| Primary | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. | Pharmacokinetic (PK) analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001845± 545.2
- OG0012801± 1509
|
|
| |
| Primary | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | ng/mL | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| 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 | 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. | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/mL) | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| 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 | 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. | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | ng*h/mL | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| Primary | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| Primary | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5 | Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine. | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | ng/mL | | Day 5 | | | | ID | Title | Description |
|---|
| OG000 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| 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]) | 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. | Intent-to-treat-infected (ITT-i) set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Least Squares Mean | 95% Confidence Interval | log10 copies/mL/day | | Day 1 (Baseline) to 7 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Number of Participants With Adverse Events (AEs) | 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. | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Number of Participants With Vital Sign Abnormalities | 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. | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine |
|
| Secondary | Number of Participants With QT Interval Abnormalities | Number of participants with QT interval abnormalities (prolonged) were reported. | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Number of Participants With Clinical Laboratory Abnormalities | 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 | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine |
|
| Secondary | Time of Hospital Stay From Study Treatment Initiation to Discharge | It is the time from treatment initiation to hospital discharge in hours. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | From study treatment initiation to discharge (Up to 28 Days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Time of Hospital Stay From Admission to Discharge | It is the time from hospital admission to hospital discharge in hours. | Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | From admission to discharge (Up to 28 Days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge | It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine |
|
| Secondary | Time of Hospital Stay From Admission to Readiness for Discharge | It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator. | Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment | Number of participants who required to be admitted to the ICU since initiation of treatment were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | |
|
| Secondary | Duration of Intensive Care Unit Stay | 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. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is 0, since none of the participants were admitted to ICU since initiation of treatment. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | |
|
| Secondary | Number of Participants Who Required Supplemental Oxygen | Number of participants who required supplemental oxygen were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Time to End of Oxygen Supplementation | It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours. | Population included ITT-i set who required supplemental oxygen. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| 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 | 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. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate | It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | |
|
| Secondary | Time to Return to Pre-RSV Disease Level for Oxygen Saturation | It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 |
|
| Secondary | Time to Return to Pre-RSV Disease Level for Body Temperature | It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
|
| Secondary | Number of Participants Who Required Noninvasive Mechanical Ventilation Support | Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | |
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| Secondary | Time to End of Noninvasive Mechanical Ventilation Support | It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours. | Population included ITT-i set who required noninvasive mechanical ventilation support. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Number of Participants Who Required Invasive Mechanical Ventilation Support | Number of participants who required invasive mechanical ventilation support were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Time to End of Invasive Mechanical Ventilation Support | It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is zero, since none of the participants required mechanical ventilation support. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score | It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is the total points on the KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding the scores for all 6 activities which ranges from 0 high (participant independent) to 6 low (participant very dependent). If one or more component was missing, then the KATZ ADL score was not calculated. The return to pre-RSV functional status occurs at the timepoint where for the first time the KATZ ADL score is equal or higher than the pre-RSV KATZ ADL score and after which no scores lower than the pre-RSV KATZ ADL score occur anymore. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Days | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 |
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| Secondary | Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube | Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | |
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| Secondary | Time to Clinical Stability | Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | Hours | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | |
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| Secondary | Number of Participants in Each Ordinal Scale Category | Number of participants in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Day 5/6 (Day of last study treatment) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Number of Participants With All-Cause Mortality | All-cause mortality included all deaths of participants due to any cause. | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | RSV RNA Viral Load Over Time | Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated participants) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory. | Analysis was performed on ITT-i set. Here 'n' (number analyzed) signifies number of participants evaluable for each time point. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Mean | Standard Deviation | log10 copies/mL | | Days 2, 3, 4, 5, 6, 7, 10, 14, and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine |
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| Secondary | Peak Viral Load | Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Time to Peak Viral Load | Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
| |
| Secondary | Rate of Decline of Viral Load | Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (-) log viral load at baseline divided by (/) date/time of 24-hour viral load sample - date/time of baseline viral load. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Time to RSV RNA Viral Load Being Undetectable | It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | Number of Participants With Undetectable Viral Load | Number of participants with undetectable viral load up to 28 days were reported. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | RSV RNA Viral Load AUC up to Day 14 | RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling. | Data was not collected and analyzed because this study was stopped prematurely. | Posted | | | | | | Up to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | Participants received a single 1000 mg LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 500 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). |
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| Secondary | RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration | RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling. | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. No participant received extended treatment, therefore data was not analyzed. | Posted | | | | | | Up to 1 Day after the last dose of study drug | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine | |
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| Secondary | Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences | Number of participants with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported. | Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Posted | | Count of Participants | | Participants | | Baseline up to 28 Days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single loading dose (LD) (Dose 1) of matching placebo tablet orally on Day 1 followed by nine maintenance doses (MD) (Doses 2 to 10) of matching placebo tablets orally twice daily (bid) from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG001 | 750 mg LD / 250 mg MD Lumicitabine | Participants received a single 750 milligram (mg) LD (Dose 1) of lumicitabine tablet orally followed by nine MD (Doses 2 to 10) of 250 mg lumicitabine tablets orally bid from Day 1/2 to Day 5/6 (depending on the timing of the LD administration). | | OG002 | 1000 mg LD / 500 mg MD Lumicitabine |
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