A Study of Acute Respiratory Infections in Global Outpatient Setting
NCT ID: NCT05148780
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
245 participants
INTERVENTIONAL
2021-12-20
2023-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Synexus Clinical Research US Inc
Mesa, Arizona, United States
Fiel Family and Sports Medicine Clinical Research Advantage
Phoenix, Arizona, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States
Innovative Research of West Florida, Incorporated
Clearwater, Florida, United States
New Life Medical Research Center, Inc.
Hialeah, Florida, United States
Best Quality Research Inc
Hialeah, Florida, United States
PharmaDUX Clinical Medical Research, LLC
Medley, Florida, United States
Homestead Associates in Research,Inc
Miami, Florida, United States
Alma Clinical Research
Miami, Florida, United States
Research Institute of South Florida Inc
Miami, Florida, United States
Pines Care Research Center Inc
Pembroke Pines, Florida, United States
Santos Research Center
Tampa, Florida, United States
Columbus Regional Research Institute
Columbus, Georgia, United States
IACT Health
Rincon, Georgia, United States
Snake River Research, PLLC
Idaho Falls, Idaho, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Montana Medical Research
Missoula, Montana, 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
Urgent Care Clinical Trials at AFC Urgent Care
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
American Health Network, LLC
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
DayStar Clinical Research, Inc.
Akron, Ohio, United States
Urgent Care Clinical Trials at AFC Urgent Care
Easley, South Carolina, United States
Premier Family Physicians
Carrollton, Texas, United States
Next Level Urgent Care
Corpus Christi, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Urgent Care Clinical Trials Fort Worth
Fort Worth, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Renovatio Clinical
Magnolia, Texas, United States
Benchmark Research
San Angelo, Texas, United States
CCT Research at Olympus Family Medicine
Holladay, Utah, United States
CCT Research at South Ogden Family Medicine
Ogden, Utah, United States
Clinical Research Partners, LLC
Henrico, Virginia, United States
IACT Health
Suffolk, Virginia, United States
ALTA Clinical Research Inc.
Edmonton, Alberta, Canada
CHU Grenoble
La Tronche, , France
Hopital Edouard Herriot - CHU Lyon
Lyon, , France
CHU Nimes Hopital Caremeau
Nîmes, , France
Fujita Health University Hospital
Date-gun, , Japan
Hanasaki Clinic
Kiyosu-shi, , Japan
Miyagikoseikyokai Saka General Hospital
Shiogama, , Japan
Klinik Kesihatan Putrajaya Presint 9
Kuala Lumpur, , Malaysia
Klinik Kesihatan Kuang
Kuang, , Malaysia
Klinik Kesihatan Masjid Tanah
Masjid Tanah, , Malaysia
Hospital Miri
Miri, , Malaysia
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, , Poland
Inje University Busan Paik Hospital
Busan, , South Korea
Korea University Ansan Hospital
Gyeonggi-do, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
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, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
Taipei Medical University
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Taipei Municipal Wanfang Hospital
Taipei, , Taiwan
The Adam Practice
Metropolitan Borough of Wirral, , United Kingdom
Countries
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Other Identifiers
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NOPRODRSV4002
Identifier Type: OTHER
Identifier Source: secondary_id
CR109104
Identifier Type: -
Identifier Source: org_study_id
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