Trial Outcomes & Findings for A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease (NCT NCT04068792)
NCT ID: NCT04068792
Last Updated: 2025-02-04
Results Overview
RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
COMPLETED
PHASE2
22 participants
Baseline (Day 1) up to Day 5
2025-02-04
Participant Flow
Participant milestones
| Measure |
Placebo
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Two-Part Infant Study for Early Diagnosis of Respiratory Syncytial Virus (RSV) and Evaluation of JNJ-53718678 in RSV Acute Respiratory Tract Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
Total
n=22 Participants
Total of all reporting groups
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|---|---|---|---|
|
Age, Continuous
|
4.10 months
STANDARD_DEVIATION 1.962 • n=99 Participants
|
3.18 months
STANDARD_DEVIATION 1.343 • n=107 Participants
|
3.64 months
STANDARD_DEVIATION 1.707 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Panama
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 5Population: Intent-To-Treat-infected (ITT-i) analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of greater than or equal to (\>=) 1 log10 copies per milliliter (mL) above the lower limit of quantification (LLOQ) of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized.
RSV viral load AUC was determined from immediately prior to first dose of JNJ-53718678 through Day 5. The RSV viral load was measured by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay in mid-turbinate nasal swab specimens.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Respiratory Syncytial Virus (RSV) Viral Load-time Curve From Immediately Prior to First Dose of JNJ-53718678 Through Day 5 (AUC [Day 1-5])
|
26.13 log10 copies*day per milliliter
90% Confidence Interval 23.701 • Interval 23.701 to 28.555
|
25.10 log10 copies*day per milliliter
90% Confidence Interval 22.497 • Interval 22.497 to 27.707
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
RSV viral load actual values over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
RSV Viral Load Over Time
Baseline
|
7.744 log10 copies per milliliter
Standard Deviation 1.1991
|
7.477 log10 copies per milliliter
Standard Deviation 1.4111
|
|
RSV Viral Load Over Time
Day 2
|
7.748 log10 copies per milliliter
Standard Deviation 1.2387
|
6.613 log10 copies per milliliter
Standard Deviation 3.2426
|
|
RSV Viral Load Over Time
Day 5
|
6.105 log10 copies per milliliter
Standard Deviation 1.3664
|
5.287 log10 copies per milliliter
Standard Deviation 2.0195
|
|
RSV Viral Load Over Time
Day 6
|
4.335 log10 copies per milliliter
Standard Deviation 2.3774
|
4.023 log10 copies per milliliter
Standard Deviation 2.8076
|
|
RSV Viral Load Over Time
Day 7
|
4.953 log10 copies per milliliter
Standard Deviation 1.0500
|
3.624 log10 copies per milliliter
Standard Deviation 2.4153
|
|
RSV Viral Load Over Time
Day 8
|
4.020 log10 copies per milliliter
Standard Deviation 0.9431
|
2.924 log10 copies per milliliter
Standard Deviation 2.1366
|
|
RSV Viral Load Over Time
Day 9
|
3.145 log10 copies per milliliter
Standard Deviation 1.8643
|
2.666 log10 copies per milliliter
Standard Deviation 2.1545
|
|
RSV Viral Load Over Time
Day 10
|
2.657 log10 copies per milliliter
Standard Deviation 1.9192
|
3.035 log10 copies per milliliter
Standard Deviation 2.2622
|
|
RSV Viral Load Over Time
Day 11
|
2.598 log10 copies per milliliter
Standard Deviation 1.6655
|
3.059 log10 copies per milliliter
Standard Deviation 2.6895
|
|
RSV Viral Load Over Time
Day 12
|
0.967 log10 copies per milliliter
Standard Deviation 1.6743
|
3.417 log10 copies per milliliter
Standard Deviation 3.4191
|
|
RSV Viral Load Over Time
Day 14
|
2.352 log10 copies per milliliter
Standard Deviation 2.3700
|
2.020 log10 copies per milliliter
Standard Deviation 2.4599
|
|
RSV Viral Load Over Time
Day 21
|
1.837 log10 copies per milliliter
Standard Deviation 1.9135
|
0.883 log10 copies per milliliter
Standard Deviation 1.3426
|
|
RSV Viral Load Over Time
Day 3
|
6.415 log10 copies per milliliter
Standard Deviation 2.3924
|
6.277 log10 copies per milliliter
Standard Deviation 2.8027
|
|
RSV Viral Load Over Time
Day 4
|
5.600 log10 copies per milliliter
Standard Deviation 2.2868
|
5.683 log10 copies per milliliter
Standard Deviation 3.2009
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, and 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>= 1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here, 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
Change from baseline in RSV viral load over time was measured by qRT-PCR in the nasal swab specimens collected at the clinic visits and at home.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Change From Baseline in RSV Viral Load Over Time
Day 2
|
0.022 log10 copies per milliliter
Standard Deviation 0.9247
|
-0.797 log10 copies per milliliter
Standard Deviation 1.8465
|
|
Change From Baseline in RSV Viral Load Over Time
Day 3
|
-1.329 log10 copies per milliliter
Standard Deviation 2.3903
|
-1.293 log10 copies per milliliter
Standard Deviation 1.6220
|
|
Change From Baseline in RSV Viral Load Over Time
Day 4
|
-2.002 log10 copies per milliliter
Standard Deviation 2.7624
|
-1.857 log10 copies per milliliter
Standard Deviation 1.9805
|
|
Change From Baseline in RSV Viral Load Over Time
Day 5
|
-1.638 log10 copies per milliliter
Standard Deviation 1.4728
|
-2.222 log10 copies per milliliter
Standard Deviation 1.4063
|
|
Change From Baseline in RSV Viral Load Over Time
Day 6
|
-3.391 log10 copies per milliliter
Standard Deviation 2.8796
|
-3.153 log10 copies per milliliter
Standard Deviation 1.5444
|
|
Change From Baseline in RSV Viral Load Over Time
Day 7
|
-2.667 log10 copies per milliliter
Standard Deviation 1.8529
|
-3.552 log10 copies per milliliter
Standard Deviation 1.1919
|
|
Change From Baseline in RSV Viral Load Over Time
Day 8
|
-3.630 log10 copies per milliliter
Standard Deviation 1.5622
|
-4.634 log10 copies per milliliter
Standard Deviation 1.6078
|
|
Change From Baseline in RSV Viral Load Over Time
Day 9
|
-5.046 log10 copies per milliliter
Standard Deviation 1.8708
|
-5.564 log10 copies per milliliter
Standard Deviation 2.2160
|
|
Change From Baseline in RSV Viral Load Over Time
Day 10
|
-5.782 log10 copies per milliliter
Standard Deviation 2.3406
|
-5.195 log10 copies per milliliter
Standard Deviation 2.3057
|
|
Change From Baseline in RSV Viral Load Over Time
Day 11
|
-5.580 log10 copies per milliliter
Standard Deviation 1.8008
|
-5.263 log10 copies per milliliter
Standard Deviation 2.7523
|
|
Change From Baseline in RSV Viral Load Over Time
Day 12
|
-7.225 log10 copies per milliliter
Standard Deviation 0.9469
|
-4.905 log10 copies per milliliter
Standard Deviation 3.4450
|
|
Change From Baseline in RSV Viral Load Over Time
Day 14
|
-5.439 log10 copies per milliliter
Standard Deviation 2.0248
|
-5.588 log10 copies per milliliter
Standard Deviation 2.7565
|
|
Change From Baseline in RSV Viral Load Over Time
Day 21
|
-5.907 log10 copies per milliliter
Standard Deviation 1.6829
|
-6.514 log10 copies per milliliter
Standard Deviation 1.5001
|
SECONDARY outcome
Timeframe: Baseline through Days 3, 8, and 14Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints. At Day 14, data was not collected due to low sample size.
RSV viral load AUC was determined by qRT-PCR assay in mid-turbinate nasal swab specimens.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14
Day 8
|
39.20 log10 copies*hour per milliliter (h/mL)
Interval 34.913 to 43.491
|
35.11 log10 copies*hour per milliliter (h/mL)
Interval 31.342 to 38.88
|
|
RSV Viral Load Area Under the Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Days 3, 8, and 14
Day 3
|
14.44 log10 copies*hour per milliliter (h/mL)
Interval 12.841 to 16.042
|
13.70 log10 copies*hour per milliliter (h/mL)
Interval 11.99 to 15.406
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.
Time to undetectable RSV viral load is defined as the time in hours from initiation of study treatment until the first post-baseline time point at which the virus is confirmed undetectable. A confirmed undetectable sample is defined as the first of at least two consecutive samples that are undetectable. The last obtained sample for a participant, if undetectable, is considered confirmed.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Time to Undetectable RSV Viral Load
|
500.1 hours
Interval 239.9 to
'NA' refers that upper limit of confidence interval was not estimable due to low sample size, and censoring.
|
391.4 hours
Interval 185.5 to 526.2
|
SECONDARY outcome
Timeframe: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
Percentage of participants with undetectable RSV viral load at each time point throughout the study were reported.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Baseline
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 2
|
0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 5
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 6
|
20.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 7
|
0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 8
|
0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 9
|
20.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 10
|
25.0 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 11
|
20.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 12
|
66.7 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 21
|
45.5 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 3
|
9.1 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 4
|
11.1 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Undetectable RSV Viral Load at Each Time Point Throughout the Study
Day 14
|
33.3 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 5, 8, 14, and 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
The severity of signs and symptoms of RSV infection (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration) were assessed by the PRESORS. PRESORS is a questionnaire by parent(s)/caregiver(s) recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Baseline
|
0.92 Unit on scale
Standard Deviation 0.345
|
0.56 Unit on scale
Standard Deviation 0.527
|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Day 3
|
0.98 Unit on scale
Standard Deviation 0.535
|
0.60 Unit on scale
Standard Deviation 0.610
|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Day 5
|
0.65 Unit on scale
Standard Deviation 0.456
|
0.37 Unit on scale
Standard Deviation 0.398
|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Day 8
|
0.61 Unit on scale
Standard Deviation 0.461
|
0.23 Unit on scale
Standard Deviation 0.285
|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Day 14
|
0.14 Unit on scale
Standard Deviation 0.323
|
0.08 Unit on scale
Standard Deviation 0.162
|
|
Severity of Signs and Symptoms of RSV Infection Assessed by Parent(s)/Caregiver(s) Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)
Day 21
|
0.15 Unit on scale
Standard Deviation 0.337
|
0.02 Unit on scale
Standard Deviation 0.053
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 5, 8, 14, 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 12-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Outcome measures
| Measure |
Placebo
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=8 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Day 21
|
-0.70 units on scale
Standard Deviation 0.408
|
-0.60 units on scale
Standard Deviation 0.390
|
|
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Day 14
|
-0.73 units on scale
Standard Deviation 0.396
|
-0.54 units on scale
Standard Deviation 0.396
|
|
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Day 3
|
0.01 units on scale
Standard Deviation 0.341
|
-0.02 units on scale
Standard Deviation 0.249
|
|
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Day 5
|
-0.27 units on scale
Standard Deviation 0.309
|
-0.26 units on scale
Standard Deviation 0.437
|
|
Change From Baseline in Parent(s)/Caregiver(s) PRESORS Scores
Day 8
|
-0.42 units on scale
Standard Deviation 0.314
|
-0.39 units on scale
Standard Deviation 0.508
|
SECONDARY outcome
Timeframe: Baseline, Day 3, 5, 8, 14, 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had centrally confirmed RSV viral load of \>=1 log10 copies per mL above LLOQ of RSV RT-qPCR assay at baseline. Analyses on ITT-i set were performed as randomized. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure; 'n' (number analyzed) included all participants who were analyzed at specified timepoints for specific category.
Change from baseline in clinician (for concepts: activity level, sleep disturbance, breathing problems, retractions, tachypnea, feeding problem, cough, nasal secretions, wheezing, dehydration) PRESORS scores was reported. PRESORS is a questionnaire recording presence and severity of signs and symptoms of RSV disease. PRESORS score consisted of 10-items, each item score ranges from 0 to 3. A summary score was derived (mean of the item scores) which also ranges from 0 to 3. The higher the score, the worse the symptom.
Outcome measures
| Measure |
Placebo
n=9 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=7 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Change From Baseline in Clinician PRESORS Score
Day 3
|
0.03 units on scale
Standard Deviation 0.287
|
0.01 units on scale
Standard Deviation 0.212
|
|
Change From Baseline in Clinician PRESORS Score
Day 5
|
-0.32 units on scale
Standard Deviation 0.291
|
-0.04 units on scale
Standard Deviation 0.162
|
|
Change From Baseline in Clinician PRESORS Score
Day 8
|
-0.36 units on scale
Standard Deviation 0.167
|
-0.16 units on scale
Standard Deviation 0.151
|
|
Change From Baseline in Clinician PRESORS Score
Day 14
|
-0.42 units on scale
Standard Deviation 0.192
|
-0.10 units on scale
Standard Deviation 0.192
|
|
Change From Baseline in Clinician PRESORS Score
Day 21
|
-0.42 units on scale
Standard Deviation 0.192
|
-0.24 units on scale
Standard Deviation 0.276
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized.
Time to resolution from first dose of study drug until the first time of resolution of all RSV Symptoms (breathing problems, retractions, tachypnea, breathing sounds, cough, tachycardia, nasal secretions, sleep disturbance, crying, illness behavior, feeding problems, and dehydration). Resolution occurs when all symptoms from the caregiver reported outcomes (ObsRO) are scored as none or mild (score of 0 or 1, respectively) for at least 24 hours.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Time to Resolution of RSV Symptoms
|
194.00 Hours
Interval 164.2 to 238.0
|
118.60 Hours
Interval 17.0 to 238.0
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set was performed as randomized.
Time to improvement based on general questions on overall health was reported. Time from first dose of study drug until first time status of improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Time to Improvement on Overall Health
|
188.3 Hours
Interval 183.6 to 238.0
|
199.7 Hours
Interval 183.7 to 238.0
|
SECONDARY outcome
Timeframe: On Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21Population: ITT-i analysis set included all randomized participants who received at least one dose of study drug and who had a centrally confirmed RSV viral load of \>=1 log10 copies per mL above the LLOQ of the RSV RT-qPCR assay at baseline. Analyses on the ITT-i set were performed as randomized. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.
Percentage of participants with worsening or improvement of RSV disease based on general questions on overall health was reported. Improvement is defined improvement of RSV symptoms reported as "very much improved" or "much improved" based on response to question 'Would you say the child's RSV symptoms have improved, are about the same or are worse than when the child entered the study'.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 2 : Very Much Improved
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 2: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 3: Very Much Improved
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 3: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 4: Very Much Improved
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 4: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 5: Very Much Improved
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 6: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 7: Very Much Improved
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 7: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 9: Very Much Improved
|
60 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 9: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 10 Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 11 Very Much Improved
|
54.5 percentage of participants
|
37.5 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 12 Very Much Improved
|
54.5 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 12: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 13 Very Much Improved
|
90.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 17: Very Much Improved
|
87.5 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 17: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 18: Very Much Improved
|
88.9 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 18: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 19: Very Much Improved
|
90.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 19: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 20: Very Much Improved
|
88.9 percentage of participants
|
70.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 20: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 21: Very Much Improved
|
88.9 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 5: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 6: Very Much Improved
|
66.7 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 8: Very Much Improved
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 8: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 10: Very Much Improved
|
36.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 11: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 13: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 14: Very Much Improved
|
90.0 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 14: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 15: Very Much Improved
|
90.9 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 15: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 16: Very Much Improved
|
77.8 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 16: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Worsening or Improvement of RSV Disease
Day 21: Very Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 21 daysPopulation: Data was not collected due to low number of participants. Hence, no results are reported.
Time to return to pre-RSV health as rated by the parent(s)/caregiver(s) was evaluated. It is the time from first dose of study drug until the time to return to pre-RSV disease level.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 31Population: The Safety set (SAF) included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
Percentage of participants who require (re)hospitalization during treatment and follow-up were reported.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Percentage of Participants Who Require (re)Hospitalization During Treatment and Follow-up
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 31Population: The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Percentage of Participants With Adverse Events as a Measure of Safety and Tolerability
|
27.3 percentage of participants
|
27.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 31Population: The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed at specified categories.
Percentage of participants with abnormal chemistry laboratory findings (alanine aminotransferase \[ALT; Grade 1 and 4\], aspartate aminotransferase \[AST; Grade 1\], and Hyperkalemia \[Grade 1 and 2\]) were reported based on Division of Microbiology and Infectious Diseases (DMID) toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
|
|---|---|---|
|
Percentage of Participants With Abnormal Chemistry Laboratory Findings
ALT Increase - Grade 4
|
9.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Chemistry Laboratory Findings
AST- Grade 1
|
9.1 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Abnormal Chemistry Laboratory Findings
Hyperkalemia - Grade 2
|
10.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Chemistry Laboratory Findings
ALT Increase - Grade 1
|
9.1 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Chemistry Laboratory Findings
Hyperkalemia - Grade 1
|
30.0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 31Population: The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
Percentage of participants with abnormal urinalysis (Hematuria- Grade 1) laboratory finding was reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 1 = mild: transient or mild discomfort (\<48 hours); no medical intervention/therapy required. Grade 2 = moderate: mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Grade 3 = severe: marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible. Grade 4 = life-threatening or death: Extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable.
Outcome measures
| Measure |
Placebo
n=4 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=4 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
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|---|---|---|
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Percentage of Participants With Abnormal Urinalysis Laboratory Findings
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0 percentage of participants
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25.0 percentage of participants
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SECONDARY outcome
Timeframe: Up to Day 31Population: The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'N' (number of participants analyzed), included all participants who were evaluable for this outcome measure.
Percentage of participants with abnormal ECGs findings were reported. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB) Interval (\[450 milliseconds {ms}, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), QTc according to Fridericia's formula (QTcF) Interval (\[450 ms, 480 ms\], \[480 ms, 500 ms\], and \[more than 500 ms\]), change from baseline for QTcB Interval (\[30; 60\] ms, and greater than \[\>\] 60 ms), and for QTcF Interval (\[30; 60\] ms, and \>60 ms).
Outcome measures
| Measure |
Placebo
n=10 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
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JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
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|---|---|---|
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcB Interval (450 ms, 480 ms)
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20.0 percentage of participants
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9.1 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcB Interval (More than 500 ms)
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcF Interval (450 ms, 480 ms)
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0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcF Interval (480 ms, 500 ms)
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcF Interval (More than 500 ms)
|
0 percentage of participants
|
0 percentage of participants
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|
Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcB Interval (>60 ms)
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcF Interval (30; 60) ms
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0 percentage of participants
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9.1 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcF Interval (>60 ms)
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcB Interval (480 ms, 500 ms)
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Abnormal Electrocardiograms (ECGs) Findings
QTcB Interval (30; 60) ms
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0 percentage of participants
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9.1 percentage of participants
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SECONDARY outcome
Timeframe: Up to Day 31Population: The SAF included all participants who received at least 1 dose of study drug, and were analyzed as treated, regardless of the randomized treatment group assigned. Where 'analyzed as treated' is defined as: Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received. Here 'n' (number analyzed) included all participants who were analyzed for specified categories.
Percentage of participants with vital signs (systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\], pulse rate, respiratory rate, body temperature and peripheral capillary oxygen saturation \[SpO2\]) abnormalities (abnormally low \[ABL\] and abnormally high \[ABH\]) were reported.
Outcome measures
| Measure |
Placebo
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
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JNJ-53718678
n=11 Participants
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
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|---|---|---|
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Percentage of Participants With Vital Sign Abnormalities
DBP- ABH
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Pulse rate- ABL
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Respiratory Rate-ABH
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Temperature-ABL
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Temperature-ABH
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27.3 percentage of participants
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45.5 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Oxygen Saturation- ABL
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
SBP- ABL
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9.1 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
SBP- ABH
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0 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
DBP- ABL
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9.1 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Pulse rate- ABH
|
9.1 percentage of participants
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18.2 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Respiratory Rate-ABL
|
9.1 percentage of participants
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0 percentage of participants
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Percentage of Participants With Vital Sign Abnormalities
Oxygen Saturation- ABH
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0 percentage of participants
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0 percentage of participants
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SECONDARY outcome
Timeframe: Day 1 and Day 3Population: No data was collected for PK analysis due to small sample size. Hence, no results are reported.
No data was collected for pharmacokinetic (PK) analysis due to small sample size. Hence, no results are reported.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
JNJ-53718678
Serious adverse events
| Measure |
Placebo
n=11 participants at risk
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
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JNJ-53718678
n=11 participants at risk
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
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|---|---|---|
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Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
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9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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Infections and infestations
Tracheobronchitis
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0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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Other adverse events
| Measure |
Placebo
n=11 participants at risk
As per original dosing, participants were randomized to receive JNJ-53718678 matching placebo (for Age Group 1 \[greater than or equal to {\>=} 28 days and less than {\<} 3 months\], for Age Group 2 \[\>=3 and \<6 months\], and for Age Group 3 \[\>=6 months\]) orally once daily (qd) for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 matching placebo (for Age Groups 1, 2, and 3) orally twice daily (bid) for 7 days.
|
JNJ-53718678
n=11 participants at risk
As per original dosing, participants were randomized to receive JNJ-53718678 (for Age Group 1 \[\>= 28 days and \< 3 months\]: 5 milligrams/kilogram \[mg/kg\]; for Age Group 2 \[\>=3 and \<6 months\]: 6 mg/kg and for Age Group 3 \[\>=6 months\]: 9 mg/kg) orally qd for 7 days. After Protocol amendment 2, participants were randomized to receive JNJ-53718678 (for Age Group 1: 2.5 mg/kg; for Age Group 2: 3 mg/kg and for Age Group 3: 4.5 mg/kg) orally bid for 7 days
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|---|---|---|
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Cardiac disorders
Tachycardia
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0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
|
Infections and infestations
Gastroenteritis
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9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
9.1%
1/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
|
0.00%
0/11 • Up to Day 31
The safety analysis set (SAF) included all participants who were analyzed as treated, regardless of the randomized treatment group assigned for interventional stage. For interventional stage, 'analyzed as treated' is defined as; Placebo: if only placebo doses received, and JNJ-53718678: if at least one dose of the active study drug received.
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Additional Information
Senior director medical leader
Janssen Research & Development, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER