| Primary | Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 | Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs. | The intent-to-treat-infected (ITT-i) population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies*hr/mL | | Baseline through Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000207.3± 89.55
- OG001246.3± 67.39
- OG002203.4± 87.63
|
|
| |
| Primary | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies*hr/mL | | Baseline through Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies*hr/mL | | Baseline through Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 | Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies*hr/mL | | Baseline through Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Change From Baseline in RSV Viral Load at Day 3 | Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline to Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Change From Baseline in RSV Viral Load at Day 5 | Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline to Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Change From Baseline in RSV Viral Load at Day 8 | Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline to Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Change From Baseline in RSV Viral Load at Day 14 | Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Change From Baseline in RSV Viral Load at Day 21 | Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Baseline | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Day 3 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Day 5 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Day 8 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Day 14 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | RSV Viral Load at Day 21 | RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Log10 copies/mL | | Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Time to Undetectable RSV Viral Load | The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. | Posted | | Median | 90% Confidence Interval | Days | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Percentage of Participants With Undetectable RSV Viral Load at Day 3 | Percentage of participants with undetectable RSV viral load at Day 3 were reported. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 3 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Percentage of Participants With Undetectable RSV Viral Load at Day 5 | Percentage of participants with undetectable RSV viral load at Day 5 were reported. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Percentage of Participants With Undetectable RSV Viral Load at Day 8 | Percentage of participants with undetectable RSV viral load at Day 8 were reported. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 8 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Percentage of Participants With Undetectable RSV Viral Load at Day 14 | Percentage of participants with undetectable RSV viral load at Day 14 were reported. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Primary | Percentage of Participants With Undetectable RSV Viral Load at Day 21 | Percentage of participants with undetectable RSV viral load at Day 21 were reported. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of participants | | Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | 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. | The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities | Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable). | The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were valuable for this outcome measure. Here, "n (number analysed)" is defined as number of participants analyzed for specified category. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | |
|
| Secondary | Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities | Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure [SBP] and diastolic blood pressure [DBP]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - < 100 mmHg, Grade 2 (moderate)- greater than or equal to (>=)100 mmHg to < 110 mmHg, Grade 3 (severe)- >=110 mmHg; DBP: Abnormally low- <=90 mmHg, Grade 1 (mild)- 140 mmHg - < 160 mmHg, Grade 2 (moderate)- >=160 mmHg to < 180 mmHg, Grade 3 (severe)- >=180 mmHg. | The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | |
|
| Secondary | Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities | The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]). | The safety analysis set included all participants who received at least 1 dose of study agent, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed for specified categories. | Posted | | Count of Participants | | Participants | | Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
|
| Secondary | Peripheral Capillary Oxygen Saturation (SpO2) Over Time | Peripheral capillary oxygen saturation was measured by the investigator over time. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of SpO2 (%) | | Baseline, Days 3, 8, 14, and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Change From Baseline in Peripheral Capillary Oxygen Saturation | Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | % of SpO2 | | Baseline to Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Pulse Rate Over Time | Pulse rate was measured by the investigator over time. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | | Mean | Standard Deviation | Beats/min | | Baseline, Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Change From Baseline in Pulse Rate | Change from baseline in pulse rate was calculated and reported by the investigator. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Beats/min | | Baseline to Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Respiratory Rate Over Time | Respiratory rate was measured by the investigator over time. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Breaths/min | | Baseline, Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Change From Baseline in Respiratory Rate | Change from baseline in respiratory rate was calculated and reported by the investigator. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Breaths/min | | Baseline to Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Body Temperature Over Time | Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. | Posted | | Mean | Standard Deviation | degree Celsius | | Baseline, Days 3, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Change From Baseline in Body Temperature | Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | degree Celsius | | Baseline to Days 3, 5, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
|
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose | AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose. | Pharmacokinetic (PK) analysis set included all participants who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanograms*hours per milliliter (ng*h/mL) | | 0 to 24 hours post dose on Days 1 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
| |
| Secondary | Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire | The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints for specified categories. | Posted | | Mean | Standard Deviation | Scale on a score | | Baseline, Days 3, 5, 8, 14 and 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
|
| Secondary | Duration of Signs and Symptoms of RSV Assessed by RI-PRO | Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms). | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Median | 90% Confidence Interval | days | | Baseline up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 |
|
| Secondary | Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire | Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms). | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Median | 90% Confidence Interval | Days | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
|
| Secondary | Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire | Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours. | The ITT-i population consisted of all randomized participants who received at least 1 dose of study drug and who had a central lab-confirmed RSV infection. | Posted | | Median | 90% Confidence Interval | days | | Up to Day 21 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. | | OG002 | Treatment C: Placebo | Participants received matching placebo as an oral solution once daily for 7 days. |
| |
| Secondary | Predose Plasma Concentration (Ctrough) of JNJ-53718678 | Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model. | PK analysis set included all participants who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Predose on Days 1 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
| |
| Secondary | Maximum Plasma Concentration (Cmax) of JNJ-53718678 | Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model. | PK analysis set included all participants who received JNJ-53718678 and for whom at least one PK concentration was reported. Here, 'n' (number analyzed) signifies number of participants who were analyzed at specified timepoints. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Days 1 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: JNJ-53718678 500 mg | Participants received JNJ-53718678 500 milligrams (mg) as an oral solution once daily for 7 days. | | OG001 | Treatment B: JNJ-53718678 80 mg + Placebo | Participants received JNJ-53718678 80 mg as an oral solution once daily for 7 days. In addition, participants received matching placebo to maintain the blinding. |
| |