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Acute Respiratory InfectionEarly Phase 1ARGOSNCT05148780

A Study of Acute Respiratory Infections in Global Outpatient Setting

A Early Phase 1 study testing Nasal Swab Sample in people with Acute Respiratory Infection, run by Janssen Research & Development, LLC at 72 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Infection
What is being tested?
Nasal Swab Sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
72 sitesin 10 countries
Study dates
20 Dec 2021to 22 Feb 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

72 sites in 10 countries.

72 sites in 10 countries

United States39 sites

  • DayStar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Premier Family Physicians

    Carrollton, Texas, 75010

  • American Health Network, LLC

    Charlotte, North Carolina, 28207

  • Innovative Research of West Florida, Incorporated

    Clearwater, Florida, 33756

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Next Level Urgent Care

    Corpus Christi, Texas, 78411

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Urgent Care Clinical Trials at AFC Urgent Care

    Easley, South Carolina, 29640

  • Urgent Care Clinical Trials Fort Worth

    Fort Worth, Texas, 76107

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • Harrisburg Family Medical Center

    Harrisburg, Arkansas, 72432

  • Clinical Research Partners, LLC

    Henrico, Virginia, 23233

  • New Life Medical Research Center, Inc.

    Hialeah, Florida, 33012

  • Best Quality Research Inc

    Hialeah, Florida, 33016

  • CCT Research at Olympus Family Medicine

    Holladay, Utah, 84117

  • Southwest Clinical Trials

    Houston, Texas, 77081

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • Healor Primary Care

    Las Vegas, Nevada, 89102

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Santa Rosa Medical Centers of Nevada

    Las Vegas, Nevada, 89119

  • Renovatio Clinical

    Magnolia, Texas, 77354

  • PharmaDUX Clinical Medical Research, LLC

    Medley, Florida, 33166

  • Synexus Clinical Research US Inc

    Mesa, Arizona, 85213

  • Homestead Associates in Research,Inc

    Miami, Florida, 33032

  • Alma Clinical Research

    Miami, Florida, 33165

  • Research Institute of South Florida Inc

    Miami, Florida, 33173

  • Montana Medical Research

    Missoula, Montana, 59808

  • CCT Research at South Ogden Family Medicine

    Ogden, Utah, 84405

  • Pines Care Research Center Inc

    Pembroke Pines, Florida, 33024

  • Fiel Family and Sports Medicine Clinical Research Advantage

    Phoenix, Arizona, 85044

  • IACT Health

    Rincon, Georgia, 31326

  • Benchmark Research

    San Angelo, Texas, 76904

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • IACT Health

    Suffolk, Virginia, 23435

  • Santos Research Center

    Tampa, Florida, 33615

  • Urgent Care Clinical Trials at AFC Urgent Care

    The Bronx, New York, 10465

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Spain6 sites

  • Cs Algeciras Norte

    Algeciras, 11202

  • Hosp. Gral. Univ. de Alicante

    Alicante, 3010

  • Eap Sardenya

    Barcelona, 08025

  • Cap Apenins - Montigala

    Caldes Montbui Canovelles, 3308140

  • Cap Canet de Mar

    Canet de Mar, 08360

  • Hosp. Clinico San Carlos

    Madrid, 28040

Other trials in Spain

Taiwan6 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Taipei Medical University

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Taipei Municipal Wanfang Hospital

    Taipei, 116

Other trials in Taiwan

Poland5 sites

  • Gabinet Lekarski Pediatryczno-Alergologiczny

    Bialystok, 15-430

  • NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

    Katowice, 40 752

  • ETG Lodz

    Lodz, 90 302

  • EMC Instytut Medyczny SA PL CERTUS

    Poznan, 60 309

  • NZOZ Leczniczo Rehabilitacyjny Osrodek Medycyny Rodzinnej

    Wroclaw, 53 021

Other trials in Poland

Malaysia4 sites

  • Klinik Kesihatan Putrajaya Presint 9

    Kuala Lumpur, 50400

  • Klinik Kesihatan Kuang

    Kuang, 48050

  • Klinik Kesihatan Masjid Tanah

    Masjid Tanah, 78300

  • Hospital Miri

    Miri, 98000

Other trials in Malaysia

South Korea4 sites

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 7441

Other trials in South Korea

France3 sites

  • CHU Grenoble

    La Tronche, 38700

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69003

  • CHU Nimes Hopital Caremeau

    Nîmes, 30029

Other trials in France

Japan3 sites

  • Fujita Health University Hospital

    Date-gun, 969-1793

  • Hanasaki Clinic

    Kiyosu-shi, 452-0001

  • Miyagikoseikyokai Saka General Hospital

    Shiogama, 985-8506

Other trials in Japan

Canada1 site

  • ALTA Clinical Research Inc.

    Edmonton, Alberta, T5A 4L8

Other trials in Canada

United Kingdom1 site

  • The Adam Practice

    Metropolitan Borough of Wirral, CH49 5PE

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Nasal Swab Sample
Keywords
Respiratory syncytial virus (RSV), Flu, COVID-19
Medical subject headings
Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal Swab SampleDiagnostic test

    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.

Study groups in NCT05148780
Study groupRoleWhat they receive
Participants with Acute Respiratory Infections (ARI) in Outpatient SettingOtherParticipants 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.
Receives: Diagnostic Test: Nasal Swab Sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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

    Measured: Day 1

  4. 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.

    Measured: Up to 3 months

Secondary outcomes (18)

  1. 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.

    Measured: Up to 3 months

  2. 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

    Measured: Up to 3 months

  3. 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.

    Measured: Up to 3 months

  4. 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.

    Measured: Up to 3 months

  5. 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.

    Measured: Up to 3 months

  6. Time to ARI- related Hospitalization in Participants Positive for RSV

    Time to ARI- related hospitalization in participants positive for RSV will be reported.

    Measured: Up to 3 months

  7. 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.

    Measured: Up to 3 months

  8. 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.

    Measured: Up to 3 months

  9. 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.

    Measured: Day 1

  10. 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.

    Measured: Up to 3 months

  11. 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.

    Measured: Up to 3 months

  12. 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.

    Measured: Up to 3 months

  13. 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

    Measured: Up to 3 months

  14. 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.

    Measured: Day 1

  15. 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.

    Measured: Up to 3 months

  16. 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.

    Measured: Up to 3 months

  17. 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.

    Measured: Up to 3 months

  18. 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.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2021
  2. Study start20 Dec 2021
  3. Primary completion20 Feb 2023
  4. Study completion22 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05148780
Sponsor's protocol ID
CR109104
Other IDs
NOPRODRSV4002
Acronym
ARGOS
Status last verified
Jan 2025
First submitted
25 Nov 2021
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nasal Swab Sample in people with Acute Respiratory Infection, run by Janssen Research & Development, LLC at 72 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Spain, Taiwan, Poland, Malaysia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Positive for Respiratory Syncytial Virus (RSV) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05148780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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