical Encounters	From initiation of study treatment up to Day 35
Percentage of Participants with Shift in any Care Setting	From initiation of study treatment up to Day 35
Percentage of Participants Requiring Hospitalization for Respiratory or Other Reasons	From initiation of study treatment up to Day 35
Duration of Hospitalization	From initiation of study treatment up to Day 35
Percentage of Participants with Treatment-emergent Use of Antibiotics	From initiation of study treatment up to Day 35
Duration of Treatment-emergent Use of Antibiotics	From initiation of study treatment up to Day 35
Percentage of Participants with Treatment-emergent New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilators	From initiation of study treatment up to Day 35
Duration of Treatment-emergent New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilators	From initiation of study treatment up to Day 35
Percentage of Participants with New or Increased Use of Oxygen Therapy	From initiation of study treatment up to Day 35
Duration of Oxygen Supplementation	From initiation of study treatment up to Day 35
Duration of Selected Post-baseline Emergent (After Start of Study Intervention) Medical Resource Utilization	From initiation of study treatment up to Day 35

Регистрация

180

Состояние	Respiratory Syncytial Virus
Вмешательство	Тип вмешательства: Drug Название вмешательства: Rilematovir Описание: Rilematovir 250 mg will be administered orally. Этикетка Arm Group: Treatment A: Rilematovir Другое имя: JNJ-53718678 Тип вмешательства: Drug Название вмешательства: Placebo Описание: Placebo matching to rilematovir will be administered orally. Этикетка Arm Group: Treatment B: Placebo
Приемлемость	Критерии: 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 Пол: All Минимальный возраст: 18 Years Максимальный возраст: 85 Years Здоровые волонтеры: No

Состояние

Respiratory Syncytial Virus

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Rilematovir

Описание: Rilematovir 250 mg will be administered orally.

Этикетка Arm Group: Treatment A: Rilematovir

Другое имя: JNJ-53718678

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Placebo matching to rilematovir will be administered orally.

Этикетка Arm Group: Treatment B: Placebo

Приемлемость

Критерии:

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

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

85 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Janssen Research & Development, LLC Clinical Trial	Study Director	Janssen Research & Development, LLC

Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение

Объект:	Положение дел:
Central Alabama Research \| Birmingham, Alabama, 35209, United States	Recruiting
Cahaba Research Inc \| Birmingham, Alabama, 35235, United States	Withdrawn
Cahaba Research Inc \| Birmingham, Alabama, 35242, United States	Withdrawn
Synexus Clinical Research US, Inc \| Glendale, Arizona, 85308, United States	Withdrawn
Fiel Family and Sports Medicine Clinical Research Advantage \| Tempe, Arizona, 85283, United States	Recruiting
IMD Clinical Trials \| Bakersfield, California, 93309, United States	Recruiting
Hope clinical Research LLC \| Canoga Park, California, 91303, United States	Not yet recruiting
Velocity Clinical Research, Inc. \| Chula Vista, California, 91911, United States	Not yet recruiting
Peninsula Research Associates \| Rolling Hills Estates, California, 90274, United States	Not yet recruiting
Bensch Clinical Research, LLC \| Stockton, California, 95207, United States	Not yet recruiting
Moonshine Research Center, Inc \| Doral, Florida, 33166, United States	Withdrawn
New Life Medical Research Center, Inc. \| Hialeah, Florida, 33012, United States	Not yet recruiting
Best Quality Research Inc \| Hialeah, Florida, 33016, United States	Recruiting
Homestead Associates in Research, Inc \| Homestead, Florida, 33032, United States	Not yet recruiting
Care Partners Clinical Research \| Jacksonville, Florida, 32277, United States	Recruiting
South Florida Research Center Inc. \| Miami, Florida, 33135, United States	Not yet recruiting
Advanced Pharma CR, LLC \| Miami, Florida, 33147, United States	Withdrawn
Alma Clinical Research \| Miami, Florida, 33165, United States	Withdrawn
Research Institute Of South Florida, Inc. \| Miami, Florida, 33173, United States	Recruiting
Southeast Cinical Research \| Ocala, Florida, 34476, United States	Withdrawn
Pines Care Research Center Inc \| Pembroke Pines, Florida, 33024, United States	Recruiting
Andres Patron D.O. P.A. \| Pembroke Pines, Florida, 33026, United States	Withdrawn
Pines Care Research Center Inc \| Pembroke Pines, Florida, 33026, United States	Withdrawn
Santos Research Center \| Tampa, Florida, 33615, United States	Recruiting
Privia Medical Group, LLC \| Albany, Georgia, 31707, United States	Not yet recruiting
Privia Medical Group, LLC \| Fayetteville, Georgia, 30214, United States	Not yet recruiting
Pramukh Clinical Research, LLC \| Roswell, Georgia, 30076, United States	Not yet recruiting
Southcoast Health \| Savannah, Georgia, 31406, United States	Recruiting
North Georgia Clinical Research \| Woodstock, Georgia, 30189, United States	Recruiting
Clinical Research Prime \| Idaho Falls, Idaho, 83404, United States	Withdrawn
Medpharmics, LLC \| Metairie, Louisiana, 70006, United States	Withdrawn
Privia Medical Group, LLC \| Glenn Dale, Maryland, 20768, United States	Withdrawn
Chesapeake Clinical Research, Inc. \| White Marsh, Maryland, 21162, United States	Recruiting
Washington University School of Medicine \| Saint Louis, Missouri, 63110, United States	Withdrawn
Mercury Street Medical \| Butte, Montana, 59701, United States	Withdrawn
Montana Medical Research \| Missoula, Montana, 59808, United States	Recruiting
Prairie Fields Family Medicine \| Fremont, Nebraska, 68025, United States	Withdrawn
Meridian Clinical Research, LLC \| Grand Island, Nebraska, 68803, United States	Withdrawn
Excel Clinical Research \| Las Vegas, Nevada, 89109, United States	Not yet recruiting
Meridian Clinical Research, LLC \| Endwell, New York, 13760, United States	Withdrawn
Wake Forest Baptist Health Urgent Care Clemmons \| Clemmons, North Carolina, 27103, United States	Not yet recruiting
Wake Forest Health Network \| Mocksville, North Carolina, 27028, United States	Withdrawn
Burke Primary Care \| Morganton, North Carolina, 28655, United States	Recruiting
Dayton Clinical Research \| Dayton, Ohio, 45406, United States	Recruiting
Geisinger Medical Center \| Danville, Pennsylvania, 17622, United States	Not yet recruiting
Pulmonologist, Critical Care, and Sleep Medicine \| Wyomissing, Pennsylvania, 19610, United States	Recruiting
Piedmont Clinical Research \| Fort Mill, South Carolina, 29707, United States	Recruiting
VitaLink Research Spartanburg \| Spartanburg, South Carolina, 29303, United States	Withdrawn
Texas Health Care, PLLC \| Fort Worth, Texas, 76133, United States	Recruiting
Mercury Clinical Research \| Houston, Texas, 77027, United States	Not yet recruiting
Next Level Urgent Care \| Houston, Texas, 77057, United States	Recruiting
SW Research LLC \| Houston, Texas, 77081, United States	Recruiting
Valley Pulmonary Group \| McAllen, Texas, 78503, United States	Withdrawn
SMS Clinical Research LLC \| Mesquite, Texas, 75149, United States	Recruiting
Rio Grande Valley Clinical Research Institute \| Pharr, Texas, 78577, United States	Not yet recruiting
Javara \| San Marcos, Texas, 78666, United States	Recruiting
Renovatio Clinical \| The Woodlands, Texas, 77380, United States	Recruiting
Privia Medical Group, LLC \| The Woodlands, Texas, 77382, United States	Not yet recruiting
Javara \| The Woodlands, Texas, 77384, United States	Recruiting
CCT Research at Olympus Family Medicine \| Holladay, Utah, 84117, United States	Not yet recruiting
CCT Research at South Ogden Family Medicine \| South Ogden, Utah, 84405, United States	Recruiting
Privia Medical Group, LLC \| Appomattox, Virginia, 24522, United States	Withdrawn
Javara \| Forest, Virginia, 24551, United States	Not yet recruiting
Multicare Institute For Research & Innovation - Rockwood Clinic - Cheney \| Cheney, Washington, 99004, United States	Not yet recruiting
MultiCare Institue for Research & Innovation \| Spokane, Washington, 99204, United States	Withdrawn
Frontier Clinical Research \| Morgantown, West Virginia, 26505, United States	Not yet recruiting
Hospital Español De Bahia Blanca \| Bahia Blanca, 8000, Argentina	Withdrawn
CARE - Centro de Alergia y Enfermedades Respiratorias \| Ciudad Autonoma de Buenos Aires, 1414, Argentina	Withdrawn
Fundación CENIT para la Investigación en Neurociencias \| Ciudad Autónoma de Buenos Aires, 1125, Argentina	Withdrawn
INAER - Investigación en Alergias y Enfermedades Respiratorias \| Ciudad Autónoma de Buenos Aires, 1425, Argentina	Not yet recruiting
Instituto DAMIC \| Córdoba Capital, 5000, Argentina	Not yet recruiting
IERIM - Instituto de Enfermedades Respiratorias e Investigación Médica \| Florencio Varela, 1888, Argentina	Not yet recruiting
Instituto FIDES \| La Plata, 1900, Argentina	Not yet recruiting
Ave Pulmo \| Mar Del Plata, B7602DCK, Argentina	Withdrawn
Centro Respiratorio Quilmes \| Quilmes, 1878, Argentina	Not yet recruiting
Centro Medico Respire \| San Fernando, 1646, Argentina	Not yet recruiting
Clinica Mayo de UMCB \| San Miguel de Tucuman, T4000IHE, Argentina	Not yet recruiting
Centro Modelo de Cardiologia \| San Miguel de Tucumán, 4000, Argentina	Withdrawn
Investigaciones en Patologias Respiratorias \| San Miguel de Tucumán, 4000, Argentina	Not yet recruiting
CESIM - Centro de Salud e Investigaciones Médicas \| Santa Rosa, L6300, Argentina	Withdrawn
CEMER - Centro Médico de Enfermedades Respiratorias \| Vicente López, 1602, Argentina	Withdrawn
Hospital Felício Rocho \| Belo Horizonte, 30110-060, Brazil	Not yet recruiting
L2IP - Instituto de Pesquisas Clínicas \| Brasília, 70200-730, Brazil	Not yet recruiting
Fundação Universidade de Caxias do Sul \| Caxias do Sul, 95070 560, Brazil	Not yet recruiting
Hospital São José \| Criciúma, 88801-250, Brazil	Not yet recruiting
Servico de Infectologia e Controle de Infeccao Hospitalar de Curitiba-Centro Medico Sao Francisco \| Curitiba, 80810-050, Brazil	Not yet recruiting
Centro de Estudos e Pesquisas em Moléstias Infecciosas \| Natal, 59025-050, Brazil	Not yet recruiting
Hospital Nossa Senhora da Conceicao \| Porto Alegre, 91350-200, Brazil	Not yet recruiting
Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ \| Rio de Janeiro, 21040-360, Brazil	Not yet recruiting
Centro de Psiquiatria e Pesquisas Sandra Ruschel \| Rio de Janeiro, 22270-060, Brazil	Not yet recruiting
Pesquisare Saude \| Santo André, 09080-110, Brazil	Not yet recruiting
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo \| Haskovo, 6300, Bulgaria	Not yet recruiting
MHAT 'Sv. Ivan Rilski' Kozloduy EOOD \| Kozloduy, 3320, Bulgaria	Withdrawn
MHAT Stamen Iliev AD \| Montana, 3400, Bulgaria	Not yet recruiting
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik \| Pernik, 2000, Bulgaria	Not yet recruiting
SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD \| Ruse, 7002, Bulgaria	Not yet recruiting
Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD \| Troyan, 5600, Bulgaria	Not yet recruiting
MC 'Sv. Ivan Rilski', OOD \| Vidin, 3700, Bulgaria	Withdrawn
Dr. Anil K Gupta Medicine Professional Corporation \| Toronto, Ontario, M9V 4B4, Canada	Recruiting
Universitatsklinikum Bonn \| Bonn, 53105, Germany	Not yet recruiting
IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum \| Frankfurt, 60596, Germany	Recruiting
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut \| Leipzig, 04249, Germany	Not yet recruiting
Praxis Dr. Weimer \| Reinfeld, 23858, Germany	Recruiting
MediSlim GmbH \| Weinheim, 69469, Germany	Withdrawn
Csaladgyogyasz Kft \| Budapest, 1083, Hungary	Withdrawn
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo - Tudogondozo Intezet es Szuroallomas \| Budapest, 1122, Hungary	Not yet recruiting
Strázsahegy Medicina Bt \| Budapest, 1171, Hungary	Recruiting
Omnimodus Elixír Kft. \| Csorna, 9300, Hungary	Recruiting
Apollo Hospitals \| Chennai, 600095, India	Withdrawn
Hindusthan Hospital \| Coimbatore, 641028, India	Withdrawn
Medica Superspecialty Hospital \| Kolkata, 700099, India	Withdrawn
Vinaya Hospital and Research Center \| Mangalore, 575003, India	Not yet recruiting
Kasturba Medical College Hospital \| Manipal, 576104, India	Withdrawn
Lata Mangeshkar Hospital \| Nagpur, 440010, India	Not yet recruiting
Supe Heart And Diabetes Hospital and Research Center \| Nashik, 0422002, India	Withdrawn
Sir Ganga Ram Hospital \| New Delhi, 110060, India	Withdrawn
Lifepoint Multispecialty Hospital \| Pune, 411057, India	Withdrawn
Unity Hospital \| Surat, 0395010, India	Withdrawn
BAPS Pramukhswami Hospital \| Surat, 395009, India	Not yet recruiting
Azienda Ospedaliera - Polo Universitario San Paolo \| Milano, 20142, Italy	Not yet recruiting
AOU Di Modena, Policlinico Di Modena \| Modena, 41124, Italy	Not yet recruiting
Ospedale Monaldi \| Napoli, 80131, Italy	Not yet recruiting
Fondazione IRCCS Policlinico San Matteo \| Pavia, 27100, Italy	Not yet recruiting
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli' \| Roma, 00168, Italy	Not yet recruiting
Nishifukuoka Hospital \| Fukuoka, 819-8555, Japan	Not yet recruiting
Nagata Hospital \| Fukuoka, 832-0059, Japan	Not yet recruiting
Terada Clinic Respiratory Medicine & General Practice \| Himeji-shi, 670-0849, Japan	Not yet recruiting
Kamoike ENT allergy clinic \| Kagoshima, 890-0063, Japan	Not yet recruiting
Shinkomonji hospital \| Kitakyusyu, 800-0057, Japan	Not yet recruiting
Koyama Medical Clinic \| Nagano, 390-0872, Japan	Not yet recruiting
Okayama City General Medical Center Okayama City Hospital \| Okayama, 700-8557, Japan	Not yet recruiting
Tokyo Shinagawa Hospital \| Shinagawa-ku, 140-8522, Japan	Not yet recruiting
KKR Takamatsu Hospital \| Takamatsu-shi, 760-0018, Japan	Not yet recruiting
Azuma Clinic \| Tokyo, 130-0002, Japan	Not yet recruiting
National Hospital Organization Kasumigaura Medical Center \| Tsuchiura-city, 300-8585, Japan	Not yet recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde \| Guadalajara, 44280, Mexico	Not yet recruiting
Hospital Civil de Guadalajara Dr. Juan I. Menchaca \| Gualajadara, 44340, Mexico	Not yet recruiting
RM Pharma Specialists \| Mexico, 03100, Mexico	Not yet recruiting
CRI Centro Regiomontano de Investigación S.C \| Monterrey, 64060, Mexico	Not yet recruiting
Gabinet Lekarski Pediatryczno-Alergologiczny \| Bialystok, 15-430, Poland	Recruiting
NZOZ Poradnie Specjalistyczne ATOPIA \| Krakow, 31159, Poland	Recruiting
SP ZOZ w Lecznej \| Leczna, 21-010, Poland	Suspended
ETG Lodz \| Lodz, 90-302, Poland	Recruiting
Centrum Innowacyjnych Terapii Sp. z o.o. \| Piaseczno, 05500, Poland	Recruiting
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy \| Wroclaw, 51-162, Poland	Recruiting
City Polyclinic #25 of the Nevsky District of SPB \| Saint-Petersburg, 193312, Russian Federation	Not yet recruiting
Eco-safety Ltd \| Saint-Petersburg, 196143, Russian Federation	Withdrawn
Saint-Petersburg State Budgetary Healthcare Institution 'City Polyclinic #106' \| Saint-Petersburg, 198328, Russian Federation	Not yet recruiting
LLC 'Terafarm' \| Stavropol, 355000, Russian Federation	Not yet recruiting
State Autonomous Healthcare Institution of the Yaroslavl Region "Clinical Hospital #9" \| Yaroslavl, 150042, Russian Federation	Not yet recruiting
Ndlovu Elandsdoorn Site \| Dennilton, 0485, South Africa	Not yet recruiting
Queenswood Clinical Trial Centre \| Gauteng, 0001, South Africa	Not yet recruiting
MERC Kempton Park \| Gauteng, 1619, South Africa	Not yet recruiting
Ahmed Alkadi Hospital \| KwaZulu-Natal, 4058, South Africa	Not yet recruiting
Private Practice - Dr. Peter Sebastian \| KwaZulu-Natal, 4092, South Africa	Not yet recruiting
Mzansi Ethical Research Centre \| Middelburg, 1055, South Africa	Not yet recruiting
Global Clin Trials Pretoria \| Pretoria, 0001, South Africa	Not yet recruiting
Hosp. Gral. Univ. de Alicante \| Alicante, 3010, Spain	Not yet recruiting
Hospital Quiron Barcelona \| Barcelona, 08023, Spain	Recruiting
Hosp. Gral. Univ. de Elche \| Elche, 03203, Spain	Recruiting
Clinica Univ. de Navarra \| Madrid, 28027, Spain	Not yet recruiting
Clinica Univ. de Navarra \| Pamplona, 31008, Spain	Not yet recruiting
Hosp. Univ. Marques de Valdecilla \| Santander, 39008, Spain	Not yet recruiting
Hosp. Virgen Macarena \| Sevilla, 41009, Spain	Recruiting
Hosp. Clinico Univ. de Valencia \| Valencia, 46010, Spain	Recruiting
PharmaSite Helsingborg \| Helsingborg, 25220, Sweden	Withdrawn
PharmaSite \| Malmo, 21152, Sweden	Recruiting
Skanes universitetssjukhus \| Malmö, 20502, Sweden	Recruiting
ClinSmart Sweden AB \| Solna, 171 64, Sweden	Recruiting
Akademiska Sjukhuset \| Uppsala, 75185, Sweden	Recruiting
The Hospital for Tropical Diseases \| Bangkok, 10400, Thailand	Recruiting
Bamrasnaradura Infectious Disease Institute \| Nonthaburi, 11000, Thailand	Recruiting
King Chulalongkorn Memorial Hospital \| Pathumwan, 10330, Thailand	Recruiting
Hacettepe University Medical Faculty \| Ankara, 06100, Turkey	Not yet recruiting
Kocaeli University Medical Faculty \| Kocaeli, 41001, Turkey	Not yet recruiting
Acibadem Mehmet Ali Aydinlar University \| Kucukcekmece, 34303, Turkey	Not yet recruiting
Karadeniz Teknik University Medical Faculty \| Trabzon, 61080, Turkey	Not yet recruiting
Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital \| Ivano-Frankivsk, 76007, Ukraine	Withdrawn
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital \| Ivano-Frankivsk, 76018, Ukraine	Withdrawn
Medical Center of LL Company 'Scientific Medical Center-Your Doctor' \| Kharkiv, 61103, Ukraine	Withdrawn
Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education \| Kharkiv, 61106, Ukraine	Not yet recruiting
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh' \| Kherson, 73000, Ukraine	Withdrawn
Medical Center LLC 'Harmony of Beauty' \| Kyiv, 01135, Ukraine	Withdrawn
City Clinical Hospital #1 \| Kyiv, 02091, Ukraine	Not yet recruiting
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway' \| Kyiv, 03049, Ukraine	Not yet recruiting
Medical Center 'Consylium Medical' \| Kyiv, 04050, Ukraine	Not yet recruiting
Policlinic of State Joint Stock Holding Company 'Artem' \| Kyiv, 04050, Ukraine	Not yet recruiting
Volyn Regional Clinical Hospital \| Lutsk, 43005, Ukraine	Withdrawn
City Policlinic #20 \| Odesa, 65114, Ukraine	Withdrawn
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy \| Poltava, 36000, Ukraine	Withdrawn
1-A City Clinical Hospital - Ukrainian Medical Stomatology Academy \| Poltava, 36038, Ukraine	Withdrawn
MNPE Central City Hospital of Rivne City Council, Medical and Diagnostic Hepatological Center \| Rivne, 33018, Ukraine	Withdrawn
Ternopil City Municipal Emergency Hospital Infectious Dept. with Ward of Intensive Care \| Ternopil, 46008, Ukraine	Withdrawn
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM \| Vinnytsia, 21029, Ukraine	Not yet recruiting
VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council \| Vinnytsya, 21018, Ukraine	Withdrawn
KU 6 miska klinichna likarnia ZMR \| Zaporizhzhia, 69035, Ukraine	Withdrawn
Zhytomyr Central City Hospital #1 \| Zhytomyr, 10002, Ukraine	Withdrawn

Расположение Страны	Argentina Brazil Bulgaria Canada Germany Hungary India Italy Japan Mexico Poland Russian Federation South Africa Spain Sweden Thailand Turkey Ukraine United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	Yes
Состояние Просмотр	Infections Virus Diseases
Количество рук	2
Группа вооружений	Метка: Treatment A: Rilematovir Тип: Experimental Описание: Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days. Метка: Treatment B: Placebo Тип: Placebo Comparator Описание: Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days.
Акроним	PRIMROSE
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Double (Participant, Investigator)

A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection