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Completed

NCT Number: NCT05148780

A Study of Acute Respiratory Infections in Global Outpatient Setting

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.

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Key information

Conditions

Acute Respiratory Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

ALTA Clinical Research Inc., Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Swab Sample

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  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

    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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Acute Respiratory Infections Global Outpatient Study

Acronym: ARGOS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 8, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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