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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03502694
Registration number
NCT03502694
Ethics application status
Date submitted
11/04/2018
Date registered
19/04/2018
Date last updated
15/11/2018
Titles & IDs
Public title
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Oral Lumicitabine Regimens in Hospitalized Adult Participants Infected With Human Metapneumovirus
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Scientific title
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Adult Subjects Infected With Human Metapneumovirus
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Secondary ID [1]
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2017-001696-22
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Secondary ID [2]
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CR108378
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Universal Trial Number (UTN)
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Trial acronym
STEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metapneumovirus
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lumicitabine
Treatment: Drugs - Placebo
Experimental: Regimen A (Low-Dose Lumicitabine) - Participants will receive a single 750 milligram (mg) loading dose (LD) (Dose 1) of lumicitabine and matching placebo followed by nine 250 mg tablets as maintenance doses (MDs) (Doses 2 to 10) of lumicitabine and matching placebo administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).
Experimental: Regimen B (High-Dose Lumicitabine) - Participants will receive a single 1000 mg LD (Dose 1) of lumicitabine followed by nine 500 mg tablets as MDs (Doses 2 to 10) of lumicitabine and matching placebo tablet, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).
Placebo Comparator: Regimen C (Placebo) - Participants will receive a placebo LD (Dose 1) followed by nine MDs (Doses 2 to 10) of matching placebo, administered twice daily during Day 1 to Day 5/6 (depending on the timing of the LD).
Treatment: Drugs: Lumicitabine
Participants will receive loading dose and maintenance dose of lumicitabine tablets orally.
Treatment: Drugs: Placebo
Participants will receive matching placebo tablets orally.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Area Under the Concentration-Time Curve (AUC) of Human Metapneumovirus (hMPV) Viral Load
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Assessment method [1]
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The AUC of hMPV ribonucleic acid (RNA) logarithm base 10 (log10) viral load (measured by quantitative real time reverse transcriptase polymerase chain reaction [qRT-PCR] in the mid-turbinate nasal swab specimens) is estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach.
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Timepoint [1]
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Baseline up to Day 7
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Secondary outcome [1]
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Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Assessment method [1]
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
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Timepoint [1]
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Up to 28 days
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Secondary outcome [2]
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Number of Participants with an Abnormal Physical Examination Findings (Height, Body Weight, Respiratory System, Nose, Ear, Throat, Facial and Neck Lymph Nodes, and Skin Examination) as a Measure of Safety and Tolerability
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Assessment method [2]
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Number of participants with an abnormal physical examination will be reported. A complete physical examination (including all body systems, height [only at screening], and body weight measurement) or a directed physical examination including respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination will be performed.
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Timepoint [2]
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Up to 28 days
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Secondary outcome [3]
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Number of Participants with an Abnormal Vital Signs/Peripheral Capillary Oxygen Saturation (SpO2) Reading as a Measure of Safety and Tolerability
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Assessment method [3]
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Number of participants with abnormal vital signs (including body temperature, heart rate, respiratory rate, systolic blood pressure [SBP], diastolic blood pressure [DBP]), and SpO2 measurements will be reported.
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Timepoint [3]
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Up to 28 days
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Secondary outcome [4]
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Number of Participants with an Abnormal Electrocardiogram (ECG) Reading as a Measure of Safety and Tolerability
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Assessment method [4]
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Number of participants with abnormal twelve-lead ECG will be reported.
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Timepoint [4]
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Up to 28 days
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Secondary outcome [5]
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Number of Participants with Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability
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Assessment method [5]
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Number of participants with clinical laboratory abnormalities (clinical laboratory tests include the following: hematology panel, serum chemistry panel, urinalysis, estimated glomerular filtration rate (GFR), urine pregnancy test (women only), and serum procalcitonin levels) will be reported.
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Timepoint [5]
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Up to 28 days
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Secondary outcome [6]
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Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109
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Assessment method [6]
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The Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolite of lumicitabine.
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Timepoint [6]
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Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose
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Secondary outcome [7]
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Concentration at 12 Hours Postdose (C12h) of JNJ-63549109
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Assessment method [7]
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The C12h is the predicted concentration of JNJ-63549109 at 12 hours postdose.
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Timepoint [7]
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Days 1, 2, and 5/6: 12 hours postdose
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Secondary outcome [8]
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Area Under the Plasma Concentration-Time Curve (AUC) of JNJ-63549109
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Assessment method [8]
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AUC is defined as area under plasma concentration-time curve.
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Timepoint [8]
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Dose 1: 0.5 to 1 hour postdose, and 2 to 3 hours postdose; Dose 2: predose, and 3 to 6 hours postdose; Dose 3 and 10: predose
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Secondary outcome [9]
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Ordinal Scale
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Assessment method [9]
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The ordinal scale will be used to assess participant's status and consists of 6 categories that are exhaustive, mutually exclusive, and ordered, where: 1) Death, 2) Admitted to intensive care unit (ICU), 3) Non-ICU hospitalization requiring supplemental oxygen, 4) Non-ICU hospitalization not requiring supplemental oxygen, 5) Not hospitalized, unable to resume normal activities, 6) Not hospitalized, resumption of normal activities.
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Timepoint [9]
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Day of last dose (Day 5 or Day 6)
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Secondary outcome [10]
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Length of Hospital Stay from Admission to Discharge
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Assessment method [10]
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The length of hospital stay from admission to discharge will be reported.
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Timepoint [10]
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From admission to discharge (Up to 28 days)
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Secondary outcome [11]
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Length of Hospital Stay from Admission to Readiness for Discharge
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Assessment method [11]
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The length of hospital stay from admission to readiness for discharge will be reported.
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Timepoint [11]
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From admission to readiness for discharge discharge (Up to 28 days)
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Secondary outcome [12]
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Length of Hospital Stay from Study Treatment Initiation to Discharge
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Assessment method [12]
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The length of hospital stay from study treatment initiation to discharge will be reported.
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Timepoint [12]
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From study treatment initiation to discharge (Up to 28 days)
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Secondary outcome [13]
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Length of Hospital Stay from Study Treatment Initiation to Readiness for Discharge
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Assessment method [13]
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The length of hospital stay from study treatment initiation to readiness for discharge will be reported.
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Timepoint [13]
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From study treatment initiation to readiness for discharge (Up to 28 days)
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Secondary outcome [14]
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Percentage of Participants Requiring Admission to the Intensive Care Unit (ICU)
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Assessment method [14]
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The percentage of enrolled participants requiring admission to the ICU will be reported.
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Timepoint [14]
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Up to 28 days
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Secondary outcome [15]
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Duration of ICU Stay
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Assessment method [15]
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In the event that a participant requires admission to the ICU, the duration for how long the participant remained in the ICU will be measured.
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Timepoint [15]
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Up to 28 days
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Secondary outcome [16]
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Percentage of Participants Requiring Oxygen Supplementation/Noninvasive Mechanical Ventilation Support
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Assessment method [16]
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The percentage of enrolled participants requiring oxygen supplementation/noninvasive mechanical ventilation support (for example [eg], nasal cannula, face mask, continuous positive airway pressure, bilevel positive airway pressure) above pre-hMPV infection status will be reported.
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Timepoint [16]
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Up to 28 days
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Secondary outcome [17]
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Duration of Oxygen Supplementation/Noninvasive Mechanical Ventilation Support
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Assessment method [17]
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The duration of oxygen supplementation/noninvasive mechanical ventilation support (eg, nasal cannula, face mask, continuous positive airway pressure, bilevel positive airway pressure) above pre-hMPV infection status will be measured.
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Timepoint [17]
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Up to 28 days
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Secondary outcome [18]
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Percentage of Participants Requiring Invasive Mechanical Ventilation Support
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Assessment method [18]
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The percentage of enrolled participants requiring invasive mechanical ventilation support (eg, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-hMPV infection status will be reported.
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Timepoint [18]
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Up to 28 days
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Secondary outcome [19]
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Duration of Invasive Mechanical Ventilation Support
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Assessment method [19]
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The duration of invasive mechanical ventilation support (eg, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-hMPV infection status will be measured.
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Timepoint [19]
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Up to 28 days
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Secondary outcome [20]
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Time to no Longer Requiring Supplemental Oxygen
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Assessment method [20]
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The time to which a participant no longer requires supplemental oxygen will be measured.
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Timepoint [20]
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Up to 28 days
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Secondary outcome [21]
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Time to Clinical Stability
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Assessment method [21]
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Time to clinical stability is defined as the time at which the following criteria are 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.
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Timepoint [21]
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Up to 28 days
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Secondary outcome [22]
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Number of Hours from Initiation of Study Treatment Until SpO2 is Greater Than or equal to (>=) 93 Percent (%) on Room air
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Assessment method [22]
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The number of hours until SpO2 is >= 93% on room air among participants who were not on supplemental oxygen prior to onset of respiratory symptoms will be recorded.
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Timepoint [22]
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Up to 28 days
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Secondary outcome [23]
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Time for Respiratory Rate to Return to Pre-hMPV Infection Status
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Assessment method [23]
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The time for respiratory rate to return to pre-hMPV infection status will be recorded.
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Timepoint [23]
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Up to 28 days
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Secondary outcome [24]
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Time for Peripheral Capillary Oxygen Saturation (SpO2) Return to Pre-hMPV Infection Status
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Assessment method [24]
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The time for SpO2 to return to pre-hMPV infection status will be recorded.
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Timepoint [24]
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Up to 28 days
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Secondary outcome [25]
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Time for Body Temperature to Return to Pre-hMPV Infection Status
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Assessment method [25]
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The time for body temperature to return to pre-hMPV infection status will be recorded.
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Timepoint [25]
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Up to 28 days
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Secondary outcome [26]
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Percentage of Enrolled Participants Who Require Hydration and/or Feeding by Intravenous (IV) Catheter or Nasogastric Tube
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Assessment method [26]
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The percentage of enrolled participants who require hydration and/or feeding by intravenous (IV) catheter or nasogastric tube will be reported.
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Timepoint [26]
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Up to 28 days
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Secondary outcome [27]
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Number of Participants With Bacterial Superinfections Reported as AEs
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Assessment method [27]
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The number of participants with bacterial superinfections, as defined by the investigator based on clinical judgment and/or increasing procalcitonin levels, reported as AEs will be reported.
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Timepoint [27]
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Up to 28 days
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Secondary outcome [28]
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Number of Participants With Treatment-Emergent Complications
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Assessment method [28]
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The number of participants with treatment-emergent complications, including cardiovascular events and cerebrovascular events (for example, myocardial infarction, congestive heart failure exacerbation, arrhythmia, stroke) or Clostridium difficile-associated diarrhea, will be reported.
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Timepoint [28]
0
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Up to 28 days
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Secondary outcome [29]
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Change From Baseline in the National Early Warning Score (NEWS) Over Time
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Assessment method [29]
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The NEWS scoring system measures acute-illness severity using 7 physiological parameters (respiration rate, oxygen saturation, supplementary oxygen requirement, temperature, systolic blood pressure, heart rate, and level of consciousness). Each parameter is scored between 0 and 3 compared to normal ranges, with higher scores indicating greater severity. The total score is the sum of the individual physiological parameter values and ranges between 0 (least severe) and 21 (most severe).
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Timepoint [29]
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Baseline up to 28 days
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Secondary outcome [30]
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Number of Participants With All-Cause Mortality
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Assessment method [30]
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Number of participants will be assessed for all-cause mortality.
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Timepoint [30]
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Up to 28 days
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Secondary outcome [31]
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Time to Return to Pre-hMPV Infection Functional Status (Katz Activities of Daily Living [ADL] score)
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Assessment method [31]
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Katz activities of daily living will assess questions related to Bathing, Dressing, Toileting, Transferring, Continence and Feeding. For the six individual activities, a score of 1 indicates independence, and a score of 0 indicates dependence. Total score will be calculated by adding the scores of all six activities and ranges from 0 high (participant independent) to 6 low (participant very dependent).
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Timepoint [31]
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Up to 28 Days
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Secondary outcome [32]
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hMPV Viral Load Over Time
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Assessment method [32]
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Viral load over time will be 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) by qRT-PCR.
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Timepoint [32]
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Up to 28 days
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Secondary outcome [33]
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Peak hMPV Viral Load
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Assessment method [33]
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Peak viral load over time will be measured by qRT-PCR.
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Timepoint [33]
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Up to 28 days
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Secondary outcome [34]
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Time to Peak hMPV Viral Load
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Assessment method [34]
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Time to peak viral load as measured by qRT-PCR will be reported.
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Timepoint [34]
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Up to 28 days
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Secondary outcome [35]
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Rate of Decline of hMPV Viral Load
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Assessment method [35]
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Rate of decline in hMPV viral load during treatment as measured by qRT-PCR will be reported.
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Timepoint [35]
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Up to 28 days
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Secondary outcome [36]
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Time to hMPV Ribonucleic Acid (RNA) Being Undetectable
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Assessment method [36]
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Time to hMPV RNA being undetectable as measured by qRT-PCR.
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Timepoint [36]
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Up to 28 days
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Secondary outcome [37]
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Percentage of Participants With Undetectable hMPV Viral Load at Each Timepoint
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Assessment method [37]
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Percentage of participants with undetectable viral load at each time point will be reported.
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Timepoint [37]
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From Day 1 to Day 7 and on Day 10, Day 14, and Day 28
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Secondary outcome [38]
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AUC of hMPV Viral Load From Baseline up to Day 10
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Assessment method [38]
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The AUC of hMPV RNA log10 viral load (measured by qRT-PCR in the mid-turbinate nasal swab specimens) is estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach.
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Timepoint [38]
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Baseline up to Day 10
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Secondary outcome [39]
0
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AUC of hMPV Viral Load from Baseline up to Day 14
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Assessment method [39]
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The AUC of hMPV RNA log10 viral load (measured by qRT-PCR in the mid-turbinate nasal swab specimens) is estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach.
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Timepoint [39]
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Baseline up to Day 14
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Secondary outcome [40]
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AUC of hMPV Viral Load in Participants Assigned to a Longer Dosing Duration From Baseline Until 1 day After the Last Dose of Study Drug
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Assessment method [40]
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If dosing duration is increased by the Independent Data Monitoring Committee (IDMC), the AUC of hMPV viral load (measured by qRT-PCR in the mid-turbinate nasal swab specimens) will be estimated by analyzing mean log10 viral load values over time using a restricted maximum likelihood based repeated measures approach.
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Timepoint [40]
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Baseline Until 1 day After the Last Dose of Study Drug (approximately up to 12 days)
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Secondary outcome [41]
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Number of Participants With Postbaseline Changes in the hMPV Polymerase Lgene and Other Regions of the hMPV Genome Compared With Baseline Sequences
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Assessment method [41]
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Number of participants will be assessed for postbaseline changes in the hMPV polymerase Lgene (only if no mutations are seen in the Lgene) and other regions of the hMPV genome compared with baseline sequences.
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Timepoint [41]
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Up to 28 days
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Eligibility
Key inclusion criteria
- Participants 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
- Participants diagnosed with human metapneumovirus (hMPV) infection using a rapid
polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without
coinfection with another respiratory pathogen (respiratory virus or bacteria)
- Participants with an acute respiratory illness with signs and symptoms consistent with
a viral infection (for example, fever, cough, nasal congestion, runny nose, sore
throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or
equal to (<=)5 days from the anticipated time of randomization
- With the exception of the symptoms related to hMPV infection, participants must be
medically stable on the basis of physical examination, medical history, 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 hMPV infection. This determination must be recorded in the
participant's source documents and initialed by the investigator
- A woman must have a negative urine pregnancy test (beta-human chorionic gonadotropin
[b-hCG]) at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 immunocompromised within the
past 12 months, whether due to underlying medical condition (for example, malignancy
or genetic disorder) or medical therapy (for 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 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 a known history of human immunodeficiency virus (HIV) or chronic
viral hepatitis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
5/11/2018
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/10/2020
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [2]
0
0
Flinders Medical Centre - Adelaide
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Recruitment hospital [3]
0
0
Princess Alexandra Hospital - Brisbane
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Recruitment hospital [4]
0
0
Barwon Health - University Hospital Geelong - Geelong
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Recruitment hospital [5]
0
0
Royal Melbourne Hospital - Melbourne
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Recruitment hospital [6]
0
0
Mater Hospital Brisbane - South Brisbane
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Recruitment hospital [7]
0
0
Westmead Hospital - Sydney
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Recruitment postcode(s) [1]
0
0
5011 - Adelaide
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Recruitment postcode(s) [2]
0
0
5042 - Adelaide
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Recruitment postcode(s) [3]
0
0
4102 - Brisbane
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Recruitment postcode(s) [4]
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0
3220 - Geelong
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Recruitment postcode(s) [5]
0
0
3050 - Melbourne
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Recruitment postcode(s) [6]
0
0
4101 - South Brisbane
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Recruitment postcode(s) [7]
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0
2145 - Sydney
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Illinois
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New Jersey
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Wisconsin
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Bahia Blanca
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Bahía Blanca
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Buenos Aires
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Ciudad De Buenos Aires
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Ciudad De La Plata
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Cordoba
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Country [13]
0
0
Argentina
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State/province [13]
0
0
La Plata
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Porto Alegre
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Ribeirao Preto
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Sao Paulo
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Country [17]
0
0
Brazil
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State/province [17]
0
0
São Paulo
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Country [18]
0
0
Bulgaria
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State/province [18]
0
0
Kozloduy
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Country [19]
0
0
Bulgaria
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State/province [19]
0
0
Pernik
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Country [20]
0
0
Bulgaria
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State/province [20]
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0
Troyan
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Country [21]
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0
Bulgaria
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State/province [21]
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Veliko Tarnovo
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Country [22]
0
0
France
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State/province [22]
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Bois Guillaume
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Country [23]
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France
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State/province [23]
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Caen
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Country [24]
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0
France
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Colombes
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France
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State/province [25]
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Créteil
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Country [26]
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France
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State/province [26]
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Dijon
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Country [27]
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0
France
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State/province [27]
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La Tronche
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Country [28]
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0
France
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State/province [28]
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Nîmes
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Country [29]
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0
France
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State/province [29]
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Paris
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Country [30]
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France
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State/province [30]
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Poitiers
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Country [31]
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France
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State/province [31]
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St Priest En Jarez
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Country [32]
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France
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State/province [32]
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Suresnes
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Country [33]
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France
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State/province [33]
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0
Tours Cedex
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Country [34]
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Japan
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State/province [34]
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Fukuoka
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Country [35]
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Japan
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State/province [35]
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Gifu
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Country [36]
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Japan
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State/province [36]
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Hamamatue
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Country [37]
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0
Japan
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State/province [37]
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Isahaya
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Country [38]
0
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Japan
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State/province [38]
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Izumo
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Country [39]
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Japan
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State/province [39]
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Kitakyusyu
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Country [40]
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Japan
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State/province [40]
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Kobe-City
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Country [41]
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Japan
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State/province [41]
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Nagano
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Country [42]
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Japan
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State/province [42]
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Nagasaki
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Country [43]
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Japan
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Nagoya
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Country [44]
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Japan
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Osaka
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Country [45]
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Japan
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Ota
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Country [46]
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Japan
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Sendai
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Country [47]
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Japan
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Shiogama
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Country [48]
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Japan
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State/province [48]
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Tokai-Mura
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Country [49]
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Japan
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State/province [49]
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Tokyo
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Country [50]
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Japan
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Uruma
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Country [51]
0
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Japan
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State/province [51]
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Yamagata
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Country [52]
0
0
Japan
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State/province [52]
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0
Yamaguchi
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Country [53]
0
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Japan
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State/province [53]
0
0
Yukuhashi
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Country [54]
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Korea, Republic of
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State/province [54]
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Bucheon
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Country [55]
0
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Korea, Republic of
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State/province [55]
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Daegu
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Country [56]
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Korea, Republic of
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State/province [56]
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Incheon
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Country [57]
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Korea, Republic of
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State/province [57]
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Seongnam
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Country [58]
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Korea, Republic of
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State/province [58]
0
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Seoul
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Country [59]
0
0
Malaysia
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State/province [59]
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Alor Setar
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Country [60]
0
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Malaysia
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State/province [60]
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George Town
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Country [61]
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Malaysia
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State/province [61]
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Kota Bharu
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Country [62]
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Malaysia
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State/province [62]
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Kuala Lumpur
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Country [63]
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Malaysia
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State/province [63]
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Kuching
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Country [64]
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Malaysia
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State/province [64]
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Miri
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Country [65]
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Malaysia
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State/province [65]
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Taiping
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Country [66]
0
0
Netherlands
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State/province [66]
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Groningen
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Country [67]
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Netherlands
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State/province [67]
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Utrecht
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Country [68]
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Netherlands
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State/province [68]
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0
Zutphen
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Country [69]
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Poland
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State/province [69]
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Bydgoszcz
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Country [70]
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Poland
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State/province [70]
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Checiny
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Country [71]
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Poland
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State/province [71]
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Mrozy
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Country [72]
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Poland
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State/province [72]
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Olsztyn
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Country [73]
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Poland
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State/province [73]
0
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Proszowice
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Country [74]
0
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Russian Federation
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State/province [74]
0
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Engels
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Country [75]
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Russian Federation
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State/province [75]
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Smolensk
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Country [76]
0
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Russian Federation
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State/province [76]
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St. Petersburg
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Country [77]
0
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Russian Federation
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State/province [77]
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Tomsk
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Country [78]
0
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Russian Federation
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State/province [78]
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Voronezh
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Country [79]
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Russian Federation
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State/province [79]
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Yaroslavl
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Country [80]
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0
Spain
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State/province [80]
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Elche
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Country [81]
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Spain
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State/province [81]
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Madrid
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Country [82]
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Spain
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State/province [82]
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Santiago De Compostela
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Country [83]
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Spain
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State/province [83]
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Vigo
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Country [84]
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Sweden
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State/province [84]
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Göteborg
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Country [85]
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Sweden
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State/province [85]
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Malmö
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Country [86]
0
0
Sweden
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State/province [86]
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0
Umeå
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Country [87]
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Sweden
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State/province [87]
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Uppsala
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Country [88]
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0
Taiwan
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State/province [88]
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0
Kaohsiung
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Country [89]
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Taiwan
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State/province [89]
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New Taipei
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Country [90]
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Taiwan
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State/province [90]
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Taichung
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Country [91]
0
0
Taiwan
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State/province [91]
0
0
Taipei
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Country [92]
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0
Ukraine
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State/province [92]
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0
Chernivtsi
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Country [93]
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Ukraine
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State/province [93]
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Ivano-Frankivsk
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Country [94]
0
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Ukraine
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State/province [94]
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Kharkiv
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Country [95]
0
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Ukraine
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State/province [95]
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine in hospitalized adult participants infected with
human metapneumovirus (hMPV - a virus closely related to respiratory syncytial virus (RSV)
and has been identified as an important cause of acute respiratory infections, affecting all
age groups) the dose-response relationship of multiple regimens of lumicitabine on antiviral
activity based on nasal hMPV shedding using quantitative reverse transcriptase-polymerase
chain reaction (qRT-PCR) assay.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03502694
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03502694
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