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A Study of Acute Respiratory Infections in Global Outpatient Setting (ARGOS)

Primary Purpose

Acute Respiratory Infection

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Nasal Swab Sample
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Infection focused on measuring Respiratory syncytial virus (RSV), Flu, COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • Present to the general physician (GP)/specialist outpatient settings/respiratory clinics or in Emergency department (ED) settings with symptoms suggestive of a diagnosis of Acute Respiratory Infections (ARI)
  • For inclusion in the home-based follow-up phases, must test positive for respiratory syncytial virus (RSV) and/or influenza and/or Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) per a molecular-based diagnostic assay (polymerase chain reaction [PCR]-based) using a nasal swab (nasopharyngeal or similar) sample. Co-infections are permitted to be enrolled in the study
  • Must be able to read, understand, and complete questionnaires
  • Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
  • Willing and able to adhere to the specifications in this protocol

Exclusion Criteria:

  • Has a clinical condition other than those as specified in study protocol which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments
  • Received an investigational drug (including investigational vaccines) within 3 months before the start of the study or the first data collection time-point
  • Is currently enrolled or plans to participate in another investigational study on RSV, influenza or SARS-CoV-2 during the current study
  • Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study, or is unlikely to complete the full course of observation
  • Cannot communicate reliably with the investigator

Sites / Locations

  • Central Alabama Research
  • Lakeview Clinical Research
  • Synexus Clinical Research US, Inc
  • Fiel Family and Sports Medicine Clinical Research Advantage
  • Harrisburg Family Medical Center
  • Innovative Research of West Florida, Incorporated
  • New Life Medical Research Center, Inc.
  • Best Quality Research Inc
  • PharmaDUX Clinical Medical Research, LLC
  • Homestead Associates in Research,Inc
  • Alma Clinical Research
  • Research Institute of South Florida Inc
  • Pines Care Research Center Inc
  • Santos Research Center
  • Columbus Regional Research Institute
  • IACT Health
  • Snake River Research, PLLC
  • Washington University School of Medicine
  • Montana Medical Research
  • Healor Primary Care
  • Las Vegas Medical Research
  • Santa Rosa Medical Centers of Nevada
  • Urgent Care Clinical Trials at AFC Urgent Care
  • Montefiore Medical Center
  • American Health Network, LLC
  • Duke University Medical Center
  • DayStar Clinical Research, Inc.
  • Urgent Care Clinical Trials at AFC Urgent Care
  • Premier Family Physicians
  • Next Level Urgent Care
  • Southwest Family Medicine Associates
  • Urgent Care Clinical Trials Fort Worth
  • Southwest Clinical Trials
  • Renovatio Clinical
  • Benchmark Research
  • CCT Research at Olympus Family Medicine
  • CCT Research at South Ogden Family Medicine
  • Clinical Research Partners, LLC
  • IACT Health
  • ALTA Clinical Research Inc.
  • CHU Grenoble
  • Hopital Edouard Herriot - CHU Lyon
  • CHU Nimes - Hôpital Carémeau
  • Fujita Health University Hospital
  • Hanasaki Clinic
  • Miyagikoseikyokai Saka General Hospital
  • Inje University Busan Paik Hospital
  • Korea University Ansan Hospital
  • Gachon University Gil Medical Center
  • Hallym University Kangnam Sacred Heart Hospital
  • Klinik Kesihatan Putrajaya Presint 9
  • Klinik Kesihatan Kuang
  • Klinik Kesihatan Masjid Tanah
  • Hospital Miri
  • Gabinet Lekarski Pediatryczno-Alergologiczny
  • NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
  • ETG Lodz
  • EMC Instytut Medyczny SA PL CERTUS
  • NZOZ Leczniczo-Rehabilitacyjny Ośrodek Medycyny Rodzinnej
  • Cs Algeciras Norte
  • Hosp. Gral. Univ. de Alicante
  • Eap Sardenya
  • Cap Apenins - Montigala
  • Cap Canet de Mar
  • Hosp. Clinico San Carlos
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei Medical University Shuang Ho Hospital
  • Taipei Medical University
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Taipei Municipal Wanfang Hospital
  • The Adam Practice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participants with Acute Respiratory Infections (ARI) in Outpatient Setting

Arm Description

Participants presenting with ARIs in an outpatient setting who are at high risk of progressing to severe disease will be screened for viral respiratory pathogens (respiratory syncytial virus [RSV], Influenza, severe acute respiratory syndrome coronavirus 2 [SARS-COV-2]) by collecting a nasal swab. If a participant is positive for RSV and/or influenza virus and/or SARS-CoV-2 based on a study test or standard-of-care (SOC) polymerase chain reaction (PCR)-based test, the participant will be eligible for enrollment in the study in the home-based short-term and long-term follow-up phases.

Outcomes

Primary Outcome Measures

Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Percentage of Participants Positive for Influenza Virus
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Number of Participants with Relative Risk of Acute Respiratory Infections (ARI)- related Hospitalization in Participants Positive for RSV with Lower Respiratory Tract Disease (LRTD) or Without LRTD
Number of participants with relative risk of ARI-related hospitalization in participants positive for RSV with LRTD or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the Respiratory Infection Intensity and Impact Questionnaire (RiiQTM) V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.

Secondary Outcome Measures

Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
Number of participants with relative risk of ARI-related hospitalization in participants positive for influenza virus diagnosed with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
Number of participants with relative risk of ARI-related hospitalization in participants positive for SARS-CoV-2 with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
Percentage of participants positive for influenza virus reporting ARI-related hospitalizations during the study period will be reported.
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
Percentage of participants positive for SARS-CoV-2 reporting ARI-related hospitalizations during the study period will be reported.
Time to ARI- related Hospitalization in Participants Positive for RSV
Time to ARI- related hospitalization in participants positive for RSV will be reported.
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.

Full Information

First Posted
November 25, 2021
Last Updated
August 16, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05148780
Brief Title
A Study of Acute Respiratory Infections in Global Outpatient Setting
Acronym
ARGOS
Official Title
Acute Respiratory Infections Global Outpatient Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
February 20, 2023 (Actual)
Study Completion Date
February 22, 2023 (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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the positivity rate of respiratory syncytial virus (RSV), influenza virus and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in high-risk participants presenting with acute respiratory infections (ARIs) in outpatient settings during the influenza/RSV season and to evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.
Detailed Description
Lower respiratory tract infections (LRTIs) are a major cause of mortality and morbidity worldwide with 2.3 million deaths in 2016 alone among all age groups, making it the sixth leading cause of mortality. The current study aims to assess the burden of RSV infections among adult participants presenting in outpatient settings, who are at high risk of complications or progression to severe disease due to their age or pre-existing comorbidities. Regional data from the United States (US), Europe, Middle East, and Asia (EMEA) and Asia-Pacific (APAC) will provide evidence on local RSV morbidity, mortality, medical resource utilization (MRU), standard of care, and quality of life in adults participants. A subset of participants positive for influenza virus and/or SARS-CoV-2 will also be enrolled, to allow for a comparative assessment of disease burden between the 3 viral respiratory pathogens. No study drug will be involved in this study. The total duration of the study for each participant will be a maximum of 3 months (+-1 week) from the date of enrollment. Safety will be assessed in the form of adverse events and serious adverse events related to study devices or procedures and for deaths regardless of causality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection
Keywords
Respiratory syncytial virus (RSV), Flu, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Acute Respiratory Infections (ARI) in Outpatient Setting
Arm Type
Other
Arm Description
Participants presenting with ARIs in an outpatient setting who are at high risk of progressing to severe disease will be screened for viral respiratory pathogens (respiratory syncytial virus [RSV], Influenza, severe acute respiratory syndrome coronavirus 2 [SARS-COV-2]) by collecting a nasal swab. If a participant is positive for RSV and/or influenza virus and/or SARS-CoV-2 based on a study test or standard-of-care (SOC) polymerase chain reaction (PCR)-based test, the participant will be eligible for enrollment in the study in the home-based short-term and long-term follow-up phases.
Intervention Type
Diagnostic Test
Intervention Name(s)
Nasal Swab Sample
Intervention Description
Nasal swab sample will be used to screen participants for detection of viral pathogens. No intervention or study drug will be administered as part of this study.
Primary Outcome Measure Information:
Title
Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
Description
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Time Frame
Day 1
Title
Percentage of Participants Positive for Influenza Virus
Description
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Time Frame
Day 1
Title
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Description
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Time Frame
Day 1
Title
Number of Participants with Relative Risk of Acute Respiratory Infections (ARI)- related Hospitalization in Participants Positive for RSV with Lower Respiratory Tract Disease (LRTD) or Without LRTD
Description
Number of participants with relative risk of ARI-related hospitalization in participants positive for RSV with LRTD or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the Respiratory Infection Intensity and Impact Questionnaire (RiiQTM) V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
Description
Number of participants with relative risk of ARI-related hospitalization in participants positive for influenza virus diagnosed with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing.
Time Frame
Up to 3 months
Title
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
Description
Number of participants with relative risk of ARI-related hospitalization in participants positive for SARS-CoV-2 with or without LRTD will be reported. LRTD is defined as new onset or worsening from chronic condition of 3 or more of the below symptoms as captured in the RiiQTM V2 at the same assessment time-point: Cough, Short of breath, Coughing up phlegm (sputum), Wheezing
Time Frame
Up to 3 months
Title
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
Description
Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
Time Frame
Up to 3 months
Title
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
Description
Percentage of participants positive for influenza virus reporting ARI-related hospitalizations during the study period will be reported.
Time Frame
Up to 3 months
Title
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
Description
Percentage of participants positive for SARS-CoV-2 reporting ARI-related hospitalizations during the study period will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Hospitalization in Participants Positive for RSV
Description
Time to ARI- related hospitalization in participants positive for RSV will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
Description
Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
Description
Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
Time Frame
Up to 3 months
Title
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
Description
Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
Time Frame
Day 1
Title
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
Description
Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
Description
Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
Description
Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
Time Frame
Up to 3 months
Title
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
Description
Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
Time Frame
Up to 3 months
Title
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
Description
Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
Time Frame
Day 1
Title
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
Description
Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
Time Frame
Up to 3 months
Title
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
Time Frame
Up to 3 months
Title
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
Time Frame
Up to 3 months
Title
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Present to the general physician (GP)/specialist outpatient settings/respiratory clinics or in Emergency department (ED) settings with symptoms suggestive of a diagnosis of Acute Respiratory Infections (ARI) For inclusion in the home-based follow-up phases, must test positive for respiratory syncytial virus (RSV) and/or influenza and/or Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) per a molecular-based diagnostic assay (polymerase chain reaction [PCR]-based) using a nasal swab (nasopharyngeal or similar) sample. Co-infections are permitted to be enrolled in the study Must be able to read, understand, and complete questionnaires Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study Willing and able to adhere to the specifications in this protocol Exclusion Criteria: Has a clinical condition other than those as specified in study protocol which, in the opinion of the investigator, could prevent, confound, or limit the protocol-specified assessments Received an investigational drug (including investigational vaccines) within 3 months before the start of the study or the first data collection time-point Is currently enrolled or plans to participate in another investigational study on RSV, influenza or SARS-CoV-2 during the current study Is, in the opinion of the investigator, unlikely to adhere to the requirements of the study, or is unlikely to complete the full course of observation Cannot communicate reliably with 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
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Lakeview Clinical Research
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Fiel Family and Sports Medicine Clinical Research Advantage
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
Innovative Research of West Florida, Incorporated
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
New Life Medical Research Center, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Best Quality Research Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
PharmaDUX Clinical Medical Research, LLC
City
Medley
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Homestead Associates in Research,Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Alma Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Institute of South Florida Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Pines Care Research Center Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
IACT Health
City
Rincon
State/Province
Georgia
ZIP/Postal Code
31326
Country
United States
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Healor Primary Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Santa Rosa Medical Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Urgent Care Clinical Trials at AFC Urgent Care
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
American Health Network, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
DayStar Clinical Research, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44313
Country
United States
Facility Name
Urgent Care Clinical Trials at AFC Urgent Care
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Premier Family Physicians
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Next Level Urgent Care
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Urgent Care Clinical Trials Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Renovatio Clinical
City
Magnolia
State/Province
Texas
ZIP/Postal Code
77354
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
CCT Research at Olympus Family Medicine
City
Holladay
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
CCT Research at South Ogden Family Medicine
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Clinical Research Partners, LLC
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
IACT Health
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
ALTA Clinical Research Inc.
City
Edmonton
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
CHU Grenoble
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Edouard Herriot - CHU Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Nimes - Hôpital Carémeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Fujita Health University Hospital
City
Date-gun
ZIP/Postal Code
969-1793
Country
Japan
Facility Name
Hanasaki Clinic
City
Kiyosu-shi
ZIP/Postal Code
452-0001
Country
Japan
Facility Name
Miyagikoseikyokai Saka General Hospital
City
Shiogama
ZIP/Postal Code
985-8506
Country
Japan
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
7441
Country
Korea, Republic of
Facility Name
Klinik Kesihatan Putrajaya Presint 9
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Klinik Kesihatan Kuang
City
Kuang
ZIP/Postal Code
48050
Country
Malaysia
Facility Name
Klinik Kesihatan Masjid Tanah
City
Masjid Tanah
ZIP/Postal Code
78300
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Gabinet Lekarski Pediatryczno-Alergologiczny
City
Bialystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
ETG Lodz
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
EMC Instytut Medyczny SA PL CERTUS
City
Poznan
ZIP/Postal Code
60-309
Country
Poland
Facility Name
NZOZ Leczniczo-Rehabilitacyjny Ośrodek Medycyny Rodzinnej
City
Wrocław
ZIP/Postal Code
53-021
Country
Poland
Facility Name
Cs Algeciras Norte
City
Algeciras
ZIP/Postal Code
11202
Country
Spain
Facility Name
Hosp. Gral. Univ. de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Eap Sardenya
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Cap Apenins - Montigala
City
Caldes Montbui Canovelles
ZIP/Postal Code
3308140
Country
Spain
Facility Name
Cap Canet de Mar
City
Canet de Mar
ZIP/Postal Code
08360
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Taipei Medical University Shuang Ho Hospital
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Taipei Municipal Wanfang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
The Adam Practice
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Acute Respiratory Infections in Global Outpatient Setting

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