A Study of Acute Respiratory Infections in Global Outpatient Setting

NCT05148780 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: CR109104NOPRODRSV4002
• Study Type: interventional
• Target: 245
• Locations: 10 countries
• Sites: 72

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.

Conditions

Acute Respiratory Infection

Keywords

Respiratory syncytial virus (RSV); Flu; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (18)

• Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for Influenza Virus Diagnosed with or Without LRTD

  Up to 3 months

• Number of Participants with Relative Risk of ARI-related Hospitalization in Participants Positive for SARS-CoV-2 with or Without LRTD

  Up to 3 months

• Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period

  Up to 3 months

• Percentage of Participants Positive for Influenza Virus Reporting ARI-related Hospitalizations During the Study Period

  Up to 3 months

• Percentage of Participants Positive for SARS-CoV-2 Reporting ARI-related Hospitalizations During the Study Period

  Up to 3 months

Study Arms (1)

Participants with Acute Respiratory Infections (ARI) in Outpatient Setting

OTHER

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.

Diagnostic Test: Nasal Swab Sample

Interventions

Nasal Swab Sample DIAGNOSTIC_TEST

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.

Participants with Acute Respiratory Infections (ARI) in Outpatient Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (72)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

Location

Synexus Clinical Research US Inc

Mesa, Arizona, 85213, United States

Location

Fiel Family and Sports Medicine Clinical Research Advantage

Phoenix, Arizona, 85044, United States

Location

Harrisburg Family Medical Center

Harrisburg, Arkansas, 72432, United States

Location

Innovative Research of West Florida, Incorporated

Clearwater, Florida, 33756, United States

Location

New Life Medical Research Center, Inc.

Hialeah, Florida, 33012, United States

Location

Best Quality Research Inc

Hialeah, Florida, 33016, United States

Location

PharmaDUX Clinical Medical Research, LLC

Medley, Florida, 33166, United States

Location

Homestead Associates in Research,Inc

Miami, Florida, 33032, United States

Location

Alma Clinical Research

Miami, Florida, 33165, United States

Location

Research Institute of South Florida Inc

Miami, Florida, 33173, United States

Location

Pines Care Research Center Inc

Pembroke Pines, Florida, 33024, United States

Location

Santos Research Center

Tampa, Florida, 33615, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

IACT Health

Rincon, Georgia, 31326, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Montana Medical Research

Missoula, Montana, 59808, United States

Location

Healor Primary Care

Las Vegas, Nevada, 89102, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

Santa Rosa Medical Centers of Nevada

Las Vegas, Nevada, 89119, United States

Location

Urgent Care Clinical Trials at AFC Urgent Care

The Bronx, New York, 10465, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

American Health Network, LLC

Charlotte, North Carolina, 28207, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

DayStar Clinical Research, Inc.

Akron, Ohio, 44313, United States

Location

Urgent Care Clinical Trials at AFC Urgent Care

Easley, South Carolina, 29640, United States

Location

Premier Family Physicians

Carrollton, Texas, 75010, United States

Location

Next Level Urgent Care

Corpus Christi, Texas, 78411, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

Urgent Care Clinical Trials Fort Worth

Fort Worth, Texas, 76107, United States

Location

Southwest Clinical Trials

Houston, Texas, 77081, United States

Location

Renovatio Clinical

Magnolia, Texas, 77354, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

CCT Research at Olympus Family Medicine

Holladay, Utah, 84117, United States

Location

CCT Research at South Ogden Family Medicine

Ogden, Utah, 84405, United States

Location

Clinical Research Partners, LLC

Henrico, Virginia, 23233, United States

Location

IACT Health

Suffolk, Virginia, 23435, United States

Location

ALTA Clinical Research Inc.

Edmonton, Alberta, T5A 4L8, Canada

Location

CHU Grenoble

La Tronche, 38700, France

Location

Hopital Edouard Herriot - CHU Lyon

Lyon, 69003, France

Location

CHU Nimes Hopital Caremeau

Nîmes, 30029, France

Location

Fujita Health University Hospital

Date-gun, 969-1793, Japan

Location

Hanasaki Clinic

Kiyosu-shi, 452-0001, Japan

Location

Miyagikoseikyokai Saka General Hospital

Shiogama, 985-8506, Japan

Location

Klinik Kesihatan Putrajaya Presint 9

Kuala Lumpur, 50400, Malaysia

Location

Klinik Kesihatan Kuang

Kuang, 48050, Malaysia

Location

Klinik Kesihatan Masjid Tanah

Masjid Tanah, 78300, Malaysia

Location

Hospital Miri

Miri, 98000, Malaysia

Location

Gabinet Lekarski Pediatryczno-Alergologiczny

Bialystok, 15-430, Poland

Location

NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna

Katowice, 40 752, Poland

Location

ETG Lodz

Lodz, 90 302, Poland

Location

EMC Instytut Medyczny SA PL CERTUS

Poznan, 60 309, Poland

Location

NZOZ Leczniczo Rehabilitacyjny Osrodek Medycyny Rodzinnej

Wroclaw, 53 021, Poland

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, 15355, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, 7441, South Korea

Location

Cs Algeciras Norte

Algeciras, 11202, Spain

Location

Hosp. Gral. Univ. de Alicante

Alicante, 3010, Spain

Location

Eap Sardenya

Barcelona, 08025, Spain

Location

Cap Apenins - Montigala

Caldes Montbui Canovelles, 3308140, Spain

Location

Cap Canet de Mar

Canet de Mar, 08360, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Taipei Medical University

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

Location

The Adam Practice

Metropolitan Borough of Wirral, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human; COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: December 20, 2021
• Primary Completion: February 20, 2023
• Study Completion: February 22, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); CA (1); US (39); MY (4); JP (3); KR (4); ES (6); GB (1); TW (6); PL (5)