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

January 31, 2025 updated by: Janssen Research & Development, LLC

Acute Respiratory Infections Global Outpatient Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • ALTA Clinical Research Inc.
  • France
      • La Tronche, France, 38700
        • Chu Grenoble
      • Lyon, France, 69003
        • Hopital Edouard Herriot - CHU Lyon
      • Nimes, France, 30029
        • CHU Nimes Hopital Caremeau
  • Japan
      • Date-gun, Japan, 969-1793
        • Fujita Health University Hospital
      • Kiyosu-shi, Japan, 452-0001
        • Hanasaki Clinic
      • Shiogama, Japan, 985-8506
        • Miyagikoseikyokai Saka General Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 7441
        • Hallym University Kangnam Sacred Heart Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Klinik Kesihatan Putrajaya Presint 9
      • Kuang, Malaysia, 48050
        • Klinik Kesihatan Kuang
      • Masjid Tanah, Malaysia, 78300
        • Klinik Kesihatan Masjid Tanah
      • Miri, Malaysia, 98000
        • Hospital Miri
  • Poland
      • Bialystok, Poland, 15-430
        • Gabinet Lekarski Pediatryczno-Alergologiczny
      • Katowice, Poland, 40 752
        • NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
      • Lodz, Poland, 90 302
        • ETG Lodz
      • Poznan, Poland, 60 309
        • EMC Instytut Medyczny SA PL CERTUS
      • Wroclaw, Poland, 53 021
        • NZOZ Leczniczo Rehabilitacyjny Osrodek Medycyny Rodzinnej
  • Spain
      • Algeciras, Spain, 11202
        • Cs Algeciras Norte
      • Alicante, Spain, 3010
        • Hosp. Gral. Univ. de Alicante
      • Barcelona, Spain, 08025
        • EAP Sardenya
      • Caldes Montbui Canovelles, Spain, 3308140
        • Cap Apenins - Montigala
      • Canet de Mar, Spain, 08360
        • Cap Canet de Mar
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • New Taipei, Taiwan, 23561
        • Taipei Medical University Shuang Ho Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 116
        • Taipei Municipal Wanfang Hospital
      • Taipei City, Taiwan, 110
        • Taipei Medical University
  • United Kingdom
      • Wirral, United Kingdom, CH49 5PE
        • The Adam Practice
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Central Alabama Research
      • Guntersville, Alabama, United States, 35976
        • Lakeview Clinical Research
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Synexus Clinical Research US Inc
      • Phoenix, Arizona, United States, 85044
        • Fiel Family and Sports Medicine Clinical Research Advantage
    • Arkansas
      • Harrisburg, Arkansas, United States, 72432
        • Harrisburg Family Medical Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida, Incorporated
      • Hialeah, Florida, United States, 33012
        • New Life Medical Research Center, Inc.
      • Hialeah, Florida, United States, 33016
        • Best Quality Research Inc
      • Medley, Florida, United States, 33166
        • PharmaDUX Clinical Medical Research, LLC
      • Miami, Florida, United States, 33173
        • Research Institute of South Florida Inc
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research,Inc
      • Miami, Florida, United States, 33165
        • Alma Clinical Research
      • Pembroke Pines, Florida, United States, 33024
        • Pines Care Research Center Inc
      • Tampa, Florida, United States, 33615
        • Santos Research Center
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Rincon, Georgia, United States, 31326
        • IACT Health
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Montana
      • Missoula, Montana, United States, 59808
        • Montana Medical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
      • Las Vegas, Nevada, United States, 89102
        • Healor Primary Care
      • Las Vegas, Nevada, United States, 89119
        • Santa Rosa Medical Centers of Nevada
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Bronx, New York, United States, 10465
        • Urgent Care Clinical Trials at AFC Urgent Care
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • American Health Network, LLC
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Akron, Ohio, United States, 44313
        • DayStar Clinical Research, Inc.
    • South Carolina
      • Easley, South Carolina, United States, 29640
        • Urgent Care Clinical Trials at AFC Urgent Care
    • Texas
      • Carrollton, Texas, United States, 75010
        • Premier Family Physicians
      • Corpus Christi, Texas, United States, 78411
        • Next Level Urgent Care
      • Dallas, Texas, United States, 75235
        • Southwest Family Medicine Associates
      • Fort Worth, Texas, United States, 76107
        • Urgent Care Clinical Trials Fort Worth
      • Houston, Texas, United States, 77081
        • Southwest Clinical Trials
      • Magnolia, Texas, United States, 77354
        • Renovatio Clinical
      • San Angelo, Texas, United States, 76904
        • Benchmark Research
    • Utah
      • Holladay, Utah, United States, 84117
        • CCT Research at Olympus Family Medicine
      • Ogden, Utah, United States, 84405
        • CCT Research at South Ogden Family Medicine
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Clinical Research Partners, LLC
      • Suffolk, Virginia, United States, 23435
        • IACT Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Participants with Acute Respiratory Infections (ARI) in Outpatient Setting
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.
Diagnostic test: Nasal Swab Sample
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
Time Frame: Day 1
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Day 1
Percentage of Participants Positive for Influenza Virus
Time Frame: Day 1
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Day 1
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Time Frame: Day 1
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Day 1
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
Time Frame: Up to 3 months
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.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
Time Frame: Up to 3 months
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.
Up to 3 months
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
Time Frame: Up to 3 months
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
Up to 3 months
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
Time Frame: Up to 3 months
Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
Up to 3 months
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
Time Frame: Up to 3 months
Percentage of participants positive for influenza virus reporting ARI-related hospitalizations during the study period will be reported.
Up to 3 months
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
Time Frame: Up to 3 months
Percentage of participants positive for SARS-CoV-2 reporting ARI-related hospitalizations during the study period will be reported.
Up to 3 months
Time to ARI- related Hospitalization in Participants Positive for RSV
Time Frame: Up to 3 months
Time to ARI- related hospitalization in participants positive for RSV will be reported.
Up to 3 months
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
Time Frame: Up to 3 months
Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
Up to 3 months
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
Time Frame: Up to 3 months
Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
Up to 3 months
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
Time Frame: Day 1
Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
Day 1
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
Time Frame: Up to 3 months
Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
Up to 3 months
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
Time Frame: Up to 3 months
Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
Up to 3 months
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
Time Frame: Up to 3 months
Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
Up to 3 months
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
Time Frame: Up to 3 months
Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
Up to 3 months
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
Time Frame: Day 1
Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
Day 1
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
Time Frame: Up to 3 months
Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
Up to 3 months
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
Time Frame: Up to 3 months
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
Up to 3 months
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
Time Frame: Up to 3 months
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
Up to 3 months
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
Time Frame: Up to 3 months
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR109104
  • NOPRODRSV4002 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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