ARGOS: A Study of Acute Respiratory Infections in Global Outpatient Setting
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Diagnostic Test: 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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Positive for Respiratory Syncytial Virus (RSV) [Day 1]
Percentage of participants positive for RSV, among those screened for viral pathogens using a polymerase chain reaction (PCR)-based test will be reported.
- Percentage of Participants Positive for Influenza Virus [Day 1]
Percentage of participants positive for influenza virus, among those screened for viral pathogens using a PCR-based test will be reported.
- Percentage of Participants Positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) [Day 1]
Percentage of participants positive for SARS-CoV-2, among those screened for viral pathogens using a PCR- based test will be reported
- 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 [Up to 3 months]
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.
Secondary Outcome Measures
- 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 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.
- 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]
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
- Percentage of Participants Positive for RSV Reporting ARI-related Hospitalizations During the Study Period [Up to 3 months]
Percentage of participants positive for RSV reporting ARI-related hospitalizations during the study period will be reported.
- Percentage of Participants Positive for Influenza Virus 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 will be reported.
- Percentage of Participants Positive for SARS-CoV-2 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 will be reported.
- Time to ARI- related Hospitalization in Participants Positive for RSV [Up to 3 months]
Time to ARI- related hospitalization in participants positive for RSV will be reported.
- Time to ARI- related Hospitalization in Participants Positive for Influenza Virus [Up to 3 months]
Time to ARI- related hospitalization in participants positive for influenza virus will be reported.
- Time to ARI- related Hospitalization in Participants Positive for SARS-CoV-2 [Up to 3 months]
Time to ARI- related hospitalization in participants positive for SARS-CoV-2 will be reported.
- Percentage of Participants Presenting with Complications at Screening and Diagnosed with or Without LRTD [Day 1]
Percentage of participants presenting with complications at screening and diagnosed with or without LRTD will be reported.
- Percentage of Participants Reporting ARI- related Complications During the Follow-up Period and Diagnosed with or Without LRTD [Up to 3 months]
Percentage of participants reporting ARI- related complications during the follow-up period and diagnosed with or without LRTD will be reported.
- Time to ARI- related Complications During the Follow-up Period in Participants Positive for RSV [Up to 3 months]
Time to ARI- related complications during the follow-up period in participants positive for RSV will be reported.
- Time to ARI- related Complications During the Follow-up Period in Participants Positive for Influenza Virus [Up to 3 months]
Time to ARI- related complications during the follow-up period in participants positive for influenza virus will be reported.
- Time to ARI- related Complications During the Follow-up Period in Participants Positive for SARS-CoV-2 [Up to 3 months]
Time to ARI- related complications during the follow-up period in participants positive for SARS-CoV-2 will be reported
- Percentage of Participants Presenting with Clinically Relevant Disease at Screening and Diagnosed with or Without LRTD [Day 1]
Percentage of participants presenting with clinically relevant disease at screening and diagnosed with or without LRTD will be reported.
- Percentage of Participants Reporting ARI- related Clinically Relevant Disease During the Follow-up Period and Diagnosed with or Without LRTD [Up to 3 months]
Percentage of participants reporting ARI-related clinically relevant disease during the follow-up period and diagnosed with or without LRTD will be reported.
- Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for RSV [Up to 3 months]
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for RSV will be reported.
- Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for Influenza Virus [Up to 3 months]
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for influenza virus will be reported.
- Time to ARI-related Clinically Relevant Disease During the Follow-up Period in Participants Positive for SARS-CoV-2 [Up to 3 months]
Time to ARI-related clinically relevant disease during the follow-up period in participants positive for SARS-CoV-2 will be reported.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Alabama Research | Birmingham | Alabama | United States | 35209 |
| 2 | Lakeview Clinical Research | Guntersville | Alabama | United States | 35976 |
| 3 | Synexus Clinical Research US, Inc | Glendale | Arizona | United States | 85308 |
| 4 | Synexus Clinical Research US, Inc | Mesa | Arizona | United States | 85213 |
| 5 | Fiel Family and Sports Medicine Clinical Research Advantage | Phoenix | Arizona | United States | 85044 |
| 6 | Harrisburg Family Medical Center | Harrisburg | Arkansas | United States | 72432 |
| 7 | Hope clinical Research LLC | Canoga Park | California | United States | 91303 |
| 8 | Ark Clinical Research | Long Beach | California | United States | 90806 |
| 9 | VA Sacramento Medical Center | Mather | California | United States | 95655 |
| 10 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 11 | Innovative Research of West Florida, Incorporated | Clearwater | Florida | United States | 33756 |
| 12 | New Life Medical Research Center, Inc. | Hialeah | Florida | United States | 33012 |
| 13 | Best Quality Research Inc | Hialeah | Florida | United States | 33016 |
| 14 | Care Partners Clinical Research | Jacksonville | Florida | United States | 32277 |
| 15 | Homestead Associates in Research,Inc | Miami | Florida | United States | 33032 |
| 16 | South Florida Research Center Inc. | Miami | Florida | United States | 33135 |
| 17 | Alma Clinical Research | Miami | Florida | United States | 33165 |
| 18 | Advanced Medical Research Institute | Miami | Florida | United States | 33173 |
| 19 | Research Institute of South Florida Inc | Miami | Florida | United States | 33173 |
| 20 | Pines Care Research Center Inc | Pembroke Pines | Florida | United States | 33024 |
| 21 | Santos Research Center | Tampa | Florida | United States | 33615 |
| 22 | Columbus Regional Research Institute | Columbus | Georgia | United States | 31904 |
| 23 | Srilatha Edupuganti NIAID | Decatur | Georgia | United States | 30033 |
| 24 | IACT Health | Rincon | Georgia | United States | 31326 |
| 25 | Snake River Research, PLLC | Idaho Falls | Idaho | United States | 83404 |
| 26 | American Health Network of Indiana, LLC | Avon | Indiana | United States | 46123 |
| 27 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 28 | Montana Medical Research | Missoula | Montana | United States | 59808 |
| 29 | Healor Primary Care | Las Vegas | Nevada | United States | 89102 |
| 30 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
| 31 | Las Vegas Medical Research | Las Vegas | Nevada | United States | 89113 |
| 32 | Santa Rosa Medical Centers of Nevada | Las Vegas | Nevada | United States | 89119 |
| 33 | VA Sierra Nevada Health Care System | Reno | Nevada | United States | 89509 |
| 34 | Urgent Care Clinical Trials at AFC Urgent Care | Bronx | New York | United States | 10465 |
| 35 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
| 36 | SUNY Downstate Medical Center | Brooklyn | New York | United States | 11203 |
| 37 | Kernodle Clinic | Burlington | North Carolina | United States | 27215 |
| 38 | American Health Network, LLC | Charlotte | North Carolina | United States | 28207 |
| 39 | Wake Forest Baptist Health Urgent Care Clemmons | Clemmons | North Carolina | United States | 27103 |
| 40 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 41 | Javara | Matthews | North Carolina | United States | 28105 |
| 42 | Burke Primary Care | Morganton | North Carolina | United States | 28655 |
| 43 | DayStar Clinical Research, Inc. | Akron | Ohio | United States | 44313 |
| 44 | Lynn Institute of Norman | Norman | Oklahoma | United States | 73072 |
| 45 | Ascension Medical Group - St. John Clinic Infectious Disease | Tulsa | Oklahoma | United States | 74104 |
| 46 | East Liberty Family Healthcare Center | Pittsburgh | Pennsylvania | United States | 15206 |
| 47 | Urgent Care Clinical Trials at AFC Urgent Care | Easley | South Carolina | United States | 29640 |
| 48 | Nashville VA Medical Center | Nashville | Tennessee | United States | 37209 |
| 49 | Premier Family Physicians | Carrollton | Texas | United States | 75010 |
| 50 | Next Level Urgent Care | Corpus Christi | Texas | United States | 78411 |
| 51 | Southwest Family Medicine Associates | Dallas | Texas | United States | 75235 |
| 52 | Urgent Care Clinical Trials Fort Worth | Fort Worth | Texas | United States | 76107 |
| 53 | Accurate Clinical Management, LLC | Houston | Texas | United States | 77065 |
| 54 | Southwest Clinical Trials | Houston | Texas | United States | 77081 |
| 55 | FMC Science | Lampasas | Texas | United States | 76550 |
| 56 | Renovatio Clinical | Magnolia | Texas | United States | 77354 |
| 57 | SMS Clinical Research LLC | Mesquite | Texas | United States | 75149 |
| 58 | Benchmark Research | San Angelo | Texas | United States | 76904 |
| 59 | Intermountain Clinical Research | Draper | Utah | United States | 84020 |
| 60 | CCT Research at Olympus Family Medicine | Holladay | Utah | United States | 84117 |
| 61 | CCT Research at South Ogden Family Medicine | Ogden | Utah | United States | 84405 |
| 62 | Clinical Research Partners, LLC | Henrico | Virginia | United States | 23233 |
| 63 | IACT Health | Suffolk | Virginia | United States | 23435 |
| 64 | MultiCare Health Systems for Research and Innovation | Spokane | Washington | United States | 99204 |
| 65 | MultiCare Health System | Tacoma | Washington | United States | 98402 |
| 66 | Frontier Clinical Research | Morgantown | West Virginia | United States | 26505 |
| 67 | Hospital Aleman | Buenos Aires | Argentina | 1119 | |
| 68 | Sanatorio de la Trinidad Mitre | Ciudad Autonoma Buenos Aires | Argentina | C1039AAO | |
| 69 | Hospital General de Agudos Donacion Francisco Santojanni | Ciudad Autonoma de Buenos Aires | Argentina | C1408INH | |
| 70 | Hospital J. M. Ramos Mejía | Ciudad de Buenos Aires | Argentina | C1221Adc | |
| 71 | Sanatorio Allende | Cordoba | Argentina | 5000 | |
| 72 | Sanatorio Duarte Quiroz | Cordoba | Argentina | 5000 | |
| 73 | Instituto Médico DAMIC | Cordoba | Argentina | X5003DCE | |
| 74 | Hospital Español | La Plata | Argentina | 1900 | |
| 75 | Instituto Medico Platense | La Plata | Argentina | B1900Avg | |
| 76 | Clinica del Niño y la familia | Mar Del Plata | Argentina | 7600 | |
| 77 | Instituto Medico de La Fundacion Estudios Clinicos | Rosario | Argentina | 2000 | |
| 78 | Sanatorio Britanico S.A. | Rosario | Argentina | 2000 | |
| 79 | Hospital Municipal de Vicente Lopez Dr. Bernardo Houssay | San Isidro | Argentina | 1605 | |
| 80 | Investigaciones en Patologias Respiratorias | San Miguel de Tucumán | Argentina | 4000 | |
| 81 | Instituto Del Buen Aire | Santa Fe | Argentina | 3000 | |
| 82 | Blacktown Hospital | Blacktown | Australia | 2148 | |
| 83 | Monash Medical Centre | Clayton | Australia | 3168 | |
| 84 | Westmead Hospital | Westmead | Australia | 2145 | |
| 85 | Hospital Brasília | Brasília | Brazil | 71.681-603 | |
| 86 | Fundação Universidade Federal de Mato Grosso do Sul | Campo Grande | Brazil | 79.081-746 | |
| 87 | Hrpc Ulbratech - Ulbra | Canoas | Brazil | 92010-170 | |
| 88 | CMiP - Centro Mineiro de Pesquisa | Juiz de Fora | Brazil | 36010-570 | |
| 89 | Complexo Hospitalar de Niterói | Niteroi | Brazil | 24030-103 | |
| 90 | Instituto Mederi de Pesquisa e Saude | Passo Fundo | Brazil | 99010-080 | |
| 91 | Hospital de Clínicas de Porto Alegre | Porto Alegre | Brazil | 90035-903 | |
| 92 | Instituto de infectologia Emilio Ribas | Sao Paulo | Brazil | 01246-900 | |
| 93 | CMPC - Consultoria Médica e Pesquisa Clínica | Sorocaba | Brazil | 18040-425 | |
| 94 | Hospital Nove de Julho | São Paulo | Brazil | 01409902 | |
| 95 | Bluewater Clinical Research Group Inc. | Sarnia | Ontario | Canada | N7T 4X3 |
| 96 | Deshinee Moodley Meidicine Professional Corporation | Windsor | Ontario | Canada | |
| 97 | ALTA Clinical Research Inc. | Edmonton | Canada | T5A 4L8 | |
| 98 | Albion Finch Medical Centre | Toronto | Canada | M9V 4B4 | |
| 99 | Xiangya Hospital, Central South University | Changsha | China | 410008 | |
| 100 | Changzhou No.2 People's Hospital | Changzhou | China | 213100 | |
| 101 | The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | China | 310009 | |
| 102 | Inner Mongolia People's Hospital | Huhehaote | China | 010017 | |
| 103 | Qianfoshan hospital of Shandong Province | Jinan | China | 250014 | |
| 104 | Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University | Shanghai | China | 200025 | |
| 105 | Shanghai Zhongshan Hospital | Shanghai | China | 200032 | |
| 106 | ShangHai Huadong Hospital | Shanghai | China | 200040 | |
| 107 | Shanghai Tongren Hospital | Shanghai | China | 200050 | |
| 108 | Shanghai East Hospital | Shanghai | China | 200123 | |
| 109 | The Fifth People's Hospital of Shanghai, Fudan University | Shanghai | China | 200240 | |
| 110 | Shengjing Hospital of China Medical University | Shenyang | China | 110004 | |
| 111 | Hospital Universidad del Norte | Barranquilla | Colombia | 80020 | |
| 112 | Medplus Medicina Prepagada S.A. | Bogota | Colombia | 110111 | |
| 113 | Solano y Terront Servicios Médicos Ltda. | Bogota | Colombia | 110221 | |
| 114 | IPS Caja de Compensacion Familiar CAFAM | Bogota | Colombia | 111211 | |
| 115 | Centro Medico Imbanaco de Cali S.A. | Casanare | Colombia | 760042 | |
| 116 | Clínica Universitaria de la Sabana | Chia | Colombia | 1101 | |
| 117 | Fundacion Oftalmologica de Santander - FOSCAL | Floridablanca | Colombia | 681004 | |
| 118 | Programa de Estudio y Control de Enfermedades Tropicales | Medellin | Colombia | 050010 | |
| 119 | Funcentra | Monteria, Cordoba | Colombia | ||
| 120 | CHU Amiens - Hopital Sud | AMIENS cedex 1 | France | 80000 | |
| 121 | Hopital Henri Mondor | Creteil | France | 94000 | |
| 122 | Centre Hospitalier Départemental | La Roche S/ Yon Cedex 9 | France | 85925 | |
| 123 | Centre Hospitalier Départmental La Roche sur Yon | La Roche sur Yon Cedex 9 | France | 85000 | |
| 124 | CHU Grenoble | La Tronche | France | 38700 | |
| 125 | CHU de Limoges, Hopital Dupuytren | Limoges | France | 87042 | |
| 126 | Hopital Edouard Herriot - CHU Lyon | Lyon | France | 69003 | |
| 127 | Hopital Edouard Herriot - CHU Lyon | Lyon | France | 69003 | |
| 128 | Maison Medicale Rive Sud | Murs Erigne | France | 49610 | |
| 129 | CHU Nantes - Hotel Dieu | Nantes Cedex 1 | France | 44093 | |
| 130 | CHU Nimes - Hôpital Carémeau | Nimes | France | 30029 | |
| 131 | Hôpital Bichat - Claude Bernard | Paris | France | 75018 | |
| 132 | Hôpital Bichat - Claude Bernard | Paris | France | 75018 | |
| 133 | Hospices Civils de Lyon HCL | Pierre-Bénite | France | 69495 | |
| 134 | CHU Tours - Hopital Bretonneau - Maladies Infectieuses | Tours | France | 37044 | |
| 135 | CHU Tours - Hopital Bretonneau - Maladies Infectieuses | Tours | France | 37044 | |
| 136 | Berliner Centrum f. Reise- und Tropenmedizin (BCRT) | Berlin | Germany | 10117 | |
| 137 | Charite Universitaetsmedizin Berlin - Campus Charite Mitte | Berlin | Germany | 10117 | |
| 138 | Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH | Berlin | Germany | 10439 | |
| 139 | EPIMED GmbH | Berlin | Germany | 10787 | |
| 140 | MuM Medizin und Mehr eG | Buende | Germany | 32257 | |
| 141 | Praxis Dr. Keller | Frankfurt | Germany | 60389 | |
| 142 | IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum | Frankfurt | Germany | 60596 | |
| 143 | medicoKIT GmbH | Goch | Germany | 47574 | |
| 144 | Clinical Research HamburggmbH | Hamburg | Germany | 22143 | |
| 145 | Universitaetsklinikum Koeln | Köln | Germany | 50937 | |
| 146 | Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut | Leipzig | Germany | 04249 | |
| 147 | Universitaetsklinikum Schleswig-Holstein - Campus Luebeck | Luebeck | Germany | 23538 | |
| 148 | Universitaetsmedizin Rostock | Rostock | Germany | 18057 | |
| 149 | Gemeinschaftspraxis | Wallerfing | Germany | 94574 | |
| 150 | Nucleo di Cure Primarie della Val Pescara | Alanno | Italy | 65020 | |
| 151 | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) | Bergamo | Italy | 24127 | |
| 152 | Ospedale Policlinico San Martino IRCCS | Genova | Italy | 16132 | |
| 153 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | 20122 | |
| 154 | Ospedale San Raffaele | Milano | Italy | 20127 | |
| 155 | Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | 27100 | |
| 156 | Azienda Sanitaria Locale N. 2 Savonese - Presidio ospedaliero di Albenga - Ospedale Santa Corona | Pietra Ligure | Italy | 17027 | |
| 157 | Istituto Clinico Humanitas | Rozzano | Italy | 20089 | |
| 158 | Fujita Health University Hospital | Date-gun | Japan | 969-1793 | |
| 159 | Fukuoka University Hospital | Fukuoka | Japan | 814-0180 | |
| 160 | Hiroshima Prefectural Hospital | Hiroshima-shi | Japan | 734-8530 | |
| 161 | Hanasaki Clinic | Kiyosu-shi | Japan | 452-0001 | |
| 162 | Kurashiki Central Hospital | Kurashiki | Japan | 710-8602 | |
| 163 | National Hospital Organization Kyoto Medical Center | Kyoto | Japan | 612-8555 | |
| 164 | Shinrakuen Hospital | Niigata | Japan | 950-2087 | |
| 165 | Miyagikoseikyokai Saka General Hospital | Shiogama | Japan | 985-8506 | |
| 166 | Yamagata Prefectural Central Hospital | Yamagata-shi | Japan | 990-2292 | |
| 167 | Inje University Busan Paik Hospital | Busan | Korea, Republic of | 47392 | |
| 168 | Korea University Ansan Hospital | Gyeonggi-do | Korea, Republic of | 15355 | |
| 169 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 21565 | |
| 170 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
| 171 | Hallym University Kangnam Sacred Heart Hospital | Seoul | Korea, Republic of | 7441 | |
| 172 | Klinik Kesihatan Putrajaya Presint 9 | Kuala Lumpur | Malaysia | 50400 | |
| 173 | Hospital Sultanah Nur Zahirah | Kuala | Malaysia | 20400 | |
| 174 | Klinik Kesihatan Kuang | Kuang | Malaysia | 48050 | |
| 175 | Klinik Kesihatan Masjid Tanah | Masjid Tanah | Malaysia | 78300 | |
| 176 | Hospital Miri | Miri | Malaysia | 98000 | |
| 177 | CIAME | Cancun | Mexico | 70500 | |
| 178 | Hospital CIMA Chihuahua | Chihuahua | Mexico | 31238 | |
| 179 | Centro de Investigación Clínica Gramel S.C. | Ciudad de Mexico | Mexico | 3720 | |
| 180 | CEMDEC SA de CV | Ciudad de México | Mexico | 06100 | |
| 181 | Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA | Guadalajara | Mexico | 44130 | |
| 182 | Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán | Mexico City | Mexico | 14000 | |
| 183 | Instituto Nacional de Enfermedades Respiratorias | Mexico | Mexico | 14080 | |
| 184 | Hospital Metropolitano | Mexico | Mexico | 66480 | |
| 185 | Centro de Investigacion y Transferencia en Salud, Fundacion Santos y de la Garza Evia, IBP | Monterrey | Mexico | 64710 | |
| 186 | Oaxaca Site Management Organization S.C. | Oaxaca | Mexico | 68000 | |
| 187 | Unidad de Proyectos Clínicos de Oriente UPCO | Valladolid | Mexico | CP97780 | |
| 188 | Hospital General de Occidente | Zapopan | Mexico | 45170 | |
| 189 | Gabinet Lekarski Pediatryczno-Alergologiczny | Bialystok | Poland | 15-430 | |
| 190 | NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna | Katowice | Poland | 40-752 | |
| 191 | ETG Lodz | Lodz | Poland | 90-302 | |
| 192 | Centrum Innowacyjnych Terapii Sp. z o.o. | Piaseczno | Poland | 05-500 | |
| 193 | EMC Instytut Medyczny SA PL CERTUS | Poznan | Poland | 60-309 | |
| 194 | Gabinet Pulmonologii i Diagnostyki Chorob Alergicznych | Szczecin | Poland | 71-124 | |
| 195 | NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska | Wroclaw | Poland | 51-162 | |
| 196 | NZOZ Leczniczo-Rehabilitacyjny Ośrodek Medycyny Rodzinnej | Wrocław | Poland | 53-021 | |
| 197 | Cs Algeciras Norte | Algeciras | Spain | 11202 | |
| 198 | Hosp. Gral. Univ. de Alicante | Alicante | Spain | 3010 | |
| 199 | Policlinica Barcelona | Barcelona | Spain | 08006 | |
| 200 | Hosp. Quiron Barcelona | Barcelona | Spain | 08023 | |
| 201 | Eap Sardenya | Barcelona | Spain | 08025 | |
| 202 | Hosp. Clinic I Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 203 | Cap Apenins - Montigala | Caldes Montbui Canovelles | Spain | 3308140 | |
| 204 | Cap Canet de Mar | Canet de Mar | Spain | 08360 | |
| 205 | Cap Centelles | Centelles | Spain | 08540 | |
| 206 | Hosp. Gral. Univ. de Elche | Elche | Spain | 3203 | |
| 207 | Hosp. Clinico San Carlos | Madrid | Spain | 28040 | |
| 208 | Hosp. Clinico Univ. de Valladolid | Valladolid | Spain | 47005 | |
| 209 | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | Taiwan | 80756 | |
| 210 | Taipei Medical University Shuang Ho Hospital | New Taipei | Taiwan | 23561 | |
| 211 | Taipei Medical University | Taipei City | Taiwan | 110 | |
| 212 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 | |
| 213 | Tri-Service General Hospital | Taipei | Taiwan | 11490 | |
| 214 | Taipei Municipal Wanfang Hospital | Taipei | Taiwan | 116 | |
| 215 | Siriraj Hospital | Bangkok | Thailand | 10700 | |
| 216 | Srinagarind Hospital | Khon Kaen | Thailand | 40002 | |
| 217 | Ormeau Clinical Trials Ltd | Belfast | United Kingdom | BT7 2EB | |
| 218 | West Walk Surgery | Bristol | United Kingdom | BS374AX | |
| 219 | Optimum Patient Care | Cambridge | United Kingdom | CB24 3BA | |
| 220 | Hathaway Medical Centre | Chippenham | United Kingdom | SN14 6GT | |
| 221 | Royal Devon and Exeter Hospital(Wonford) | Exeter | United Kingdom | EX2 5DW | |
| 222 | Mounts Bay Medical Ltd | Hayle | United Kingdom | TR27 5DT | |
| 223 | Holderness Health NHS | Hull | United Kingdom | HU12 0PF | |
| 224 | Leicester Royal Infirmary | Leicester | United Kingdom | ||
| 225 | Wentworth Medical Practice | London | United Kingdom | N3 1YL | |
| 226 | St George's Hospital | London | United Kingdom | SW17 0QT | |
| 227 | Central Manchester University Hospitals NHS Foundation Trust | Manchester | United Kingdom | M8 5RB | |
| 228 | Knowle House Surgery | Plymouth | United Kingdom | PL5 3JB | |
| 229 | Southampton General Hospital | Poole | United Kingdom | BH16 5PW | |
| 230 | Tieve Tara Medical Centre | Wakefield | United Kingdom | WF1 5RH | |
| 231 | Cowplain Family Practice | Waterlooville | United Kingdom | PO8 8DL | |
| 232 | Sheepcot Medical Centre | Watford | United Kingdom | WD25 0EA | |
| 233 | The Adam Practice | Wirral | United Kingdom | CH49 5PE |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109104
- NOPRODRSV4002