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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05148780




Registration number
NCT05148780
Ethics application status
Date submitted
25/11/2021
Date registered
8/12/2021
Date last updated
18/08/2023

Titles & IDs
Public title
A Study of Acute Respiratory Infections in Global Outpatient Setting
Scientific title
Acute Respiratory Infections Global Outpatient Study
Secondary ID [1] 0 0
NOPRODRSV4002
Secondary ID [2] 0 0
CR109104
Universal Trial Number (UTN)
Trial acronym
ARGOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Nasal Swab Sample

Other: Participants with Acute Respiratory Infections (ARI) in Outpatient Setting - Participants 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.


Diagnosis / Prognosis: 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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Positive for Respiratory Syncytial Virus (RSV)
Timepoint [1] 0 0
Day 1
Primary outcome [2] 0 0
Percentage of Participants Positive for Influenza Virus
Timepoint [2] 0 0
Day 1
Primary outcome [3] 0 0
Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Timepoint [3] 0 0
Day 1
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 3 months
Secondary outcome [1] 0 0
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD
Timepoint [1] 0 0
Up to 3 months
Secondary outcome [2] 0 0
Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD
Timepoint [2] 0 0
Up to 3 months
Secondary outcome [3] 0 0
Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period
Timepoint [3] 0 0
Up to 3 months
Secondary outcome [4] 0 0
Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period
Timepoint [4] 0 0
Up to 3 months
Secondary outcome [5] 0 0
Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period
Timepoint [5] 0 0
Up to 3 months
Secondary outcome [6] 0 0
Time to ARI- related Hospitalization in Participants Positive for RSV
Timepoint [6] 0 0
Up to 3 months
Secondary outcome [7] 0 0
Time to ARI- related Hospitalization in Participants Positive for Influenza Virus
Timepoint [7] 0 0
Up to 3 months
Secondary outcome [8] 0 0
Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2
Timepoint [8] 0 0
Up to 3 months
Secondary outcome [9] 0 0
Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD
Timepoint [10] 0 0
Up to 3 months
Secondary outcome [11] 0 0
Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV
Timepoint [11] 0 0
Up to 3 months
Secondary outcome [12] 0 0
Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus
Timepoint [12] 0 0
Up to 3 months
Secondary outcome [13] 0 0
Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2
Timepoint [13] 0 0
Up to 3 months
Secondary outcome [14] 0 0
Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD
Timepoint [14] 0 0
Day 1
Secondary outcome [15] 0 0
Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD
Timepoint [15] 0 0
Up to 3 months
Secondary outcome [16] 0 0
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV
Timepoint [16] 0 0
Up to 3 months
Secondary outcome [17] 0 0
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus
Timepoint [17] 0 0
Up to 3 months
Secondary outcome [18] 0 0
Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2
Timepoint [18] 0 0
Up to 3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2023
Sample size
Target
Accrual to date
Final
234
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
Edmonton
Country [18] 0 0
France
State/province [18] 0 0
La Tronche
Country [19] 0 0
France
State/province [19] 0 0
Lyon
Country [20] 0 0
France
State/province [20] 0 0
Nimes
Country [21] 0 0
Japan
State/province [21] 0 0
Date-gun
Country [22] 0 0
Japan
State/province [22] 0 0
Kiyosu-shi
Country [23] 0 0
Japan
State/province [23] 0 0
Shiogama
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Busan
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Gyeonggi-do
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Incheon
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Malaysia
State/province [28] 0 0
Kuala Lumpur
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kuang
Country [30] 0 0
Malaysia
State/province [30] 0 0
Masjid Tanah
Country [31] 0 0
Malaysia
State/province [31] 0 0
Miri
Country [32] 0 0
Poland
State/province [32] 0 0
Bialystok
Country [33] 0 0
Poland
State/province [33] 0 0
Katowice
Country [34] 0 0
Poland
State/province [34] 0 0
Lodz
Country [35] 0 0
Poland
State/province [35] 0 0
Poznan
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
Spain
State/province [37] 0 0
Algeciras
Country [38] 0 0
Spain
State/province [38] 0 0
Alicante
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Caldes Montbui Canovelles
Country [41] 0 0
Spain
State/province [41] 0 0
Canet de Mar
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Taiwan
State/province [43] 0 0
Kaohsiung
Country [44] 0 0
Taiwan
State/province [44] 0 0
New Taipei
Country [45] 0 0
Taiwan
State/province [45] 0 0
Taipei City
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taipei
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05148780
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05148780