Respiratory Syncytial VirusPhase 2PRIMROSENCT04978337
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
A Phase 2 study testing Rilematovir in people with Respiratory Syncytial Virus, run by Janssen Research & Development, LLC at 86 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- Rilematovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 86 sitesin 14 countries
- Study dates
- 17 Nov 2021to 31 Mar 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
86 sites in 14 countries.
86 sites in 14 countries
United States35 sites
IMD Clinical Trials
Bakersfield, California, 93309
Central Alabama Research
Birmingham, Alabama, 35209
Hope clinical Research LLC
Canoga Park, California, 91303
Dayton Clinical Research
Dayton, Ohio, 45409
Privia Medical Group, LLC
Fayetteville, Georgia, 30214
Javara
Forest, Virginia, 24551
Piedmont Clinical Research
Fort Mill, South Carolina, 29707
Texas Health Care, PLLC
Fort Worth, Texas, 76133
New Life Medical Research Center, Inc.
Hialeah, Florida, 33012
Best Quality Research Inc
Hialeah, Florida, 33016
Homestead Associates in Research, Inc
Homestead, Florida, 33032
Mercury Clinical Research
Houston, Texas, 77027
Next Level Urgent Care
Houston, Texas, 77057
SW Research LLC
Houston, Texas, 77081
Care Partners Clinical Research
Jacksonville, Florida, 32277
Excel Clinical Research
Las Vegas, Nevada, 89109
SMS Clinical Research LLC
Mesquite, Texas, 75149
Research Institute Of South Florida, Inc.
Miami, Florida, 33173
Montana Medical Research
Missoula, Montana, 59808
Burke Primary Care
Morganton, North Carolina, 28655
Frontier Clinical Research
Morgantown, West Virginia, 26505
Pines Care Research Center Inc
Pembroke Pines, Florida, 33024
Rio Grande Valley Clinical Research Institute
Pharr, Texas, 78577
Peninsula Research Associates
Rolling Hills Estates, California, 90274
Javara
San Marcos, Texas, 78666
Southcoast Health
Savannah, Georgia, 31406
CCT Research at South Ogden Family Medicine
South Ogden, Utah, 84405
Bensch Clinical Research, LLC
Stockton, California, 95207
Santos Research Center
Tampa, Florida, 33615
Fiel Family and Sports Medicine Clinical Research Advantage
Tempe, Arizona, 85283
Renovatio Clinical
The Woodlands, Texas, 77380
Javara
The Woodlands, Texas, 77384
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
North Georgia Clinical Research
Woodstock, Georgia, 30189
Pulmonologist, Critical Care, and Sleep Medicine
Wyomissing, Pennsylvania, 19610
Japan7 sites
Nishifukuoka Hospital
Fukuoka, 819-8555
Nagata Hospital
Fukuoka, 832-0059
Terada Clinic Respiratory Medicine & General Practice
Himeji-shi, 670-0849
Kamoike ENT allergy clinic
Kagoshima, 890-0063
Shinkomonji hospital
Kitakyushu, 800-0057
Koyama Medical Clinic
Nagano, 390-0872
Tokyo Shinagawa Hospital
Shinagawa-ku, 140-8522
Spain6 sites
Hosp. Gral. Univ. de Alicante
Alicante, 3010
Hosp. Quiron Barcelona
Barcelona, 08023
Hosp. Gral. Univ. de Elche
Elche, 03203
Clinica Univ. de Navarra
Pamplona, 31008
Hosp. Virgen Macarena
Seville, 41009
Hosp. Clinico Univ. De Valencia
Valencia, 46010
Ukraine6 sites
Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
Kharkiv, 61106
City Clinical Hospital #1
Kyiv, 02091
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Kyiv, 03049
Medical Center 'Consylium Medical'
Kyiv, 04050
Policlinic of State Joint Stock Holding Company 'Artem'
Kyiv, 04050
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21029
Argentina5 sites
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires, 1425
Centro Respiratorio Quilmes
Quilmes, 1878
Centro Medico Respire
San Fernando, 1646
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, 4000
Clinica Mayo de UMCB
San Miguel de Tucumán, T4000IHE
Poland5 sites
Gabinet Lekarski Pediatryczno-Alergologiczny
Bialystok, 15-430
NZOZ Poradnie Specjalistyczne ATOPIA
Krakow, 31159
ETG Lodz
Lodz, 90-302
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, 05500
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
Wroclaw, 51-162
Bulgaria4 sites
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo Ltd. Haskovo
Haskovo, 6300
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
Pernik, 2000
SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
Rousse, 7002
Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
Troyan Municipality, 5600
Germany4 sites
Universitatsklinikum Bonn
Bonn, 53105
IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
Frankfurt, 60596
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
Leipzig, 04249
Praxis Dr. Weimer
Reinfeld, 23858
Sweden4 sites
Skanes universitetssjukhus
Malmö, 20502
PharmaSite
Malmö, 21152
ClinSmart Sweden AB
Solna, 171 64
Akademiska Sjukhuset
Uppsala, 75185
Thailand3 sites
The Hospital for Tropical Diseases
Bangkok, 10400
Bamrasnaradura Infectious Disease Institute
Nonthaburi, 11000
King Chulalongkorn Memorial Hospital
Pathumwan, 10330
Hungary2 sites
Strázsahegy Medicina Bt
Budapest, 1171
Omnimodus Elixír Kft.
Csorna, 9300
Italy2 sites
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'
Roma, 00168
South Africa2 sites
Clinical Trial Systems (Pty) Ltd
Gauteng, 0001
Private Practice - Dr. Peter Sebastian
KwaZulu-Natal, 4092
Canada1 site
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4
About this study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression
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.
Read the detailed 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.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Rilematovir, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilematovirDrug
Also called JNJ-53718678
Rilematovir 250 mg will be administered orally.
PlaceboDrug
Placebo matching to rilematovir will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Rilematovir | Experimental | Participants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days. Receives: Drug: Rilematovir |
| Treatment B: Placebo | Placebo comparator | Participants will receive oral dose of placebo matching to rilematovir, bid for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Day 3
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.
Measured: Day 8
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.
Measured: Day 14
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.
Measured: Day 21
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.
Measured: Day 28
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.
Measured: Day 35
Secondary outcomes (10)
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Up to Day 35
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.
Measured: Baseline, Days 3, 5, 8, 15, and 21
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.
Measured: Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start17 Nov 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Why it stopped: Janssen made the strategic decision to discontinue the PRIMROSE study. This decision is not based on any safety concerns.
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.
- Other trials for Respiratory Syncytial VirusStudies 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
- 5 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
- NCT04978337
- Sponsor's protocol ID
- CR109031
- Other IDs
- 53718678RSV2008, 2020-005980-30
- Acronym
- PRIMROSE
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2021
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection Who Are at High Risk for RSV-related Disease Progression
- ClinicalTrials.gov ID
- NCT04978337
- Acronym / sponsor ID
- PRIMROSE / CR109031
- Conditions
- Respiratory Syncytial Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Janssen made the strategic decision to discontinue the PRIMROSE study. This decision is not based on any safety concerns.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 21 Apr 2023
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 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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Rilematovir | Experimental | Drug: RilematovirParticipants will receive oral dose of rilematovir 250 milligrams (mg), twice daily (bid) for 7 days. |
| Treatment B: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive oral dose of placebo matching to rilematovir, bid for 7 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| RilematovirAlso: JNJ-53718678Rilematovir 250 mg will be administered orally. | Drug | Treatment A: Rilematovir |
| PlaceboPlacebo matching to rilematovir will be administered orally. | Drug | Treatment B: Placebo |
Primary outcome
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
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
Time frame: 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.
10 secondary outcomes
Percentage of Participants With Post-Baseline RSV-related Complications
Time frame: Up to Day 35
Percentage of Participants With New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation
Time frame: Up to Day 35
Percentage of Participants With Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection
Time frame: Up to Day 35
Percentage of Participants Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance
Time frame: Up to Day 35
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 35
Percentage of Participants With Treatment-emergent Abnormal Clinical Laboratory Findings
Time frame: Up to Day 35
Percentage of Participants With Treatment-emergent Abnormalities in Electrocardiograms (ECGs)
Time frame: Up to Day 35
Percentage of Participants With Treatment-emergent Abnormal Vital Signs Findings
Time frame: Up to Day 35
RSV Viral Load Over Time
Time frame: Baseline, Days 3, 5, 8, 15, and 21
Plasma Concentration of Rilematovir
Time frame: Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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
86 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilematovir in people with Respiratory Syncytial Virus, run by Janssen Research & Development, LLC at 86 sites in 14 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Japan, Spain, Ukraine, Argentina and 9 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 21 Apr 2023). 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?
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 (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2024.