Trial · NCT02935673
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | Day 1 | Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. |
| Primary | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | Day 5 | Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. |
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 | 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. |
| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 | 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. |
| Primary | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | Day 1 | Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. |
| Primary | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5 | Day 5 | Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. |
| Primary | 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]) | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | 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. |
| Secondary | Number of Participants With Vital Sign Abnormalities | 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. |
| Secondary | Number of Participants With QT Interval Abnormalities | Up to 28 Days | Number of participants with QT interval abnormalities (prolonged) were reported. |
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | 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 |
| Secondary | Time of Hospital Stay From Study Treatment Initiation to Discharge | From study treatment initiation to discharge (Up to 28 Days) | It is the time from treatment initiation to hospital discharge in hours. |
| Secondary | Time of Hospital Stay From Admission to Discharge | From admission to discharge (Up to 28 Days) | It is the time from hospital admission to hospital discharge in hours. |
| Secondary | Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge | 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. |
| Secondary | Time of Hospital Stay From Admission to Readiness for Discharge | 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. |
| Secondary | Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment | Up to 28 Days | Number of participants who required to be admitted to the ICU since initiation of treatment were reported. |
| Secondary | Duration of Intensive Care Unit Stay | 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. |
| Secondary | Number of Participants Who Required Supplemental Oxygen | Up to 28 Days | Number of participants who required supplemental oxygen were reported. |
| Secondary | Time to End of Oxygen Supplementation | 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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