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.
Brief Title
A Study of Acute Respiratory Infections in Global Outpatient Setting
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Respiratory Infection
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Respiratory syncytial virus (RSV)
Flu
COVID-19
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05148780
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR109104
Overall Status
Completed
Phases
Early Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Acute Respiratory Infections Global Outpatient Study
Primary Outcomes
Outcome Description
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
Outcome Measure
Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
Outcome Time Frame
Day 1
Outcome Description
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
Outcome Measure
Percentage of Participants Positive for Influenza Virus
Outcome Time Frame
Day 1
Outcome Description
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
Outcome Measure
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Outcome Time Frame
Day 1
Outcome Description
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.
Outcome 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
Outcome Time Frame
Up to 3 months
Secondary Ids
Secondary Id
NOPRODRSV4002
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 3 months
Outcome Measure
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
Outcome Description
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
Outcome Time Frame
Up to 3 months
Outcome Measure
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
Outcome Description
Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
Outcome Description
Percentage of participants positive for influenza virus reporting ARI-related hospitalizations during the study period will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
Outcome Description
Percentage of participants positive for SARS-CoV-2 reporting ARI-related hospitalizations during the study period will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
Outcome Description
Time to ARI- related hospitalization in participants positive for RSV will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Hospitalization in Participants Positive for RSV
Outcome Description
Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
Outcome Description
Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
Outcome Description
Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
Outcome Time Frame
Day 1
Outcome Measure
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
Outcome Description
Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
Outcome Description
Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
Outcome Description
Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
Outcome Description
Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
Outcome Description
Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
Outcome Time Frame
Day 1
Outcome Measure
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
Outcome Description
Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
Outcome Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
Outcome Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
Outcome Description
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.
Outcome Time Frame
Up to 3 months
Outcome Measure
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Barry Zingman
Investigator Email
bzingman@montefiore.org
Investigator Phone
718-920-2647
Categories Mesh Debug
COVID-19 --- COVID-19
COVID-19 --- RESPIRATORY TRACT INFECTIONS
Lung --- RESPIRATORY TRACT INFECTIONS
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
COVID-19 --- PNEUMONIA, VIRAL
COVID-19 --- PNEUMONIA
Lung --- PNEUMONIA
COVID-19 --- CORONAVIRUS INFECTIONS
COVID-19 --- CORONAVIRIDAE INFECTIONS
COVID-19 --- NIDOVIRALES INFECTIONS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
MeSH Terms
INFLUENZA, HUMAN
COVID-19
RESPIRATORY TRACT INFECTIONS
INFECTIONS
ORTHOMYXOVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
VIRUS DISEASES
RESPIRATORY TRACT DISEASES
PNEUMONIA, VIRAL
PNEUMONIA
CORONAVIRUS INFECTIONS
CORONAVIRIDAE INFECTIONS
NIDOVIRALES INFECTIONS
LUNG DISEASES