A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03333317
• Collaborator: (none)
• Enrollment: 7
• Locations: 29
• Arms: 3
• Actual Duration (Months): 3.9
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Viruses	Drug: Lumicitabine; Drug: Placebo	Phase 2

Detailed Description

RSV is a leading cause of lower respiratory tract disease in infants. Most infants and children who get RSV recover fully after 1-2 weeks, but RSV infection can sometimes worsen and may lead to hospitalization and admission into an intensive care unit. The main purpose of this study is to learn how well the study drug (lumicitabine, also known as JNJ-64041575 or ALS-008176) works, how the human body handles the study drug, which dose of the study drug is effective for treatment of RSV infection in infants/children and how safe it is compared to a placebo (placebo looks just like lumicitabine [given in same way] but has no effect against RSV). Approximately up to 180 participants aged between 28 days to 36 months and hospitalized with RSV infection will take part in this world-wide study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus
• Actual Study Start Date: Nov 24, 2017
• Actual Primary Completion Date: Mar 23, 2018
• Actual Study Completion Date: Mar 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A (Low-Dose Lumicitabine) Participants will receive a single 40 milligram per kilogram (mg/kg) loading dose (LD) (Dose 1) followed by nine 20 mg/kg maintenance doses (MDs) (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.	Drug: Lumicitabine; Participants will receive oral administration of lumicitabine.; Other Names: ALS-008176 JNJ-64041575
Experimental: Regimen B (High-Dose Lumicitabine) Participants will receive a single 60 mg/kg LD (Dose 1) followed by nine 40 mg/kg MDs (Doses 2 to 10) of lumicitabine twice daily up to Day 5/6.	Drug: Lumicitabine; Participants will receive oral administration of lumicitabine.; Other Names: ALS-008176 JNJ-64041575
Placebo Comparator: Regimen C (Placebo) Participants will receive either a single 40 mg/kg placebo LD (Dose 1) followed by nine 20 mg/kg maintenance dose (MDs) (Doses 2 to 10) of placebo twice daily or single 60 mg/kg placebo LD (Dose 1) followed by nine 40 mg/kg placebo MDs (Doses 2 to 10), twice daily up to Day 5/6.	Drug: Placebo; Participants will receive oral administration of matching placebo.

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load [Day 1 to 7: Predose, 0.25 and 2 hours postdose]

   AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.

Secondary Outcome Measures

1. Number of Participants With Emergent Adverse Event [Up to 28 days]

   An adverse event (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. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.

2. Number of Participants With Clinically Significant Physical Examinations Abnormalities [Up to 28 days]

   The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported.

3. Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities [Up to 28 days]

   The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.

4. Number of Participants With Electrocardiogram (ECG) Abnormalities [Up to 28 days]

   The number of participants with ECG (QT, and QTc intervals) abnormalities reported.

5. Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades) [Up to 28 days]

   Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.

6. Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine) [Day 1 and Day 5]

   Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).

7. Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine) [Day 1 and Day 5]

   AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).

8. Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine) [Day 1 and Day 5]

   C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine).

9. Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h) [12 hours postdose]

   C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.

10. Length of Hospital Stay [Up to 28 days]

    Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.

11. Number of Participants Admitted to the Intensive Care Unit (ICU) [Up to 28 days]

    Number of participants who were admitted to the ICU was reported.

12. Duration of ICU Stay [Up to 28 days]

    In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.

13. Number of Participants Who Required Supplemental Oxygen [Up to 28 days]

    The number of participants who required supplemental oxygen above pre-RSV infection status was reported.

14. Number of Participants Who Required Non-invasive Mechanical Ventilation Support [Up to 28 days]

    The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.

15. Number of Participants Who Required Invasive Mechanical Ventilation Support [Up to 28 days]

    The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.

16. Duration of Supplemental Oxygen [Up to 28 days]

    Duration of supplemental oxygen above pre-RSV infection status was assessed.

17. Duration of Non-invasive Mechanical Ventilation Support [Up to 28 days]

    Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.

18. Duration of Invasive Mechanical Ventilation Support [Up to 28 days]

    Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.

19. Time to no Longer Requiring Supplemental Oxygen [Up to 28 days]

    Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.

20. Time to Clinical Stability [Up to 28 days]

    Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.

21. Time From Initiation of Study Treatment 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 Onset of Respiratory Symptoms [Up to 28 days]

    Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.

22. Time for Respiratory Rate to Return to Pre-RSV Infection Status [Up to 28 days]

    Time for the respiratory rate to return to pre-RSV infection status was measured.

23. Time for SpO2 to Return to Pre-RSV Infection Status [Up to 28 days]

    Time for SpO2 to return to pre-RSV infection status was measured.

24. Time for Body Temperature to Return To Pre-RSV Infection Status [Up to 28 days]

    Time for body temperature to return to pre-RSV infection status was measured.

25. Number of Participants With Acute Otitis Media [Up to 28 days]

    Number of participants with acute otitis media was reported.

26. Duration of Signs and Symptoms of RSV Infection [Up to 28 days]

    Duration of signs and symptoms of RSV infection was assessed.

27. Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) [Up to 28 days]

    The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).

28. RSV Viral Load Over Time [On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28]

    RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.

29. Peak Viral Load [Up to 28 days]

    Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.

30. Time To Peak Viral Load [Up to 28 days]

    Time to peak viral load was reported.

31. Percentage of Participants With Decline of Viral Load [Up to 28 days]

    Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.

32. Time to RSV Ribonucleic Acid (RNA) Being Undetectable [Up to 28 days]

    Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.

33. Percentage of Participants With Undetectable RSV Viral Load [Up to 28 days]

    Percentage of participants with the undetectable viral load was reported.

34. AUC of RSV RNA Viral Load From Baseline up to Day 10 [Baseline up to Day 10]

    AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.

35. AUC of RSV RNA Viral Load From Baseline up to Day 14 [Baseline up to Day 14]

    AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.

36. AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug [Baseline Until 1 Day after the last dose of study drug (up to 10 days)]

    AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.

37. Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences [Baseline up to 28 days]

    Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.

38. Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA) [Up to Day 6]

    Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Days to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants hospitalized (or in emergency room [ER]) at the time of randomization and unlikely to be discharged for the first 24 hours after randomization

• Participants diagnosed with respiratory syncytial virus (RSV) infection using a polymerase chain reaction (PCR)-based molecular diagnostic assay, with or without co-infection with another respiratory pathogen (respiratory virus or bacteria)

• Participants who have an acute respiratory illness with signs and symptoms consistent with a viral infection (for example, fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset less than or equal to <=5 days from the anticipated time of randomization. Onset of symptoms is defined as the first time (within 1 hour) the parent(s)/caregiver(s) becomes aware of respiratory or systemic symptoms of RSV infection

• With the exception of the symptoms related to the RSV infection or defined comorbid condition for severe RSV disease (prematurity at birth [participant's gestational age was less than {<}37 weeks; for infants <1 year old at randomization], bronchopulmonary dysplasia, congenital heart disease, other congenital diseases, Down syndrome, neuromuscular impairment, or cystic fibrosis), participant must be medically stable on the basis of physical examination, medical history, vital signs/peripheral capillary oxygen saturation (SpO2), and electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying condition in the study population and/or the RSV infection. This determination must be recorded in the participant's source documents and initialed by the investigator. Participants with comorbidities will be allowed to be enrolled once the Independent Data Monitoring Committee (IDMC) has reviewed the pharmacokinetic (PK) and safety data of the highest dose that will be used in this study and once the IDMC has recommended opening recruitment to this group. Sites will be notified when the restriction is lifted

• The participant's estimated glomerular filtration rate (eGFR) is not below the lower limit of normal for the participant's age

Exclusion Criteria:

• Participants who are not expected to survive for more than 48 hours

• Participants who have had major thoracic or abdominal surgery in the 6 weeks prior to randomization

• Participants who have a known or suspected immunodeficiency (except immunoglobulin A [IgA] deficiency), such as a known human immunodeficiency virus infection

• Participants being treated with extracorporeal membrane oxygenation

• Participant receiving chronic oxygen therapy at home prior to admission

• Participants who have a poorly functioning gastrointestinal tract (that is, unable to absorb drugs or nutrition via enteral route)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MemorialCare Research Miller Children's and Women's Hospital Long Beach	Long Beach	California	United States	90806
2	The Children's Mercy Hospital	Kansas City	Missouri	United States	64108
3	Jacobi Medical Center	Bronx	New York	United States	10461
4	SUNY Upstate Medical University	Syracuse	New York	United States	13210
5	West Virginia University	Morgantown	West Virginia	United States	26506
6	American Family Children's Hospital	Madison	Wisconsin	United States	53792
7	Huderf	Bruxelles		Belgium	1020
8	McMaster Children's Hospital	Hamilton	Ontario	Canada	L85 4K1
9	Heim Pal Gyermekkorhaz, Borgyogyaszati Osztaly	Budapest		Hungary	1089
10	Velkey László Gyermekegészségügyi Központ	Miskolc		Hungary	3501
11	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz	Nyíregyháza		Hungary	4400
12	National Hospital Organization Fukuoka Hospital	Fukuoka-shi		Japan	811-1394
13	Fukuoka Children's Hospital	Fukuoka		Japan	813-0017
14	National Hospital Organization Fukuyama Medical Center	Fukuyama		Japan	720-8520
15	Fukuyama City Hospital	Fukuyama		Japan	721-8511
16	JA Hiroshima General Hospital	Hatsukaichi		Japan	738-8503
17	Hirosaki National Hospital	Hirosaki		Japan	036-8545
18	National Hospital Organization Kanazawa Medical Center	Kanazawa		Japan	920-8650
19	National Hospital Organization Kokura Medical Center	Kitakyushu		Japan	802-8533
20	National Hospital Organization Niigata National Hospital	Niigata		Japan	945-8585
21	NHO Beppu Medical Center	Oita		Japan	874-0011
22	Nakano Children's Hospital	Osaka		Japan	535-0022
23	Takatsuki General Hospital	Osaka		Japan	569-1192
24	Ota Memorial Hospital	Ota		Japan	373-8585
25	NHO Saitama National Hospital	Saitama		Japan	351-0102
26	Gunma Children's Medical Center	Shibukawa		Japan	377-8577
27	Shikoku Medical Center for Children and Adults	Zentsuji		Japan	765-8507
28	Plejady Medical Center	Malopolska		Poland	30-349
29	Specialistic Hospital Center for Mother and Child	Poznań		Poland	60-595

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

• Study Protocol - Aug 21, 2017
• Statistical Analysis Plan - Dec 11, 2017

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03333317
• Other Study ID Numbers: CR108367; 2017-001862-56; 64041575RSV2004
• First Posted: Nov 6, 2017
• Last Update Posted: Dec 23, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Virus Diseases

Study Results

Participant Flow

Recruitment Details	On 17 October 2018, the study was stopped prematurely by the sponsor as a precautionary measure, to allow further evaluation and assessment of the new nonclinical pharmacokinetics (PK) and safety findings and determine their relevance to human studies.
Pre-assignment Detail	Total 7 participants were randomized to receive lumicitabine or placebo.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Period Title: Overall Study
STARTED	3	1	3
COMPLETED	3	1	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD	Total
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.	Total of all reporting groups
Overall Participants	3	1	3	7
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	16 (13.08)	17	6.3 (2.52)	12 (9.35)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	1 33.3%	1 14.3%
Male	3 100%	1 100%	2 66.7%	6 85.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	3 100%	1 100%	3 100%	7 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	3 100%	1 100%	3 100%	7 100%
Region of Enrollment (Count of Participants)
JAPAN	3 100%	1 100%	3 100%	7 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load
Description	AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.
Time Frame	Day 1 to 7: Predose, 0.25 and 2 hours postdose

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

2. Secondary Outcome

Title	Number of Participants With Emergent Adverse Event
Description	An adverse event (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. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	3 100%	1 100%	3 100%

3. Secondary Outcome

Title	Number of Participants With Clinically Significant Physical Examinations Abnormalities
Description	The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	2 66.7%	1 100%	1 33.3%

4. Secondary Outcome

Title	Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities
Description	The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Systolic Blood Pressure (Abnormally high)	2 66.7%	1 100%	1 33.3%
Diastolic Blood Pressure (Abnormally high)	1 33.3%	1 100%	0 0%
Pulse Rate (Abnormally high)	1 33.3%	1 100%	1 33.3%
Respiratory Rate (Abnormally high)	0 0%	0 0%	1 33.3%
Temperature (High)	1 33.3%	0 0%	1 33.3%
Oxygen Saturation (Abnormally low)	1 33.3%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities
Description	The number of participants with ECG (QT, and QTc intervals) abnormalities reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
QT Duration	1 33.3%	0 0%	0 0%
QTcB: Bazett's Correction Formula	0 0%	0 0%	0 0%
QTcF: Fridericia's Correction Formula	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)
Description	Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Alanine transaminase (ALT): Grade 0	3 100%	0 0%	3 100%
ALT: Grade 1	0 0%	1 100%	0 0%
Aspartate Aminotransferase (AST): Grade 0	3 100%	1 100%	3 100%
Bilirubin: Grade 0	3 100%	1 100%	3 100%
Creatinine: Grade 0	3 100%	1 100%	2 66.7%
Creatinine: Grade 2	0 0%	0 0%	1 33.3%
Hypoglycemia: Grade 0	3 100%	1 100%	3 100%
Hyperglycemia: Grade 0	3 100%	1 100%	3 100%
Hypokalemia: Grade 0	3 100%	1 100%	3 100%
Hyperkalemia: Grade 0	1 33.3%	1 100%	1 33.3%
Hyperkalemia: Grade 1	2 66.7%	0 0%	2 66.7%
Hyponatremia: Grade 0	3 100%	1 100%	3 100%
Hypernatremia: Grade 0	3 100%	1 100%	3 100%
Hemoglobin (Hb): Grade 0	2 66.7%	1 100%	2 66.7%
Hb: Grade 1	1 33.3%	0 0%	0 0%
Hb: Grade 2	0 0%	0 0%	1 33.3%
Absolute neutrophil count (ANC): Grade 0	2 66.7%	1 100%	0 0%
ANC: Grade 1	1 33.3%	0 0%	1 33.3%
ANC: Grade 3	0 0%	0 0%	1 33.3%
ANC: Grade 4	0 0%	0 0%	1 33.3%
Platelets: Grade 0	3 100%	1 100%	2 66.7%
Platelets: Grade 3	0 0%	0 0%	1 33.3%

7. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)
Description	Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).
Time Frame	Day 1 and Day 5

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) set was defined as all randomized participants who receive at least 1 dose of study.

Arm/Group Title	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	1	3
Day 1	6184	7003 (3806)
Day 5	3261	5112 (1665)

8. Secondary Outcome

Title	Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)
Description	AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).
Time Frame	Day 1 and Day 5

Outcome Measure Data

Analysis Population Description

ITT set was defined as all randomized participants who receive at least 1 dose of study.

Arm/Group Title	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	1	3
Day 1	12700	17800 (713.9)
Day 5	11840	20500 (655.7)

9. Secondary Outcome

Title	Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)
Description	C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine).
Time Frame	Day 1 and Day 5

Outcome Measure Data

Analysis Population Description

ITT set was defined as all randomized participants who receive at least 1 dose of study.

Arm/Group Title	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	1	3
Day 1	91.16	187.8 (52.97)
Day 5	189.8	358.3 (37.42)

10. Secondary Outcome

Title	Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)
Description	C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.
Time Frame	12 hours postdose

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0

11. Secondary Outcome

Title	Length of Hospital Stay
Description	Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set. As the study was early terminated with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Participant 1	143.5
Participant 2	167.8
Participant 3	179.4
Participant 4	167.8
Participant 5	120
Participant 6	239.5
Participant 7	149.3

12. Secondary Outcome

Title	Number of Participants Admitted to the Intensive Care Unit (ICU)
Description	Number of participants who were admitted to the ICU was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Duration of ICU Stay
Description	In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

No participant was admitted to ICU hence results could not be determined for this outcome measure.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

14. Secondary Outcome

Title	Number of Participants Who Required Supplemental Oxygen
Description	The number of participants who required supplemental oxygen above pre-RSV infection status was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	1 33.3%	1 100%	0 0%

15. Secondary Outcome

Title	Number of Participants Who Required Non-invasive Mechanical Ventilation Support
Description	The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants Who Required Invasive Mechanical Ventilation Support
Description	The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	0 0%

17. Secondary Outcome

Title	Duration of Supplemental Oxygen
Description	Duration of supplemental oxygen above pre-RSV infection status was assessed.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set who received supplemental oxygen.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	1	1	0
Number [Hours]	59.4	0.5

18. Secondary Outcome

Title	Duration of Non-invasive Mechanical Ventilation Support
Description	Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

No participant received non-invasive mechanical ventilation support hence results could not be drawn for this outcome measure.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

19. Secondary Outcome

Title	Duration of Invasive Mechanical Ventilation Support
Description	Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

No participant received invasive mechanical ventilation support hence results could not be drawn for this outcome measure.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

20. Secondary Outcome

Title	Time to no Longer Requiring Supplemental Oxygen
Description	Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set who received supplemental oxygen.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	1	1	0
Number [Hours]	59.4	0.5

21. Secondary Outcome

Title	Time to Clinical Stability
Description	Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set. Due to early study termination and less number of participants collected data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Participant 1	63.8
Participant 2	39.5
Participant 3	191.2
Participant 4	63.3
Participant 5	71.3
Participant 6	646.4
Participant 7	0

22. Secondary Outcome

Title	Time From Initiation of Study Treatment 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 Onset of Respiratory Symptoms
Description	Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

23. Secondary Outcome

Title	Time for Respiratory Rate to Return to Pre-RSV Infection Status
Description	Time for the respiratory rate to return to pre-RSV infection status was measured.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set. As study was terminated early with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Participant 1	0
Participant 2	39.5
Participant 3	46.4
Participant 4	0
Participant 5	71.3
Participant 6	646.4
Participant 7	0

24. Secondary Outcome

Title	Time for SpO2 to Return to Pre-RSV Infection Status
Description	Time for SpO2 to return to pre-RSV infection status was measured.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Participant 1	0
Participant 2	0
Participant 3	70
Participant 4	33.7
Participant 5	0
Participant 6	0
Participant 7	0

25. Secondary Outcome

Title	Time for Body Temperature to Return To Pre-RSV Infection Status
Description	Time for body temperature to return to pre-RSV infection status was measured.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Participant 1	0
Participant 2	643.5
Participant 3	37.4
Participant 4	16.7
Participant 5	0
Participant 6	0
Participant 7	641.6

26. Secondary Outcome

Title	Number of Participants With Acute Otitis Media
Description	Number of participants with acute otitis media was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	0 0%

27. Secondary Outcome

Title	Duration of Signs and Symptoms of RSV Infection
Description	Duration of signs and symptoms of RSV infection was assessed.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

28. Secondary Outcome

Title	Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Description	The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

29. Secondary Outcome

Title	RSV Viral Load Over Time
Description	RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Time Frame	On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28

Outcome Measure Data

Analysis Population Description

Intention-To-Treat-infected (ITT-i) set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Day 2	5.817 (2.2087)	6.809	6.660 (0.9732)
Day 3	5.443 (1.4645)	6.000	5.351 (0.5794)
Day 4	4.674 (2.4209)	2.900	4.190 (1.4190)
Day 5	3.808 (1.0049)	5.949	4.521 (1.7506)
Day 6	3.137 (1.9306)	6.514	4.110 (1.6980)
Day 7	2.994 (1.4450)	4.584	2.754 (1.2688)
Day 10	2.821 (1.5950)	1.900	3.573 (0.7610)
Day 14	1.900 (0.0000)	2.900	1.983 (0.1443)
Day 28	1.900 (0.0000)	1.900	1.900 (0.0000)

30. Secondary Outcome

Title	Peak Viral Load
Description	Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

31. Secondary Outcome

Title	Time To Peak Viral Load
Description	Time to peak viral load was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

32. Secondary Outcome

Title	Percentage of Participants With Decline of Viral Load
Description	Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

ITT-i set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a PCR-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Number [Percentage of participants]	100 3333.3%	100 10000%	100 3333.3%

33. Secondary Outcome

Title	Time to RSV Ribonucleic Acid (RNA) Being Undetectable
Description	Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

34. Secondary Outcome

Title	Percentage of Participants With Undetectable RSV Viral Load
Description	Percentage of participants with the undetectable viral load was reported.
Time Frame	Up to 28 days

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

35. Secondary Outcome

Title	AUC of RSV RNA Viral Load From Baseline up to Day 10
Description	AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.
Time Frame	Baseline up to Day 10

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

36. Secondary Outcome

Title	AUC of RSV RNA Viral Load From Baseline up to Day 14
Description	AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Time Frame	Baseline up to Day 14

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

37. Secondary Outcome

Title	AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug
Description	AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.
Time Frame	Baseline Until 1 Day after the last dose of study drug (up to 10 days)

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

38. Secondary Outcome

Title	Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences
Description	Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.
Time Frame	Baseline up to 28 days

Outcome Measure Data

Analysis Population Description

Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	3	1	3
Count of Participants [Participants]	0 0%	0 0%	0 0%

39. Secondary Outcome

Title	Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)
Description	Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).
Time Frame	Up to Day 6

Outcome Measure Data

Analysis Population Description

As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.

Arm/Group Title	Placebo	Lumicitabine 40/20 mg/kg LD/MD	Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).	Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.	Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
Measure Participants	0	0	0

Adverse Events

Time Frame	Up to 28 days
Adverse Event Reporting Description	Safety analysis set included all participants who received at least 1 dose of drug.
Arm/Group Title	Placebo		Lumicitabine 40/20 mg/kg LD/MD		Lumicitabine 60/40 mg/kg LD/MD
Arm/Group Description	Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10).		Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day.		Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day.
All Cause Mortality
	Placebo		Lumicitabine 40/20 mg/kg LD/MD		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)		0/3 (0%)
Serious Adverse Events
	Placebo		Lumicitabine 40/20 mg/kg LD/MD		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Blood and lymphatic system disorders
Febrile Neutropenia	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Other (Not Including Serious) Adverse Events
	Placebo		Lumicitabine 40/20 mg/kg LD/MD		Lumicitabine 60/40 mg/kg LD/MD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		1/1 (100%)		3/3 (100%)
Blood and lymphatic system disorders
Neutropenia	0/3 (0%)		0/1 (0%)		2/3 (66.7%)
Thrombocytopenia	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Gastrointestinal disorders
Diarrhoea	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Infections and infestations
Bronchitis	0/3 (0%)		1/1 (100%)		0/3 (0%)
Pharyngitis	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Pneumonia Bacterial	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	1/3 (33.3%)		0/1 (0%)		0/3 (0%)
Skin and subcutaneous tissue disorders
Dermatitis Diaper	0/3 (0%)		0/1 (0%)		1/3 (33.3%)
Erythema	1/3 (33.3%)		0/1 (0%)		0/3 (0%)

Limitations/Caveats

Only 7 participants were treated before the study was prematurely terminated. Due to this small number of treated subjects, statistical analysis was not conducted as planned. Hence it was not possible to evaluate the primary or secondary objectives.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.