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

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: Completed
• Conditions: Acute Respiratory Infection
• Intervention / Treatment: Diagnostic test: Nasal Swab Sample

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: Interventional
• Enrollment (Actual): 245
• Phase: Early Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	Day 1
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	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	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

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	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	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	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	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	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 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 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 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	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	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 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 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 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	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	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 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 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 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

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; Flu; Respiratory syncytial virus (RSV)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID 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