Clinical trial NCT05148780: A Study of Acute Respiratory Infections in Global Outpatient Setting
Official title: Acute Respiratory Infections Global Outpatient Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Respiratory Infection
Keywords: Respiratory syncytial virus (RSV)
Flu
COVID-19
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
timeFrame: Day 1
measure: Percentage of Participants Positive for Influenza Virus
timeFrame: Day 1
measure: Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
timeFrame: Day 1
measure: 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
timeFrame: Up to 3 months
Secondary outcomes:
measure: Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
timeFrame: Up to 3 months
measure: Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
timeFrame: Up to 3 months
measure: Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
timeFrame: Up to 3 months
measure: Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
timeFrame: Up to 3 months
measure: Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
timeFrame: Up to 3 months
measure: Time to ARI- related Hospitalization in Participants Positive for RSV
timeFrame: Up to 3 months
measure: Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
timeFrame: Up to 3 months
measure: Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
timeFrame: Up to 3 months
measure: Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
timeFrame: Day 1
measure: Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
timeFrame: Up to 3 months
measure: Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
timeFrame: Up to 3 months
measure: Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
timeFrame: Up to 3 months
measure: Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
timeFrame: Up to 3 months
measure: Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
timeFrame: Day 1
measure: Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
timeFrame: Up to 3 months
measure: Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
timeFrame: Up to 3 months
measure: Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
timeFrame: Up to 3 months
measure: Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Mesa
country: United States
facility: Synexus Clinical Research US Inc
state: Arizona
city: Phoenix
country: United States
facility: Fiel Family and Sports Medicine Clinical Research Advantage
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Incorporated
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center, Inc.
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research Inc
state: Florida
city: Medley
country: United States
facility: PharmaDUX Clinical Medical Research, LLC
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research,Inc
state: Florida
city: Miami
country: United States
facility: Alma Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center Inc
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Rincon
country: United States
facility: IACT Health
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Las Vegas
country: United States
facility: Healor Primary Care
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada
state: Nevada
city: Bronx
country: United States
facility: Urgent Care Clinical Trials at AFC Urgent Care
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: American Health Network, LLC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Akron
country: United States
facility: DayStar Clinical Research, Inc.
state: Ohio
city: Easley
country: United States
facility: Urgent Care Clinical Trials at AFC Urgent Care
state: South Carolina
city: Carrollton
country: United States
facility: Premier Family Physicians
state: Texas
city: Corpus Christi
country: United States
facility: Next Level Urgent Care
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Fort Worth
country: United States
facility: Urgent Care Clinical Trials Fort Worth
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Magnolia
country: United States
facility: Renovatio Clinical
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Holladay
country: United States
facility: CCT Research at Olympus Family Medicine
state: Utah
city: Ogden
country: United States
facility: CCT Research at South Ogden Family Medicine
state: Utah
city: Henrico
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Suffolk
country: United States
facility: IACT Health
state: Virginia
city: Edmonton
country: Canada
facility: ALTA Clinical Research Inc.
state: Alberta
city: La Tronche
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hopital Edouard Herriot - CHU Lyon
city: Nimes
country: France
facility: CHU Nimes Hopital Caremeau
city: Date-gun
country: Japan
facility: Fujita Health University Hospital
city: Kiyosu-shi
country: Japan
facility: Hanasaki Clinic
city: Shiogama
country: Japan
facility: Miyagikoseikyokai Saka General Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Kuala Lumpur
country: Malaysia
facility: Klinik Kesihatan Putrajaya Presint 9
city: Kuang
country: Malaysia
facility: Klinik Kesihatan Kuang
city: Masjid Tanah
country: Malaysia
facility: Klinik Kesihatan Masjid Tanah
city: Miri
country: Malaysia
facility: Hospital Miri
city: Bialystok
country: Poland
facility: Gabinet Lekarski Pediatryczno-Alergologiczny
city: Katowice
country: Poland
facility: NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
city: Lodz
country: Poland
facility: ETG Lodz
city: Poznan
country: Poland
facility: EMC Instytut Medyczny SA PL CERTUS
city: Wroclaw
country: Poland
facility: NZOZ Leczniczo Rehabilitacyjny Osrodek Medycyny Rodzinnej
city: Algeciras
country: Spain
facility: Cs Algeciras Norte
city: Alicante
country: Spain
facility: Hosp. Gral. Univ. de Alicante
city: Barcelona
country: Spain
facility: Eap Sardenya
city: Caldes Montbui Canovelles
country: Spain
facility: Cap Apenins - Montigala
city: Canet de Mar
country: Spain
facility: Cap Canet de Mar
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung Ho Memorial Hospital
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Wirral
country: United Kingdom
facility: The Adam Practice
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: