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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

Primary Purpose

Respiratory Syncytial Virus Infections

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

JNJ-53718678 500 mg

JNJ-53718678 80 mg

Placebo

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Core Healthcare Group
eStudySite
SC Clinical Research Inc
Lake Internal Medicine Associates
Florida Research Center Inc.
Family Medicine
William Beaumont Hospital
AllinaHealth - Abbott Northwestern Hospital (13520)
Mercury Street Medical Group, PLLC
Onsite Clinical Solutions
Unity Clinical Research
Spectrum Medical Research
Fusion Clinical Research of Spartanburg
Hospital Español De Bahia Blanca
Hospital Interzonal General de Agudos Dr. Jose Penna
Hospital Privado - Centro Medico de Cordoba
Fundación Respirar
Hospital Italiano de La Plata
HIGA Prof. Dr. Ramón Carrillo
Hospital Rawson
Hospital Italiano de Cordoba
Hospital Cordoba
Sanatorio Juan XXIII
Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)
Clinica Mayo de UMCB
Paratus Clinical Blacktown Clinic
Barwon Health - University Hospital Geelong
Paratus Clinical Kanwal Clinic
Paratus Clinical Kippa Ring Clinic
Mater Hospital Brisbane
Westmead Hospital
CHU Saint-Pierre
Jaak Mortelmans
BVBA Dr. Luc Capiau
Testumed
Santa Casa de Misericordia de Belo Horizonte
Faculdade de Medicina de Botucatu
Universidade Federal de Santa Catarina/Clínica Médica
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Hospital Sao Vicente de Paulo
Hospital São Lucas - PUCRS
Hospital Universitario Prof Edgard Santos
Hospital Alemão Oswaldo Cruz
Hospital Heliopolis
Hospital Sirio Libanes
MHAT 'Sv. Ivan Rilski' Kozloduy EOOD
Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik
SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD
MHAT 'Dr. Bratan Shukerov'
Diagnostic Consultation Centre 'Alexandrovska' EOOD
Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD
Aggarwal and associates Ltd
Milestone Research
Dr Anil K Gupta Medicine Professional Corporation
Clinique Force Medic (GCP Trials)
Centre Hospitalier d'Agen
Cabinet du Dr Remaud
Maison Medicale Rive Sud
CHU Nantes - Hotel Dieu
Cabinet du Dr Boye
Cabinet du Dr Baranes
MECS GmbH
IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum
Klinische Forschung Hannover-Mitte GmbH
Hausarztpraxis am Lindenplatz
Fukui General Clinic
Koukan Clinic
Shinkomonji hospital
Musashikoganei Clinic
Medical Square Kuhonji Clinic
Rinku General Medical Center
Tokyo Shinagawa Hospital
Saino Clinic
Toyota Kosei Hospital
Shin Yukuhashi Hospital
Soonchunhyang University Bucheon Hospital
Kyungpook National University Hospital
Gachon University Gil Hospital
Inha University Hospital
Kangnam Sacred Heart Hospital
Seoul Metropolitan Government Seoul National University Boramae Medical Center
The Catholic University of Korea St. Vincent's Hospital
Hospital Cardiologica Aguascalientes
Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
Hospital Civil de Guadalajara Fray Antonio Alcalde
RM Pharma Specialists
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis
Centrum Medyczne 'ALL-MED'
Diamond Clinic
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni
Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna
Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy
Krasnogorsk city hospital #1
City Polyclinic #25 of the Nevsky District of SPB
LLC 'Medical centr 'Reavita Med Spb'
Eco-safety Ltd
Research Institute of Influenza
Soweto Clinical Trial Centre
Newtown Clinical Research
Emmed Research
Welkom Clinical Trial Centre
Hosp. Gral. Univ. de Alicante
Hosp. Gral. Univ. de Elche
Hosp. Univ. Virgen de Las Nieves
Hosp. Univ. de La Princesa
Hosp. Clinico Univ. de Santiago
Hosp. Alvaro Cunqueiro
Skanes universitetssjukhus
Norrlands Universitetssjukhus
Akademiska Sjukhuset
Kaohsiung Veterans General Hospital
Taipei Medical University Shuang Ho Hospital
Kuang Tien General Hospital- Dajia
Far Eastern Memorial Hospital
Taipei Municipal Wanfang Hospital
Medical Center of LL Company 'Scientific Medical Center-Your Doctor'
Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
Policlinic of State Joint Stock Holding Company 'Artem'
Private Small Enterprise Medical Center Pulse
Medical Center Ltd 'Health Clinic', Department Of General Therapy
Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment A: JNJ-53718678 500 mg

Treatment B: JNJ-53718678 80 mg + Placebo

Treatment C: Placebo

Arm Description

Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.

Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Outcomes

Primary Outcome Measures

Area Under the Respiratory Syncytial Virus (RSV) Viral Load (VL)-Time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 3

Area under the RSV VL-time curve (AUC) was determined as log10 copies*hour per milliliter (Log10 copies*hr/mL) by quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Change From Baseline in RSV Viral Load at Day 3

Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 5

Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 8

Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 14

Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Change From Baseline in RSV Viral Load at Day 21

Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Baseline

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 3

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 5

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 8

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 14

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

RSV Viral Load at Day 21

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time to Undetectable RSV Viral Load

The time to undetectable nasal RSV RNA viral load was defined as the time in days from initiation of study treatment until first post-baseline time point at which RSV RNA was undetectable and after which time there were no more detectable virus assessments.

Percentage of Participants With Undetectable RSV Viral Load at Day 3

Percentage of participants with undetectable RSV viral load at Day 3 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 5

Percentage of participants with undetectable RSV viral load at Day 5 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 8

Percentage of participants with undetectable RSV viral load at Day 8 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 14

Percentage of participants with undetectable RSV viral load at Day 14 were reported.

Percentage of Participants With Undetectable RSV Viral Load at Day 21

Percentage of participants with undetectable RSV viral load at Day 21 were reported.

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities

Number of participants with worst treatment-emergent laboratory abnormalities (serum chemistry, hematology and urinalyses) were reported based on DMID toxicity grading scale. DMID toxicity grade categorized as Grade 1=mild(mild discomfort (< 48 hours); no medical intervention/therapy required), Grade 2= moderate (Moderate Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required), Grade 3= severe (severe Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible), and Grade 4=life threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization or hospice care probable).

Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities

Number of participants with worst treatment emergent vital sign abnormalities (including Systolic blood pressure [SBP] and diastolic blood pressure [DBP]) as abnormally low, mild increased, moderate increased and severe increased were reported. SBP: Abnormally low- Less than or equal to (<=) 50 mmHg, Grade 1 (mild)- 90 mmHg - < 100 mmHg, Grade 2 (moderate)- greater than or equal to (>=)100 mmHg to < 110 mmHg, Grade 3 (severe)- >=110 mmHg; DBP: Abnormally low- <=90 mmHg, Grade 1 (mild)- 140 mmHg - < 160 mmHg, Grade 2 (moderate)- >=160 mmHg to < 180 mmHg, Grade 3 (severe)- >=180 mmHg.

Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities

The number of participants with worst TE ECG abnormalities were reported. The ECG variables that were analyzed included heart rate, PR interval, QRS interval, QT interval, and corrected QT (QTc) interval. Parameters for abnormal ECG findings were QT interval corrected for heart rate (QTc) according to Bazett's formula (QTcB or Borderline Prolonged QTcB) Interval ([450 milliseconds {ms}, 480 ms], [480 ms, 500 ms], and [more than 500 ms]), QTc according to Fridericia's formula (QTcF or Borderline Prolonged QTcB) Interval ([450 ms, 480 ms], [480 ms, 500 ms], and [more than 500 ms]).

Peripheral Capillary Oxygen Saturation (SpO2) Over Time

Peripheral capillary oxygen saturation was measured by the investigator over time.

Change From Baseline in Peripheral Capillary Oxygen Saturation

Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.

Pulse Rate Over Time

Pulse rate was measured by the investigator over time.

Change From Baseline in Pulse Rate

Change from baseline in pulse rate was calculated and reported by the investigator.

Respiratory Rate Over Time

Respiratory rate was measured by the investigator over time.

Change From Baseline in Respiratory Rate

Change from baseline in respiratory rate was calculated and reported by the investigator.

Body Temperature Over Time

Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.

Change From Baseline in Body Temperature

Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.

Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose

AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.

Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire

The severity of signs and symptoms of RSV infection was assessed using the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO domain score ranges from 0 (symptom free) to 4 (very severe symptoms). Domain scores were calculated as the arithmetic mean of the scores for items within the domain.

Duration of Signs and Symptoms of RSV Assessed by RI-PRO

Duration of signs and symptoms of RSV infection was assessed by the time to resolution of all RSV symptoms from RI-PRO questionnaire. Resolution was defined as a score of 'Not at all/symptom-free' (score=0) or 'A little bit' (score=1) for at least 24 hours. The RI-PRO questionnaire is a 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items) and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).

Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire

Time to resolution of key RSV symptoms (congested or stuffy nose, sore or painful throat, trouble breathing, chest tightness, coughing, coughed up mucus or phlegm, weak or tired) as assessed by RI-PRO questionnaire was reported. Resolution of RSV symptoms was defined as a score of 'Not at all/symptom free' (score = 0) or 'A little bit' (score = 1) for at least 24 hours for symptoms of the RI-PRO questionnaire. The RI-PRO questionnaire is 32-item questionnaire. It summarizes severity of 6 symptom domains: nose (4 items), throat (3 items), eyes (3 items), chest/respiratory (7 items), gastrointestinal (4 items), and body/systemic (11 items). Each RI-PRO score ranges from 0 (symptom-free) to 4 (very severe symptoms).

Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire

Time from the first dose of study drug until the time to return to usual activity/health was determined. Return to usual activity/health when the response is 'Yes' on RI-PRO additional question 7 ('Have you returned to your usual activity/health today?') for at least 24 hours.

Predose Plasma Concentration (Ctrough) of JNJ-53718678

Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.

Maximum Plasma Concentration (Cmax) of JNJ-53718678

Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.

Full Information

NCT ID

NCT03379675

First Posted

December 15, 2017

Last Updated

June 22, 2022

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03379675

Brief Title

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

Official Title

A Pilot Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Subjects Infected With Respiratory Syncytial Virus

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

February 6, 2018 (Actual)

Primary Completion Date

November 27, 2019 (Actual)

Study Completion Date

December 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

This study will be performed to explore the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetics of JNJ-53718678 in adult participants infected with RSV. The study will include both participants who are otherwise healthy (ie, without underlying condition) or who have comorbid conditions (eg, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular disease, other chronic diseases), with the exception of immunocompromised participants, presenting for medical care but not requiring hospitalization. The study will include a screening period (Day -1 to Day 1), a treatment Period (Day 1 to Day 8), and a follow-up period (Day 9 to Day 28). Safety evaluations will include adverse events, laboratory tests, electrocardiogram, vital signs, physical examination, and specific toxicities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Syncytial Virus Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A: JNJ-53718678 500 mg

Arm Type

Experimental

Arm Description

Participants will receive 500 mg dose of JNJ-53718678 once daily for 7 days.

Arm Title

Treatment B: JNJ-53718678 80 mg + Placebo

Arm Type

Experimental

Arm Description

Participants will receive 80 mg dose of JNJ-53718678 along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Arm Title

Treatment C: Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678 500 mg

Intervention Description

Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

JNJ-53718678 80 mg

Intervention Description

Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline through Day 3

Title

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 5

Description

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Time Frame

Baseline through Day 5

Title

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 8

Description

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Time Frame

Baseline through Day 8

Title

Area Under the RSV VL-time Curve (AUC) From Immediately Prior to First Dose of Study Drug (Baseline) Through Day 14

Description

Area under the RSV VL-time curve (AUC) was determined as Log10 copies*hr/mL by qRT-PCR assay of mid turbine nasal swabs.

Time Frame

Baseline through Day 14

Title

Change From Baseline in RSV Viral Load at Day 3

Description

Change from baseline in RSV viral load at Day 3 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline to Day 3

Title

Change From Baseline in RSV Viral Load at Day 5

Description

Change from baseline in RSV viral load at Day 5 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline to Day 5

Title

Change From Baseline in RSV Viral Load at Day 8

Description

Change from baseline in RSV viral load at Day 8 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline to Day 8

Title

Change From Baseline in RSV Viral Load at Day 14

Description

Change from baseline in RSV viral load at Day 14 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline to Day 14

Title

Change From Baseline in RSV Viral Load at Day 21

Description

Change from baseline in RSV viral load oat Day 21 was measured as Log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline to Day 21

Title

RSV Viral Load at Baseline

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Baseline

Title

RSV Viral Load at Day 3

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Day 3

Title

RSV Viral Load at Day 5

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Day 5

Title

RSV Viral Load at Day 8

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Day 8

Title

RSV Viral Load at Day 14

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Day 14

Title

RSV Viral Load at Day 21

Description

RSV viral load was measured as log10 copies/mL by qRT-PCR assay in the mid-turbinate nasal swab specimens.

Time Frame

Day 21

Title

Time to Undetectable RSV Viral Load

Description

Time Frame

Up to Day 21

Title

Percentage of Participants With Undetectable RSV Viral Load at Day 3

Description

Percentage of participants with undetectable RSV viral load at Day 3 were reported.

Time Frame

Day 3

Title

Percentage of Participants With Undetectable RSV Viral Load at Day 5

Description

Percentage of participants with undetectable RSV viral load at Day 5 were reported.

Time Frame

Day 5

Title

Percentage of Participants With Undetectable RSV Viral Load at Day 8

Description

Percentage of participants with undetectable RSV viral load at Day 8 were reported.

Time Frame

Day 8

Title

Percentage of Participants With Undetectable RSV Viral Load at Day 14

Description

Percentage of participants with undetectable RSV viral load at Day 14 were reported.

Time Frame

Day 14

Title

Percentage of Participants With Undetectable RSV Viral Load at Day 21

Description

Percentage of participants with undetectable RSV viral load at Day 21 were reported.

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Description

Time Frame

Up to Day 28

Title

Number of Participants With Worst Treatment-Emergent Laboratory Abnormalities

Description

Time Frame

Up to Day 28

Title

Number of Participants With Worst Treatment-Emergent Vital Sign Abnormalities

Description

Time Frame

Up to Day 28

Title

Number of Participants With Worst Treatment-Emergent (TE) Electrocardiograms (ECGs) Abnormalities

Description

Time Frame

Up to Day 28

Title

Peripheral Capillary Oxygen Saturation (SpO2) Over Time

Description

Peripheral capillary oxygen saturation was measured by the investigator over time.

Time Frame

Baseline, Days 3, 8, 14, and 21

Title

Change From Baseline in Peripheral Capillary Oxygen Saturation

Description

Change from baseline in peripheral capillary oxygen saturation levels was calculated by the investigator.

Time Frame

Baseline to Days 3, 8, 14 and 21

Title

Pulse Rate Over Time

Description

Pulse rate was measured by the investigator over time.

Time Frame

Baseline, Days 3, 8, 14 and 21

Title

Change From Baseline in Pulse Rate

Description

Change from baseline in pulse rate was calculated and reported by the investigator.

Time Frame

Baseline to Days 3, 8, 14 and 21

Title

Respiratory Rate Over Time

Description

Respiratory rate was measured by the investigator over time.

Time Frame

Baseline, Days 3, 8, 14 and 21

Title

Change From Baseline in Respiratory Rate

Description

Change from baseline in respiratory rate was calculated and reported by the investigator.

Time Frame

Baseline to Days 3, 8, 14 and 21

Title

Body Temperature Over Time

Description

Body temperature was measured over time. Participants were provided a thermometer and asked to record body temperature in the electronic device.

Time Frame

Baseline, Days 3, 8, 14 and 21

Title

Change From Baseline in Body Temperature

Description

Change from baseline in body temperature was calculated and reported. Participants were provided a thermometer and asked to record body temperature in the electronic device.

Time Frame

Baseline to Days 3, 5, 8, 14 and 21

Title

Area Under the Plasma Concentration-Time Curve From Time Point 0 Hours Until 24 Hours Post Dose

Description

AUC (0-24) is defined as area under the plasma concentration-time curve from time point 0 hours until 24 hours post dose.

Time Frame

0 to 24 hours post dose on Days 1 and 7

Title

Severity of Signs and Symptoms of RSV Assessed by Respiratory Infection-Patient Reported Outcomes (RI-PRO) Questionnaire

Description

Time Frame

Baseline, Days 3, 5, 8, 14 and 21

Title

Duration of Signs and Symptoms of RSV Assessed by RI-PRO

Description

Time Frame

Baseline up to Day 21

Title

Time to Resolution of Key RSV Symptoms as Assessed by RI-PRO Questionnaire

Description

Time Frame

Up to Day 21

Title

Time to Return to Usual Activity/Health Based on RI-PRO Questionnaire

Description

Time Frame

Up to Day 21

Title

Predose Plasma Concentration (Ctrough) of JNJ-53718678

Description

Ctrough is the trough plasma concentration of JNJ-53718678 estimated by population PK model.

Time Frame

Predose on Days 1 and 7

Title

Maximum Plasma Concentration (Cmax) of JNJ-53718678

Description

Cmax is the maximum plasma concentration of JNJ-53718678 estimated by population PK model.

Time Frame

Days 1 and 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Core Healthcare Group

City

Cerritos

State/Province

California

ZIP/Postal Code

90703

Country

United States

Facility Name

eStudySite

City

Chula Vista

State/Province

California

ZIP/Postal Code

919111

Country

United States

Facility Name

SC Clinical Research Inc

City

Garden Grove

State/Province

California

ZIP/Postal Code

92844

Country

United States

Facility Name

Lake Internal Medicine Associates

City

Eustis

State/Province

Florida

ZIP/Postal Code

32726

Country

United States

Facility Name

Florida Research Center Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Family Medicine

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83686

Country

United States

Facility Name

William Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

AllinaHealth - Abbott Northwestern Hospital (13520)

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

Mercury Street Medical Group, PLLC

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Onsite Clinical Solutions

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Unity Clinical Research

City

Lindsay

State/Province

Oklahoma

ZIP/Postal Code

73052

Country

United States

Facility Name

Spectrum Medical Research

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29341

Country

United States

Facility Name

Fusion Clinical Research of Spartanburg

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29301

Country

United States

Facility Name

Hospital Español De Bahia Blanca

City

Bahia Blanca

ZIP/Postal Code

8000

Country

Argentina

Facility Name

Hospital Interzonal General de Agudos Dr. Jose Penna

City

Bahia Blanca

ZIP/Postal Code

B8001DDU

Country

Argentina

Facility Name

Hospital Privado - Centro Medico de Cordoba

City

Barrio Parque Velez Sarfield

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Fundación Respirar

City

Caba

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Hospital Italiano de La Plata

City

Ciudad De La Plata

ZIP/Postal Code

B1900AX

Country

Argentina

Facility Name

HIGA Prof. Dr. Ramón Carrillo

City

Ciudadela

ZIP/Postal Code

1702

Country

Argentina

Facility Name

Hospital Rawson

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

Hospital Italiano de Cordoba

City

Cordoba

ZIP/Postal Code

X5004BAL

Country

Argentina

Facility Name

Hospital Cordoba

City

Cordoba

ZIP/Postal Code

X5004CDT

Country

Argentina

Facility Name

Sanatorio Juan XXIII

City

General Roca

ZIP/Postal Code

8332

Country

Argentina

Facility Name

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN)

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

Clinica Mayo de UMCB

City

San Miguel de Tucuman

ZIP/Postal Code

T4000IHE

Country

Argentina

Facility Name

Paratus Clinical Blacktown Clinic

City

Blacktown

ZIP/Postal Code

2060

Country

Australia

Facility Name

Barwon Health - University Hospital Geelong

City

Geelong

ZIP/Postal Code

3220

Country

Australia

Facility Name

Paratus Clinical Kanwal Clinic

City

Kanwal

ZIP/Postal Code

2059

Country

Australia

Facility Name

Paratus Clinical Kippa Ring Clinic

City

Kippa Ring

ZIP/Postal Code

4021

Country

Australia

Facility Name

Mater Hospital Brisbane

City

South Brisbane

ZIP/Postal Code

4101

Country

Australia

Facility Name

Westmead Hospital

City

Sydney

ZIP/Postal Code

2145

Country

Australia

Facility Name

CHU Saint-Pierre

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Jaak Mortelmans

City

Ham

ZIP/Postal Code

3945

Country

Belgium

Facility Name

BVBA Dr. Luc Capiau

City

Massemen

ZIP/Postal Code

9230

Country

Belgium

Facility Name

Testumed

City

Tessenderlo

ZIP/Postal Code

3980

Country

Belgium

Facility Name

Santa Casa de Misericordia de Belo Horizonte

City

Belo Horizonte

ZIP/Postal Code

30150-221

Country

Brazil

Facility Name

Faculdade de Medicina de Botucatu

City

Botucatu

ZIP/Postal Code

18618-970

Country

Brazil

Facility Name

Universidade Federal de Santa Catarina/Clínica Médica

City

Florianopolis

ZIP/Postal Code

88036-800

Country

Brazil

Facility Name

Centro de Estudos e Pesquisas em Moléstias Infecciosas

City

Natal

ZIP/Postal Code

59025-050

Country

Brazil

Facility Name

Hospital Sao Vicente de Paulo

City

Passo Fundo

ZIP/Postal Code

99010-080

Country

Brazil

Facility Name

Hospital São Lucas - PUCRS

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Hospital Universitario Prof Edgard Santos

City

Salvador

ZIP/Postal Code

40110-160

Country

Brazil

Facility Name

Hospital Alemão Oswaldo Cruz

City

Sao Paulo

ZIP/Postal Code

01421-000

Country

Brazil

Facility Name

Hospital Heliopolis

City

Sao Paulo

ZIP/Postal Code

04231-030

Country

Brazil

Facility Name

Hospital Sirio Libanes

City

São Paulo

ZIP/Postal Code

01308-050

Country

Brazil

Facility Name

MHAT 'Sv. Ivan Rilski' Kozloduy EOOD

City

Kozloduy

ZIP/Postal Code

3320

Country

Bulgaria

Facility Name

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik

City

Pernik

ZIP/Postal Code

2000

Country

Bulgaria

Facility Name

SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

MHAT 'Dr. Bratan Shukerov'

City

Smolyan

ZIP/Postal Code

4703

Country

Bulgaria

Facility Name

Diagnostic Consultation Centre 'Alexandrovska' EOOD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD

City

Troyan

ZIP/Postal Code

5600

Country

Bulgaria

Facility Name

Aggarwal and associates Ltd

City

Brampton

State/Province

Ontario

Country

Canada

Facility Name

Milestone Research

City

London

State/Province

Ontario

ZIP/Postal Code

N5W 6A2

Country

Canada

Facility Name

Dr Anil K Gupta Medicine Professional Corporation

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Clinique Force Medic (GCP Trials)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Centre Hospitalier d'Agen

City

Agen cedex 9

ZIP/Postal Code

47923

Country

France

Facility Name

Cabinet du Dr Remaud

City

Angers

ZIP/Postal Code

49000

Country

France

Facility Name

Maison Medicale Rive Sud

City

Murs Erigne

ZIP/Postal Code

49610

Country

France

Facility Name

CHU Nantes - Hotel Dieu

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Cabinet du Dr Boye

City

Nantes

ZIP/Postal Code

44300

Country

France

Facility Name

Cabinet du Dr Baranes

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

MECS GmbH

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Klinische Forschung Hannover-Mitte GmbH

City

Hannover

ZIP/Postal Code

30159

Country

Germany

Facility Name

Hausarztpraxis am Lindenplatz

City

Luebeck

ZIP/Postal Code

23554

Country

Germany

Facility Name

Fukui General Clinic

City

Fukui-shi

ZIP/Postal Code

910-0067

Country

Japan

Facility Name

Koukan Clinic

City

Kawasaki

ZIP/Postal Code

210-0852

Country

Japan

Facility Name

Shinkomonji hospital

City

Kitakyusyu

ZIP/Postal Code

800-0057

Country

Japan

Facility Name

Musashikoganei Clinic

City

Koganei-Shi

ZIP/Postal Code

184-0004

Country

Japan

Facility Name

Medical Square Kuhonji Clinic

City

Kumamoto-shi

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Rinku General Medical Center

City

Osaka

ZIP/Postal Code

598-8577

Country

Japan

Facility Name

Tokyo Shinagawa Hospital

City

Shinagawa-ku

ZIP/Postal Code

140-8522

Country

Japan

Facility Name

Saino Clinic

City

Tokorozawa-shi

ZIP/Postal Code

359-1141

Country

Japan

Facility Name

Toyota Kosei Hospital

City

Toyota

ZIP/Postal Code

470-0396

Country

Japan

Facility Name

Shin Yukuhashi Hospital

City

Yukuhashi

ZIP/Postal Code

824-0026

Country

Japan

Facility Name

Soonchunhyang University Bucheon Hospital

City

Bucheon

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Kyungpook National University Hospital

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

Gachon University Gil Hospital

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Inha University Hospital

City

Incheon

ZIP/Postal Code

22322

Country

Korea, Republic of

Facility Name

Kangnam Sacred Heart Hospital

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

Seoul Metropolitan Government Seoul National University Boramae Medical Center

City

Seoul

ZIP/Postal Code

7061

Country

Korea, Republic of

Facility Name

The Catholic University of Korea St. Vincent's Hospital

City

Suwon-si

ZIP/Postal Code

16247

Country

Korea, Republic of

Facility Name

Hospital Cardiologica Aguascalientes

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

City

Guadalajara

ZIP/Postal Code

44130

Country

Mexico

Facility Name

Hospital Civil de Guadalajara Fray Antonio Alcalde

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Facility Name

RM Pharma Specialists

City

Mexico

ZIP/Postal Code

03100

Country

Mexico

Facility Name

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis

City

Kielce

ZIP/Postal Code

25-751

Country

Poland

Facility Name

Centrum Medyczne 'ALL-MED'

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

Diamond Clinic

City

Krakow

ZIP/Postal Code

31-559

Country

Poland

Facility Name

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni

City

Lodz

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna

City

Ostrow Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

City

Wroclaw

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Krasnogorsk city hospital #1

City

Krasnogorsk

ZIP/Postal Code

143408

Country

Russian Federation

Facility Name

City Polyclinic #25 of the Nevsky District of SPB

City

Saint-Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

LLC 'Medical centr 'Reavita Med Spb'

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Eco-safety Ltd

City

Saint-Petersburg

ZIP/Postal Code

196143

Country

Russian Federation

Facility Name

Research Institute of Influenza

City

St. Petersburg

ZIP/Postal Code

197376

Country

Russian Federation

Facility Name

Soweto Clinical Trial Centre

City

Johannesburg

ZIP/Postal Code

1818

Country

South Africa

Facility Name

Newtown Clinical Research

City

Johannesburg

ZIP/Postal Code

2001

Country

South Africa

Facility Name

Emmed Research

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Welkom Clinical Trial Centre

City

Welkom

ZIP/Postal Code

9460

Country

South Africa

Facility Name

Hosp. Gral. Univ. de Alicante

City

Alicante

ZIP/Postal Code

3010

Country

Spain

Facility Name

Hosp. Gral. Univ. de Elche

City

Elche

ZIP/Postal Code

3203

Country

Spain

Facility Name

Hosp. Univ. Virgen de Las Nieves

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Hosp. Univ. de La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hosp. Clinico Univ. de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hosp. Alvaro Cunqueiro

City

Vigo

ZIP/Postal Code

36213

Country

Spain

Facility Name

Skanes universitetssjukhus

City

Malmö

ZIP/Postal Code

20502

Country

Sweden

Facility Name

Norrlands Universitetssjukhus

City

Umeå

ZIP/Postal Code

90185

Country

Sweden

Facility Name

Akademiska Sjukhuset

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

Facility Name

Taipei Medical University Shuang Ho Hospital

City

New Taipei

ZIP/Postal Code

23561

Country

Taiwan

Facility Name

Kuang Tien General Hospital- Dajia

City

Taichung City

ZIP/Postal Code

437

Country

Taiwan

Facility Name

Far Eastern Memorial Hospital

City

Taipei City

ZIP/Postal Code

220

Country

Taiwan

Facility Name

Taipei Municipal Wanfang Hospital

City

Taipei

ZIP/Postal Code

11696

Country

Taiwan

Facility Name

Medical Center of LL Company 'Scientific Medical Center-Your Doctor'

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education

City

Kharkiv

ZIP/Postal Code

61106

Country

Ukraine

Facility Name

Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'

City

Kherson

ZIP/Postal Code

73000

Country

Ukraine

Facility Name

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Policlinic of State Joint Stock Holding Company 'Artem'

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Private Small Enterprise Medical Center Pulse

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

Medical Center Ltd 'Health Clinic', Department Of General Therapy

City

Vinnytsya

ZIP/Postal Code

21009

Country

Ukraine

Facility Name

Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University

City

Vinnytsya

ZIP/Postal Code

21021

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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