A Study of Acute Respiratory Infections in Global Outpatient Setting

Acute Respiratory Infection Clinical Trial

— ARGOS  

Official title:

Acute Respiratory Infections Global Outpatient Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148780
• Other study ID #: CR109104
• Secondary ID: NOPRODRSV4002
• Status: Completed
• Phase: Early Phase 1
• Start date: December 20, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: August 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 evaluate the association between lower respiratory tract disease (LRTD) and ARI-related hospitalization in participants positive for RSV.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: February 22, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Canada	ALTA Clinical Research Inc.	Edmonton
France	CHU Grenoble	La Tronche
France	Hopital Edouard Herriot - CHU Lyon	Lyon
France	CHU Nimes - Hôpital Carémeau	Nimes
Japan	Fujita Health University Hospital	Date-gun
Japan	Hanasaki Clinic	Kiyosu-shi
Japan	Miyagikoseikyokai Saka General Hospital	Shiogama
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Korea University Ansan Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Malaysia	Klinik Kesihatan Putrajaya Presint 9	Kuala Lumpur
Malaysia	Klinik Kesihatan Kuang	Kuang
Malaysia	Klinik Kesihatan Masjid Tanah	Masjid Tanah
Malaysia	Hospital Miri	Miri
Poland	Gabinet Lekarski Pediatryczno-Alergologiczny	Bialystok
Poland	NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna	Katowice
Poland	ETG Lodz	Lodz
Poland	EMC Instytut Medyczny SA PL CERTUS	Poznan
Poland	NZOZ Leczniczo-Rehabilitacyjny Osrodek Medycyny Rodzinnej	Wroclaw
Spain	Cs Algeciras Norte	Algeciras
Spain	Hosp. Gral. Univ. de Alicante	Alicante
Spain	Eap Sardenya	Barcelona
Spain	Cap Apenins - Montigala	Caldes Montbui Canovelles
Spain	Cap Canet de Mar	Canet de Mar
Spain	Hosp. Clinico San Carlos	Madrid
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei
Taiwan	Taipei Municipal Wanfang Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Medical University	Taipei City
United Kingdom	The Adam Practice	Wirral
United States	DayStar Clinical Research, Inc.	Akron	Ohio
United States	Central Alabama Research	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Urgent Care Clinical Trials at AFC Urgent Care	Bronx	New York
United States	Premier Family Physicians	Carrollton	Texas
United States	American Health Network, LLC	Charlotte	North Carolina
United States	Innovative Research of West Florida, Incorporated	Clearwater	Florida
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Next Level Urgent Care	Corpus Christi	Texas
United States	Southwest Family Medicine Associates	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Urgent Care Clinical Trials at AFC Urgent Care	Easley	South Carolina
United States	Urgent Care Clinical Trials Fort Worth	Fort Worth	Texas
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	Clinical Research Partners, LLC	Henrico	Virginia
United States	Best Quality Research Inc	Hialeah	Florida
United States	New Life Medical Research Center, Inc.	Hialeah	Florida
United States	CCT Research at Olympus Family Medicine	Holladay	Utah
United States	Southwest Clinical Trials	Houston	Texas
United States	Snake River Research, PLLC	Idaho Falls	Idaho
United States	Healor Primary Care	Las Vegas	Nevada
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada	Las Vegas	Nevada
United States	Renovatio Clinical	Magnolia	Texas
United States	PharmaDUX Clinical Medical Research, LLC	Medley	Florida
United States	Synexus Clinical Research US, Inc	Mesa	Arizona
United States	Alma Clinical Research	Miami	Florida
United States	Homestead Associates in Research,Inc	Miami	Florida
United States	Research Institute of South Florida Inc	Miami	Florida
United States	Montana Medical Research	Missoula	Montana
United States	CCT Research at South Ogden Family Medicine	Ogden	Utah
United States	Pines Care Research Center Inc	Pembroke Pines	Florida
United States	Fiel Family and Sports Medicine Clinical Research Advantage	Phoenix	Arizona
United States	IACT Health	Rincon	Georgia
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Benchmark Research	San Angelo	Texas
United States	IACT Health	Suffolk	Virginia
United States	Santos Research Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada,  France,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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