Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Participants Hospitalized With Respiratory Syncytial Virus

December 23, 2019 updated by: Janssen Research & Development, LLC

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine Regimens in Adult Subjects Hospitalized With Respiratory Syncytial Virus

The purpose of this study is to characterize the Pharmacokinetic and to confirm the popPK model derived from healthy volunteers in hospitalized adults who are infected with respiratory syncytial virus (RSV) and to determine in adults who are hospitalized with respiratory syncytial virus (RSV) infection the dose response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase-polymerase chain reaction (qRT-PCR) assay.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be conducted in 3 phases: a screening phase, a treatment phase from Day 1 to Day 5/6 (depending on the timing of the loading dose), and a follow-up phase for a total of 28 days post randomization. Participants will have assessments completed at Day 7, Day 10, Day 14, and Day 28. Depending on discharge date, assessments will be completed either while hospitalized or during outpatient visits. The duration of the participant's participation will be approximately 28 days. The study will be performed in 2 parts. Participants will be randomly assigned to one of 2 treatment groups in part 1, and to one of 3 treatment groups in part 2. Treatment groups will be evaluated for PK and safety after a target of approximately 24 participants have been enrolled in part 1 and before initiating part 2 (approximately 90 participants in part 2). An Independent Data Monitoring Committee (IDMC) will be established to monitor the safety of participants and will review data in an unblinded manner on a regular basis to ensure the continuing safety of the participants enrolled in this study and to evaluate whether efficacy objectives are met. The committee will meet periodically to review interim data. Based on the recommendations of the IDMC following interim analyses/reviews, an increase in duration may be implemented.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
      • Barrio Parque Velez Sarfield, Argentina
      • Buenos Aires, Argentina
      • Ciudad De La Plata, Argentina
      • Ciudad de Buenos Aires, Argentina
      • Cordoba, Argentina
      • Córdoba, Argentina
      • La Plata, Argentina
      • Rosario, Argentina
  • Australia
      • Cairns, Australia
      • Geelong, Australia
      • Melbourne, Australia
      • South Brisbane, Australia
      • Sydney, Australia
  • Belgium
      • Brugge, Belgium
      • Lier, Belgium
  • Brazil
      • Belo Horizonte, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Sao Paulo, Brazil
  • Bulgaria
      • Kozloduy, Bulgaria
      • Petrich, Bulgaria
      • Ruse, Bulgaria
      • Sofia, Bulgaria
      • Veliko Tarnovo, Bulgaria
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Toronto, Ontario, Canada
  • France
      • Colombes, France
      • Dijon, France
      • La Tronche, France
      • Limoges, France
      • Lyon, France
      • Morlaix, France
      • Nantes, France
      • Paris, France
      • Poitiers, France
      • Suresnes, France
      • Tours, France
  • Germany
      • Marburg, Germany
      • Witten, Germany
  • Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Gifu, Japan
      • Gunma, Japan
      • Hamamatue, Japan
      • Isahaya, Japan
      • Izumo, Japan
      • Kitakyusyu, Japan
      • Kobe-city,, Japan
      • Nagasaki, Japan
      • Nagoya, Japan
      • Osaka, Japan
      • Ota, Japan
      • Sendai, Japan
      • Seto, Japan
      • Shiogama, Japan
      • Tanabe, Japan
      • Tokai-mura, Japan
      • Tokyo, Japan
      • Tsu, Japan
      • Uruma, Japan
  • Korea, Republic of
      • Bucheon, Korea, Republic of
      • Daegu, Korea, Republic of
      • Gwangju, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
  • Malaysia
      • Johor Bharu, Malaysia
      • Kuala, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuching, Malaysia
      • Melaka, Malaysia
      • Miri, Malaysia
      • Taiping, Malaysia
  • Mexico
      • Cuernavaca, Mexico
      • Guadalajara, Mexico
      • Mexico, Mexico
      • Monterrey, Mexico
  • Netherlands
      • Leiden, Netherlands
      • Utrecht, Netherlands
  • Poland
      • Białystok, Poland
      • Chęciny, Poland
      • Mrozy, Poland
      • Proszowice, Poland
  • Spain
      • Elche, Spain
      • Granada, Spain
      • Madrid, Spain
      • Santiago de Compostela, Spain
      • Vigo, Spain
  • Sweden
      • Göteborg, Sweden
      • Malmö, Sweden
      • Umeå, Sweden
      • Uppsala, Sweden
  • Taiwan
      • Kaohsiung, Taiwan
      • New Taipei, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • United Kingdom
      • London, United Kingdom
      • Southampton, United Kingdom
  • United States
    • California
      • Fresno, California, United States
      • Orange, California, United States
      • Stanford, California, United States
    • Florida
      • Eustis, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • New York
      • Rochester, New York, United States
      • Syracuse, New York, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hospitalized (or in emergency room prior to hospitalization) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization
  • Diagnosed with respiratory syncytial virus (RSV) infection based on polymerase chain reaction (PCR)-based assay with or without co infection with another respiratory pathogen (eg, influenza, human metapneumovirus, or bacteria)
  • With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator
  • A woman must have a negative urine beta human chorionic gonadotropin at screening
  • A woman must agree not to donate eggs (ova, oocytes) during the study and for at least 44 days after receiving the last dose of study drug
  • Contraceptive use by women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies A woman must be of non-childbearing potential defined as either: a) Postmenopausal: a postmenopausal state is defined as more than (>) 45 years and no menses for 12 consecutive months without an alternative medical cause, OR Permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), and bilateral oophorectomy. b) Of childbearing potential and, if heterosexually active, also included: practicing a highly effective method of contraception (failure rate of less than (<) 1percent (%) per year when used consistently and correctly)
  • Participants must have a body weight of at least 50.0 kilogram, at screening

Exclusion Criteria:

  • Participants who are not expected to survive for more than 48 hours
  • Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization
  • Participants who are considered by the investigator to be immuno-compromised within the past 12 months, whether due to underlying medical condition (example, malignancy or genetic disorder) or medical therapy (example, medications other than corticosteroids for the treatment of chronic obstructive pulmonary disease (COPD) or asthma exacerbations, chemotherapy, radiation, stem cell or solid organ transplant)
  • Participants with a known history of human immunodeficiency virus (HIV) or chronic viral hepatitis
  • Participants undergoing peritoneal dialysis, hemodialysis, or hemofiltration or with an estimated glomerular filtration rate (GFR, determined by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) of (<) 60 milliliters per minute (mL/min) per 1.73 meter square (m^2)
  • Participants with 1 or more of the following laboratory abnormalities at screening as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table: Hemoglobin <9.5 gram per deciliter (g/dL), Platelet count <75,000 per millimeter cube (/mm^³), White blood cell count <1,000/mm^³, Absolute neutrophil count <1,000/mm^³

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Regimen A (Placebo)
Participants of part 1 and part 2 will receive a single loading dose (LD) (Dose 1) followed by 9 maintenance doses (MDs) (Doses 2 to 10) of matching placebo, administered twice daily.
Drug: Placebo
Oral administration of matching placebo.
Experimental: Regimen B (low-dose lumicitabine)
Participants of part 1 and part 2 will receive a single 750 mg LD (Dose 1) followed by nine 250 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.
Drug: lumicitabine
Oral administration of lumicitabine as tablet.
Other Names:
  • ALS-8176/JNJ-64041575
Experimental: Regimen C (High-dose lumicitabine)
Participants of part 2 will receive a single 1000 mg LD (Dose 1) followed by nine 500 mg MDs (Doses 2 to 10) of lumicitabine, administered twice daily.
Drug: lumicitabine
Oral administration of lumicitabine as tablet.
Other Names:
  • ALS-8176/JNJ-64041575

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1
Time Frame: Day 1
Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 1
Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5
Time Frame: Day 5
Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 5
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1
Time Frame: Day 1
AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 1
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5
Time Frame: Day 5
AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 5
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1
Time Frame: Day 1
Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 1
Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5
Time Frame: Day 5
Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.
Day 5
Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7])
Time Frame: Day 1 (Baseline) to 7
RSV RNA viral load in log10 copies/milliliter/day (log10 copies/mL/day) was measured in mid-turbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Due to early termination of study, the analysis was not conducted as planned. Instead, using the same specification as for the primary analysis, a comparison was made on the AUC(1-7) days of pooled active treatment groups versus pooled placebo. The comparison was done as planned using a mixed model for repeated measures, using all available viral load data of baseline up to and including Day 7. The model computes the AUC at group level based on all available data, taking missing data into account under the missing at random assumption. The table reports the planned difference versus (pooled) placebo. No adjustment for multiplicity was applied.
Day 1 (Baseline) to 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 28 Days
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Up to 28 Days
Number of Participants With Vital Sign Abnormalities
Time Frame: Up to 28 Days
Number of participants with vital sign (systolic and diastolic blood pressure [BP], pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported. For systolic BP: abnormally low refers to less than or equal to (<=) 90 millimeter of mercury (mmHg); for diastolic BP: abnormally low refers to <= 50 mmHg; for pulse rate abnormally low refers to less than (<) 45 beats per minutes (bpm) and abnormally high refers to greater than or equal to (>=) 120 bpm; for temperature in degree Celsius abnormally high refers to greater than (>) 37.8 (tympanic), >38.0 (forehead), >38.0 (oral), >37.2 (rectal), >38.0 (axillary); for oxygen saturation in percentage (%) abnormally low refers to < 95. Grade 1 = mild; grade 2 = moderate; grade 3 = severe.
Up to 28 Days
Number of Participants With QT Interval Abnormalities
Time Frame: Up to 28 Days
Number of participants with QT interval abnormalities (prolonged) were reported.
Up to 28 Days
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Up to 28 Days
Number of participants with clinical laboratory (serum chemistry and hematology) abnormalities were reported. Abbreviations; Erythrocyte MCHC = Erythrocyte Mean Corpuscular Hemoglobin Concentration; Erythrocyte MCH = Erythrocyte Mean Corpuscular Hemoglobin; Ery. = Erythrocyte
Up to 28 Days
Time of Hospital Stay From Study Treatment Initiation to Discharge
Time Frame: From study treatment initiation to discharge (Up to 28 Days)
It is the time from treatment initiation to hospital discharge in hours.
From study treatment initiation to discharge (Up to 28 Days)
Time of Hospital Stay From Admission to Discharge
Time Frame: From admission to discharge (Up to 28 Days)
It is the time from hospital admission to hospital discharge in hours.
From admission to discharge (Up to 28 Days)
Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge
Time Frame: From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged
It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator.
From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged
Time of Hospital Stay From Admission to Readiness for Discharge
Time Frame: Up to 28 Days
It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator.
Up to 28 Days
Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment
Time Frame: Up to 28 Days
Number of participants who required to be admitted to the ICU since initiation of treatment were reported.
Up to 28 Days
Duration of Intensive Care Unit Stay
Time Frame: Up to 28 Days
In the event that a participant required ICU since initiation of treatment, the duration for how long the participant remained in the ICU was measured.
Up to 28 Days
Number of Participants Who Required Supplemental Oxygen
Time Frame: Up to 28 Days
Number of participants who required supplemental oxygen were reported.
Up to 28 Days
Time to End of Oxygen Supplementation
Time Frame: Up to 28 Days
It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours.
Up to 28 Days
Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms
Time Frame: Up to 28 Days
Time (number of hours) until SpO2 >= 93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
Up to 28 Days
Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate
Time Frame: Up to 28 Days
It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
Up to 28 Days
Time to Return to Pre-RSV Disease Level for Oxygen Saturation
Time Frame: Up to 28 Days
It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
Up to 28 Days
Time to Return to Pre-RSV Disease Level for Body Temperature
Time Frame: Up to 28 Days
It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.
Up to 28 Days
Number of Participants Who Required Noninvasive Mechanical Ventilation Support
Time Frame: Up to 28 Days
Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported.
Up to 28 Days
Time to End of Noninvasive Mechanical Ventilation Support
Time Frame: Up to 28 Days
It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours.
Up to 28 Days
Number of Participants Who Required Invasive Mechanical Ventilation Support
Time Frame: Up to 28 Days
Number of participants who required invasive mechanical ventilation support were reported.
Up to 28 Days
Time to End of Invasive Mechanical Ventilation Support
Time Frame: Up to 28 Days
It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours.
Up to 28 Days
Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score
Time Frame: Up to 28 Days
It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is the total points on the KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding the scores for all 6 activities which ranges from 0 high (participant independent) to 6 low (participant very dependent). If one or more component was missing, then the KATZ ADL score was not calculated. The return to pre-RSV functional status occurs at the timepoint where for the first time the KATZ ADL score is equal or higher than the pre-RSV KATZ ADL score and after which no scores lower than the pre-RSV KATZ ADL score occur anymore.
Up to 28 Days
Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
Time Frame: Up to 28 Days
Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported.
Up to 28 Days
Time to Clinical Stability
Time Frame: Up to 28 Days
Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate.
Up to 28 Days
Number of Participants in Each Ordinal Scale Category
Time Frame: Day 5/6 (Day of last study treatment)
Number of participants in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities.
Day 5/6 (Day of last study treatment)
Number of Participants With All-Cause Mortality
Time Frame: Up to 28 Days
All-cause mortality included all deaths of participants due to any cause.
Up to 28 Days
RSV RNA Viral Load Over Time
Time Frame: Days 2, 3, 4, 5, 6, 7, 10, 14, and 28
Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated participants) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory.
Days 2, 3, 4, 5, 6, 7, 10, 14, and 28
Peak Viral Load
Time Frame: Up to 28 Days
Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR.
Up to 28 Days
Time to Peak Viral Load
Time Frame: Up to 28 Days
Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.
Up to 28 Days
Rate of Decline of Viral Load
Time Frame: Up to 28 Days
Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (-) log viral load at baseline divided by (/) date/time of 24-hour viral load sample - date/time of baseline viral load.
Up to 28 Days
Time to RSV RNA Viral Load Being Undetectable
Time Frame: Up to 28 Days
It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR.
Up to 28 Days
Number of Participants With Undetectable Viral Load
Time Frame: Up to 28 Days
Number of participants with undetectable viral load up to 28 days were reported.
Up to 28 Days
RSV RNA Viral Load AUC up to Day 14
Time Frame: Up to Day 14
RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.
Up to Day 14
RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration
Time Frame: Up to 1 Day after the last dose of study drug
RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.
Up to 1 Day after the last dose of study drug
Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Time Frame: Baseline up to 28 Days
Number of participants with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported.
Baseline up to 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108217
  • 2016-001653-40 (EudraCT Number)
  • 64041575RSV2003 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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