Phase 2
Completed N=72
A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus
Source: ClinicalTrials.gov NCT03379675 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 — 207.3; 246.3; 203.4 Log10 copies*hr/mL
Summary
The purpose of this study is to explore the antiviral effect of JNJ-53718678 at 2 dose levels (80 milligrams [mg] and 500 mg) once daily for 7 days in adults with Respiratory Syncytial Virus (RSV) infection, as measured by RSV viral load in nasal secretions by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3 |
207.3; 246.3; 203.4 | — |
| PRIMARY Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5 |
344.5; 424.2; 340.4 | — |
| PRIMARY Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8 |
470.7; 612.3; 486.1 | — |
| PRIMARY Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14 |
534.4; 747.1; 619.9 | — |
| PRIMARY Change From Baseline in RSV Viral Load at Day 3 |
-2.210; -1.436; -2.221 | — |
| PRIMARY Change From Baseline in RSV Viral Load at Day 5 |
-3.156; -2.324; -3.031 | — |
| PRIMARY Change From Baseline in RSV Viral Load at Day 8 |
-4.960; -3.983; -3.953 | — |
| PRIMARY Change From Baseline in RSV Viral Load at Day 14 |
-5.135; -5.777; -4.858 | — |
| PRIMARY Change From Baseline in RSV Viral Load at Day 21 |
-5.433; -5.898; -5.129 | — |
| PRIMARY RSV Viral Load at Baseline |
5.523; 5.851; 5.285 | — |
| PRIMARY RSV Viral Load at Day 3 |
3.267; 4.448; 3.160 | — |
| PRIMARY RSV Viral Load at Day 5 |
2.384; 3.528; 2.351 | — |
| PRIMARY RSV Viral Load at Day 8 |
0.661; 1.804; 1.398 | — |
| PRIMARY RSV Viral Load at Day 14 |
0.421; 0.290; 0.492 | — |
| PRIMARY RSV Viral Load at Day 21 |
0.108; 0.113; 0.253 | — |
| PRIMARY Time to Undetectable RSV Viral Load |
7.0; 8.0; 9.7 | — |
| PRIMARY Percentage of Participants With Undetectable RSV Viral Load at Day 3 |
28.6; 5.0; 20.0 | — |
| PRIMARY Percentage of Participants With Undetectable RSV Viral Load at Day 5 |
40.0; 14.3; 35.0 | — |
| PRIMARY Percentage of Participants With Undetectable RSV Viral Load at Day 8 |
83.3; 45.0; 52.4 | — |
| PRIMARY Percentage of Participants With Undetectable RSV Viral Load at Day 14 |
89.5; 88.9; 78.9 | — |
| PRIMARY Percentage of Participants With Undetectable RSV Viral Load at Day 21 |
95.0; 94.7; 90.0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability |
9; 18; 15 | — |
| SECONDARY Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities |
1; 0; 1; 1; 0; 2 | — |
| SECONDARY Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities |
0; 0; 2; 0; 3; 0 | — |
| SECONDARY Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Peripheral Capillary Oxygen Saturation (SpO2) Over Time |
95.6; 96.0; 95.8; 95.8; 96.8; 95.7 | — |
| SECONDARY Change From Baseline in Peripheral Capillary Oxygen Saturation |
0.5; 0.9; 0.2; 1.3; 0.5; 1.1 | — |
| SECONDARY Pulse Rate Over Time |
76.9; 78.0; 77.8; 76.4; 76.6; 78.7 | — |
| SECONDARY Change From Baseline in Pulse Rate |
0.0; -1.4; 0.2; -5.4; -3.5; -6.4 | — |
| SECONDARY Respiratory Rate Over Time |
18.2; 18.0; 19.2; 17.1; 16.7; 18.3 | — |
| SECONDARY Change From Baseline in Respiratory Rate |
-0.9; -1.3; -0.8; -1.4; -0.6; -1.1 | — |
| SECONDARY Body Temperature Over Time |
36.83; 36.73; 36.75; 36.57; 36.65; 36.69 | — |
| SECONDARY Change From Baseline in Body Temperature |
-0.27; -0.11; -0.01; -0.63; -0.41; -0.17 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose |
29800; 4530; 41200; 5470 | — |
| SECONDARY Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire |
2.32; 2.16; 1.91; 1.84; 1.01; 1.25 | — |
| SECONDARY Duration of Signs and Symptoms of RSV Assessed by RI-PRO |
7.9; 7.4; 15.9 | — |
| SECONDARY Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire |
7.1; 7.6; 9.6 | — |
| SECONDARY Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire |
6.0; 3.0; 5.6; 8.3; 8.6; 9.1 | — |
| SECONDARY Predose Plasma Concentration (Ctrough) of JNJ-53718678 |
514; 68.2; 774; 84.4 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of JNJ-53718678 |
2870; 490; 3540; 552 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have an acute respiratory illness with signs and symptoms consistent with a viral infection (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 time the participant becomes aware of the first sign and/or symptom consistent with a viral infection
- Participant has been diagnosed with respiratory syncytial virus (RSV) infection using a rapid polymerase chain reaction (PCR) based or rapid-antigen-detection test
- Before randomization, a woman must be not of childbearing potential defined as: Premenarchal, Postmenopausal or Permanently sterile
- A male participant must agree to the use of acceptable contraceptive measures
- With the exception of the RSV-related illness the participant must be medically stable on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG) performed at screening
Exclusion Criteria
- Hospitalized participants or participants expected to be hospitalized within 24 hours of screening
- History of or concurrent illness (beyond a comorbid condition) that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments
- Participants who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
- Participants who are considered by the investigator to be immunocompromised within the past 12 months
- Participant has known or suspected chronic or acute hepatitis B or C infection
- Women who are pregnant or breastfeeding
- Participants with clinically significant abnormal ECG findings (other than QT-interval corrected for heart rate according to Fridericia [QTcF] interval greater than [>] 500 millisecond [ms]) not consistent with the underlying condition in the study population, as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT03379675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.