Back to resultsA Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Primary Purpose
Influenza A
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimodivir 600 mg
Placebo
SOC Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Influenza A
Eligibility Criteria
Inclusion Criteria:
- Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
- Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
- Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
- Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours after onset of influenza symptoms
- Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease [presence of kidney damage for >3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests], or participants taking chronic systemic steroids)
Exclusion Criteria:
- Received more than (>)1 dose of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir >1 day prior to screening
- Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
- Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
- Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
- Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)
Sites / Locations
- University of Alabama at Birmingham
- Alabama Clinical Therapeutics, LLC
- Cahaba Research Inc
- Scottsboro Quick Care Clinic
- SC Clinical Research Inc.
- Research Center of Fresno Inc
- Allied Clinical Research
- Innovative Clinical Research, Inc.
- Om Research LLC
- Ark Clinical Research
- Miller Children's Hospital
- Downtown LA Research Center, Inc
- California Allergy & Asthma Medical Group Inc.
- Adam D. Karns, MD
- Lucita M. Cruz Md Inc
- Asclepes Research
- Center for Clinical Trials LLC
- Benchmark Research
- Medical Associates Research Group, Inc.
- San Diego Sports Medicine & Family Health Center
- West Coast Clinical Research, LLC
- Stanford University
- Lynn Institute
- Complete Family Care
- Paradigm Clinical Research Centers, Inc.
- Chase Medical Research, LLC
- Emerson Clinical Research Institute
- Moonshine Research Center, Inc
- Best Quality Research Inc
- Floridian Clinical Research, LLC
- The community Research of South Florida
- Encore Medical Research, LLC
- Homestead Associates in Research, Inc
- Care Partners Clinical Research
- Premier Medical Group
- Crystal Biomedical Research
- Sima Research Clinic
- Universal Clinical Research Associates
- South Florida Research Center Inc.
- A Plus Research
- Nuren Medical & Research Center
- Coral Research Clinic Corp
- New Horizon Research Center
- Vista Health Research, LLC
- Combined Research Orlando
- Clinical NeuroScience Solutions, Inc
- Omega Research Consultants
- Pines Care Research Center Inc
- South Broward Research, LLC
- Destin Pulmonary Critical Care, PLLS.
- Vita Health and Medical center
- Asclepes Research
- Axcess Medical Research, LLC
- Cozy Research, Llc
- Snake River Research, PLLC
- Saltzer Medical Group
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Investigators Research Group, LLC
- Medisphere Medical Research Center, Llc
- Hutchinson Clinic
- The Research Group of Lexington, LLC
- Clinical Trials Management, LLC
- Medpharmics, LLC
- North Star Clinical Research, LLC
- University Of Maryland Medical Center
- Johns Hopkins University School of Medicine
- Centennial Medical Group
- Massachusetts General Hospital
- Wayne State Univ School of Medicine
- Wayne State University
- William Beaumont Hospital
- Tri County Research, Inc.
- William Beaumont Hospital
- Arcturus Healthcare, PLC
- Craig A. Spiegel, MD
- Mercury Street Medical Group, PLLC
- Montana Medical Research
- Barrett Clinic P.C.
- Nebraska Medical Center
- Next Phase Research Alliance
- Saint Michael's Medical Center
- PMG Research
- Onsite Clinical Solutions
- Carolina Institute for Clinical Research
- clinical research of Gastonia
- Hickory Research Center.
- Monroe Biomedical Research
- Burke Primary Care
- PMG Research of Rocky Mount, LLC
- PMG Research of Wilmington, LLC
- Clinical Trials of America
- Southeastern Research Center LLC
- Dayton Clinical Research
- Buckeye Health and Research, LLC
- Lancaster General Hospital
- Detweiler Family Medicine and Associates
- Albert Einstein Healthcare Network
- Preferred Primary Care Physicians Research
- Frontier Clinical Research
- Preferred Primary Care Physicians Research
- AAPRI Clinical Research Institute
- Spectrum Medical Research
- DeGarmo Institute of Medical Research
- PMG Research of Charleston, LLC
- Fusion Clinical Research of Spartanburg
- Invocare Clinical Research Center
- Health Concepts
- PMG Research of Bristol
- PMG Research of Knoxville
- PMG Research of Knoxville
- HIRG, LLC dba Health Innovation Research Group
- ACRC Trials
- Family Medicine Associates of Texas
- University of Texas Southwestern Medical Center
- WR-Global Medical Research, LLC
- University Of Texas Medical Branch At Galveston
- San Gabriel Clinical Research, LLC
- BI Research Center
- West Houston Clinical Research Service
- Northwest Med Care,P.A.
- Southwest Clinical Trials
- Dairy Ashford Family Practice
- JM Research.PLLC
- PCP for Life
- SMS Clinical Research LLC
- Village Health Partners
- Tekton Research Inc.
- DM Clinical Research
- Renovatio Clinical
- ClinPoint Trials
- Val Hansen
- Ericksen Research and Development
- J. Lewis research Inc./ Foothill Family Clinic South
- Advanced Research Institute
- Granger Medical Clinic-Riverton
- J. Lewis research Inc./ Foothill Family Care
- J. Lewis research Inc./ Foothill Family Clinic South
- J. Lewis Research Inc/ FirstMed East
- J. Lewis Research Inc./Jordan River Family Medicine
- Millennium Clinical Trials, LLC
- Hospital Interzonal General de Agudos Dr. Jose Penna
- CEMIC Saavedra
- Hospital Nuestra Señora de la Misericordia
- Sanatorio Allende
- Hospital Cordoba
- Hospital Privado Centro Medico de Cordoba
- Hospital Rawson
- Hospital San Roque
- Sanatorio Juan XXIII
- Sanatorio del Oeste Ituzaingo
- Hospital Italiano de La Plata
- Instituto Medico Platense
- Sanatorio Britanico S.A.
- Instituto Del Buen Aire
- Northside Health
- Mater Hospital Brisbane
- AKH - Medizinische Universität Wien
- SMZ Süd - Kaiser Franz Josef Spital Wien
- Hopital Erasme
- CHU Saint-Pierre
- Institut Jules Bordet
- De Meulemeester, Marc
- Jaak Mortelmans
- Quartier du Furgy 4
- Research Link
- BVBA Dr. Luc Capiau
- Testumed
- Santa Casa de Misericordia de Belo Horizonte
- Infection Control Ltda
- Hrpc Ulbratech - Ulbra
- Centro de Estudos Clínicos do Interior Paulista - CECIP
- CMiP - Centro Mineiro de Pesquisa
- Hospital Sao Vicente de Paulo
- Hospital de Clínicas de Porto Alegre
- Hospital São Lucas da PUCRS
- CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
- Pesquisare Saude
- CEMEC - Centro Multidisciplinar de Estudos Clínicos
- Irmandade Da Santa Casa de Misericordia de Sao Paulo
- Fundacao Jose Luiz Egydio Setubal
- SHATPPD - Ruse Ltd.
- Fifth MHAT - Sofia
- MHAT 'Lyulin' EAD
- Acibadem City Clinic Tokuda Hospital
- DCC II- Sofia EOOD
- Medical Center 'N. I. Pirogov', EOOD
- Medical Center Excelsior OOD
- Military Medical Academy - Sofia
- MHAT Dr Stefan Cherkezov
- MC 'Sv. Ivan Rilski', OOD
- The Bailey Clinic
- Aggarwal and associates Ltd
- SKDS Research Inc.
- Bluewater Clinical Research Group Inc.
- Dr. Anil K Gupta Medicine Professional Corporation
- Commonwealth Medical Clinic
- Recherche Clinique Sigma Inc.
- Hospital El Pino
- Centro de Investigacion del Maule
- Hospital de Niños y Cunas
- Chinese PLA General Hospital
- Fuzhou General Hospital of Nanjing Military Command
- The First Affiliated Hospital of NanChang University
- Wuxi People's Hospital
- Henan province people's hospital
- ADMED s.r.o.
- Sanare, s.r.o.
- Nemocnice Kyjov, p.o.
- Praktik Pb s.r.o
- SARKAMED s.r.o.
- Prakticky lekar
- Private GP Ilme Last
- Vee Family Doctor's Center OY
- OU Innomedica
- Merelahe Family Doctors Center
- Pirita Family Doctors Centre
- Family Doctors Pullerits & Gavronski
- Centre Hospitalier d'Agen
- Centre Hospitalier Intercommunal de Créteil
- Centre Hospitalier Départemental
- CHU de Grenoble - Hôpital Albert Michallon
- CHU Nantes - Hotel Dieu
- CHU de Nice, Hopital de l'Archet
- Hopital Cochin
- Hôpital Bichat - Claude Bernard
- MECS GmbH Cottbus
- Jung, Thomas
- Universitaetsklinik Erlangen
- Universitaetsklinikum Giessen und Marburg GmbH
- Universitaetsklinikum Koeln
- Gemeinschaftspraxis Dr. Klein/ Minnich
- Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
- DRC Gyogyszervizsgalo Kozpont Kft
- Clinexpert Kft.
- Obudai Egeszsegugyi Centrum Kft.
- Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
- Egeszsegkert Medicina Bt.
- Pestszentimrei Gyermekrendelő
- Bugat Pal Korhaz
- Futurenest Klinikai Kutato Kft.
- Mohacsi Korhaz
- Borbanya Praxis Eu. Kft.
- Medifarma-98 Kft.
- DRC Szentendre
- Tudogyogyintezet Torokbalint
- DRC Zamardi
- DRC Zirc
- Rajiv Gandhi Institute of Medical Sciences
- M S Ramaiah Memorial Hospital
- S. R. Kalla Memorial General Hospital
- Midland Healthcare & Research Center
- Kasturba Medical College Hospital
- Suretech Hospital and Research Centre Limited
- Siddhi Hospital
- BLK Super Specialty Hospital
- Sir Ganga Ram Hospital
- Sahyadri Speciality Hospital
- Lifepoint Multispecialty Hospital
- Shree Giriraj Multispeciality Hospital
- Unique Hospital
- BAPS Pramukhswami Hospital
- Barzilai Medical Center
- Bnai Zion Medical Center
- Galilee Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Ziv Medical Center
- ASST Grande Ospedale Metropolitano Niguarda
- AOU Policlinico di Modena
- Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
- Azienda Ospedaliera Universitaria Integrata Verona
- Korea University Ansan Hospital
- Chungbuk National University Hospital
- Yonsei University Wonju Severance Christian Hospital
- Hallym University Dongtan Sacred Heart Hospital
- Inha University Hospital
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Dong-A University Hospital
- Korea University Anam Hospital
- Konkuk University Medical Center
- Asan Medical Center
- Hallym University Kangnam Sacred Heart Hospital
- Korea University Guro Hospital
- The Catholic university of Korea, ST Vincent Hospital
- Liga Kozlovska family doctor practice
- OLVI Medical Centre
- Baiba Bake GP practice
- Ruta Eglite's Private Practice
- Inese Cebere GP practice
- S. Boreiko Doctor's Practice
- Children's Clinical University Hospital
- Clinic of GP A.Lasmanis 'ALMA'
- Health Centre 4
- Inese Petrova General Practitioner Practice
- Medical Practice BINI
- Auki Sveikas
- Silainiai Family Health Center, JSC
- Saules Seimos Medicinos Centras, JSC
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics
- Siauliai Republican Hospital, Public Institution
- Inlita, JSC, Lazdynai KTC clinical trial site
- Central Outpatient Clinic
- Inlita, JSC
- Vilnius University Hospital Santaros Klinikos, Public Institution
- Klinik Kesihatan Cheras Baru
- Klinik Kesihatan Kuang
- Hospital Miri
- Hospital Taiping
- Hospital Cardiologica Aguascalientes
- Hospital Infantil de Mexico Federico Gomez
- Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
- Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
- Hospital Civil de Guadalajara Fray Antonio Alcalde
- Hospital Civil de Guadalajara Dr. Juan I. Menchaca
- Centro Medico Jojutla
- Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
- Clinical Trials Mexico S.A. de C.V.
- Huisartsenpraktijk Mangal
- Huisartsenpraktijk Zijtregtop
- Huisartsenpraktijk Top
- Southern Clinical Trials Ltd
- Culloden Research Ltd
- Lakeland Family Medical Services Ltd
- Wellington Hospital
- Complejo Hospitalario San Pablo
- Clínica Sanna San Borja
- Clínica Internacional
- Hospital Maria Auxiliadora
- Clinica Peruano Americana S.A
- Malopolskie Centrum Alergologii
- Centrum Medyczne w Lancucie Sp.z o.o.
- ETG Lodz
- Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.
- Gabinet Lekarski Pediatryczno-Alergologiczny
- NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska
- Institute Of Epidimiology And Microbiology
- Limited Liability company 'MSMC' Euromed
- LLC Outpatient department of Private Security Guards and Detectives
- LLC Institute of Medical Examinations
- FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF
- LLC Kurator
- LLC 'ArsVite'
- Siberian State Medical University
- Clinical Hospital #3
- SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF
- Alersa, S.R.O.
- Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
- Plucna ambulancia Hrebenar, s.r.o.
- Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
- Cardiology Clinical Research
- Josha Research
- Moriana Clinical Research
- Dr Dindar & Partner
- Endocare Research
- Uhuru Clinical Trial Centre
- Dr EL Janari Private Practice
- Precise Clinical Solutions
- Global Clinical Research SA
- Abdullah, IA
- Sebastian, Peter
- Pillai, P
- Govind, U
- Jeevren Reddy, MD
- CRISMO Bertha Gxowa Research Centre
- Peermed Clinical Trial Centre
- DJW Research
- Aliwal Shoal Medical Centre
- Dr A Jacovides Clinical Trials Inc.
- Dr AA Mahomed Medical Centre
- Newtown Clinical Research
- Pillay, SR
- Smartmed Research Centre
- Emmed Research
- Botho ke Bontle Health Services
- Into Research
- Jongaie Research
- Queenswood Clinical Trial Centre
- Engelbrecht, I
- Johese Clinical Research
- Wits Clinical Research
- Limpopo Clinical Research Initiative
- Clinteam Vaal Clinical Trial Centre
- Welkom Clinical Trial Centre
- Hosp. Gral. Univ. de Elche
- Hosp. Univ. San Cecilio
- Hosp. Univ. Virgen de Las Nieves
- Hosp. Univ. de La Princesa
- Hosp. Clinico San Carlos
- Hosp. Univ. 12 de Octubre
- Hosp. Univ. La Paz
- Hosp. Univ. Hm Monteprincipe
- Hosp. Clinico Univ. de Santiago
- Hosp. Alvaro Cunqueiro
- Department for Heart Failure and Valvular Disease
- City Diabetes
- Norrlands Universitetssjukhus
- Akademiska Sjukhuset
- Taipei Medical University Shuang-Ho Hospital
- Kuang Tien General Hospital, Shalu
- Taipei Medical University
- National Taiwan University Hospital
- Taipei Medical University-Wan Fang Hospital
- The Hospital for Tropical Diseases
- Siriraj Hospital
- Srinagarind Hospital
- Bamrasnaradura Infectious Disease Institute
- Bumrungrad Hospital
- Hacettepe University Medical Faculty
- Adnan Menderes University
- Uludag University Medical Faculty
- Diyarbakir University Medical Faculty
- Kocaeli University Medical Faculty
- Hacettepe University Medical Faculty
- Karadeniz Teknik University Medical Faculty
- Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE
- Kyiv Oleksandrivska Clinical Hospital
- Odesa City Municipal Institution Polyclinic #20
- Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
- CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
- Swan Lane Medical Centre
- Bodey Medical Centre
- Barlow Medical Centre
- West Timperley Medical Centre
- Northenden Group Practice
- Bach Mai Hospital
- National Hospital for Tropical Diseases
- Nguyen Tri Phuong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Arm 1 (pimodivir + SOC treatment)
Treatment Arm 2 (placebo + SOC treatment)
Arm Description
Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).
Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Outcomes
Primary Outcome Measures
Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Secondary Outcome Measures
Number of Participants Hospitalized After Treatment Initiation
The number of participants hospitalized after treatment initiation were reported.
Viral Load Over Time
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Number of Participants With Emergence of Viral Resistance to Pimodivir
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Plasma Concentration of Pimodivir
Plasma concentration of Pimodivir was reported.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants With Clinically Significant Changes in Laboratory Tests
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
Full Information
NCT ID
NCT03381196
First Posted
December 18, 2017
Last Updated
April 30, 2021
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03381196
Brief Title
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Official Title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Based on interim Analysis outcome being futile for FLZ3001; decision was taken to stop (early terminate) both FLZ3001/3002. There was no safety concern.
Study Start Date
January 21, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
August 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
Detailed Description
This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (greater than [>] 65 but less than or equal to [<=] 85 years) non-hospitalized participants with influenza A infection who are at risk of developing complications. The study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). Study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (PK), PK/pharmacodynamics, biomarkers, safety and tolerability. The duration of participation in the study for each participant is 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
553 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm 1 (pimodivir + SOC treatment)
Arm Type
Experimental
Arm Description
Participants will receive pimodivir 600 milligram (mg), orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with Standard-of-Care (SOC) treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected adverse event (AE).
Arm Title
Treatment Arm 2 (placebo + SOC treatment)
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to pimodivir orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon). An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during the treatment period, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Intervention Type
Drug
Intervention Name(s)
Pimodivir 600 mg
Other Intervention Name(s)
JNJ-63623872
Intervention Description
Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6).
Intervention Type
Other
Intervention Name(s)
SOC Treatment
Intervention Description
Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
Primary Outcome Measure Information:
Title
Time to Resolution of 7 Primary Influenza-related Symptoms as Assessed by the Patient-Reported Outcome (PRO) Measure Flu-Intensity and Impact Questionnaire (Flu-iiQ)
Description
The Flu-iiQ is a PRO that measures influenza symptom intensity (none, mild, moderate, or severe) on a 4 point Likert response rating scale ranging from 0 to 3, where "0" represents the absence of symptom and "3" represents the severe symptom. The resolution of influenza-related symptoms is defined as the beginning of the 24-hour period that 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) are at most mild or at least back to previous level of symptom severity in case the participant reported the symptom as pre-existing.
Time Frame
Up to Day 28
Secondary Outcome Measure Information:
Title
Number of Participants Hospitalized After Treatment Initiation
Description
The number of participants hospitalized after treatment initiation were reported.
Time Frame
Up to Day 28
Title
Viral Load Over Time
Description
Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.
Time Frame
Baseline, Day 3, 6, 10, 14
Title
Number of Participants With Emergence of Viral Resistance to Pimodivir
Description
Emergence of viral resistance to pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).
Time Frame
Up to Day 28
Title
Plasma Concentration of Pimodivir
Description
Plasma concentration of Pimodivir was reported.
Time Frame
Day 3, 6, 7
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to Day 28
Title
Number of Participants With Clinically Significant Changes in Laboratory Tests
Description
Number of participants with clinically significant changes in laboratory tests were reported. Blood samples for hematology, serum chemistry, and urinalysis was collected at predefined time points for clinical laboratory testing.
Time Frame
Up to Day 28
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Description
Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.
Time Frame
Up to Day 28
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) were reported.
Time Frame
Up to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
Enrollment and initiation of study drug treatment less than or equal to (<=)72 hours after onset of influenza symptoms
Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease [presence of kidney damage for >3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests], or participants taking chronic systemic steroids)
Exclusion Criteria:
Received more than (>)1 dose of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir >1 day prior to screening
Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus [CD4+] count <200 cells per cubic millimeter [cells/mm^3], absolute neutrophil count <750/mm^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Cahaba Research Inc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Scottsboro Quick Care Clinic
City
Scottsboro
State/Province
Alabama
ZIP/Postal Code
35768
Country
United States
Facility Name
SC Clinical Research Inc.
City
California City
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Research Center of Fresno Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Allied Clinical Research
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Innovative Clinical Research, Inc.
City
Harbor City
State/Province
California
ZIP/Postal Code
90710
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Ark Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Downtown LA Research Center, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
California Allergy & Asthma Medical Group Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Adam D. Karns, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Lucita M. Cruz Md Inc
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Asclepes Research
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Center for Clinical Trials LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95684
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Diego Sports Medicine & Family Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92129
Country
United States
Facility Name
West Coast Clinical Research, LLC
City
San Ramon
State/Province
California
ZIP/Postal Code
94582
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5640
Country
United States
Facility Name
Lynn Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Complete Family Care
City
Northglenn
State/Province
Colorado
ZIP/Postal Code
80234
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Moonshine Research Center, Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Best Quality Research Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Floridian Clinical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
The community Research of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Encore Medical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
46112
Country
United States
Facility Name
Homestead Associates in Research, Inc
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Care Partners Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32218
Country
United States
Facility Name
Premier Medical Group
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Crystal Biomedical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Sima Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Universal Clinical Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
South Florida Research Center Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
A Plus Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Nuren Medical & Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Vista Health Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Combined Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Clinical NeuroScience Solutions, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Pines Care Research Center Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
South Broward Research, LLC
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Destin Pulmonary Critical Care, PLLS.
City
Santa Rosa Beach
State/Province
Florida
ZIP/Postal Code
32459
Country
United States
Facility Name
Vita Health and Medical center
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Asclepes Research
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
Axcess Medical Research, LLC
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Cozy Research, Llc
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33541
Country
United States
Facility Name
Snake River Research, PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saltzer Medical Group
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigators Research Group, LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Medisphere Medical Research Center, Llc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Hutchinson Clinic
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Medpharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
North Star Clinical Research, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
University Of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Wayne State Univ School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
97205
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Tri County Research, Inc.
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48310-3503
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Arcturus Healthcare, PLC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Craig A. Spiegel, MD
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Montana Medical Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Barrett Clinic P.C.
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Next Phase Research Alliance
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Saint Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
PMG Research
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Onsite Clinical Solutions
City
Clemmons
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
clinical research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Hickory Research Center.
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Burke Primary Care
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
PMG Research of Rocky Mount, LLC
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Clinical Trials of America
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Southeastern Research Center LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Buckeye Health and Research, LLC
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43027
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
29720
Country
United States
Facility Name
Detweiler Family Medicine and Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Preferred Primary Care Physicians Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Frontier Clinical Research
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Preferred Primary Care Physicians Research
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
AAPRI Clinical Research Institute
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Spectrum Medical Research
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
PMG Research of Charleston, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Fusion Clinical Research of Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Invocare Clinical Research Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
PMG Research of Bristol
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
PMG Research of Knoxville
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
HIRG, LLC dba Health Innovation Research Group
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
ACRC Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
Family Medicine Associates of Texas
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
WR-Global Medical Research, LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
University Of Texas Medical Branch At Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
San Gabriel Clinical Research, LLC
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
West Houston Clinical Research Service
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Northwest Med Care,P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Dairy Ashford Family Practice
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Facility Name
JM Research.PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77083
Country
United States
Facility Name
PCP for Life
City
Houston
State/Province
Texas
ZIP/Postal Code
77093-6731
Country
United States
Facility Name
SMS Clinical Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Village Health Partners
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Tekton Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
DM Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Renovatio Clinical
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
Val Hansen
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Ericksen Research and Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
J. Lewis research Inc./ Foothill Family Clinic South
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Granger Medical Clinic-Riverton
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
J. Lewis research Inc./ Foothill Family Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis research Inc./ Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research Inc/ FirstMed East
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research Inc./Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Millennium Clinical Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Hospital Interzonal General de Agudos Dr. Jose Penna
City
Bahia Blanca
ZIP/Postal Code
B8001DDU
Country
Argentina
Facility Name
CEMIC Saavedra
City
Ciudad de Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital Nuestra Señora de la Misericordia
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Sanatorio Allende
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Hospital Cordoba
City
Cordoba
ZIP/Postal Code
X5004CDT
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Hospital Rawson
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Hospital San Roque
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Sanatorio Juan XXIII
City
General Roca
ZIP/Postal Code
8332
Country
Argentina
Facility Name
Sanatorio del Oeste Ituzaingo
City
Ituzaingo
ZIP/Postal Code
1714
Country
Argentina
Facility Name
Hospital Italiano de La Plata
City
La Plata Lpl Lpl
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Instituto Medico Platense
City
La Plata
ZIP/Postal Code
B1900AVG
Country
Argentina
Facility Name
Sanatorio Britanico S.A.
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto Del Buen Aire
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Northside Health
City
Coffs Harbour
ZIP/Postal Code
2450
Country
Australia
Facility Name
Mater Hospital Brisbane
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Facility Name
AKH - Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
SMZ Süd - Kaiser Franz Josef Spital Wien
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Hopital Erasme
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
De Meulemeester, Marc
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Jaak Mortelmans
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Quartier du Furgy 4
City
Herbeumont
ZIP/Postal Code
6887
Country
Belgium
Facility Name
Research Link
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
BVBA Dr. Luc Capiau
City
Massemen
ZIP/Postal Code
9230
Country
Belgium
Facility Name
Testumed
City
Tessenderlo
ZIP/Postal Code
3980
Country
Belgium
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Infection Control Ltda
City
Brasil
ZIP/Postal Code
30110-063
Country
Brazil
Facility Name
Hrpc Ulbratech - Ulbra
City
Canoas
ZIP/Postal Code
92425
Country
Brazil
Facility Name
Centro de Estudos Clínicos do Interior Paulista - CECIP
City
Jaú
ZIP/Postal Code
17201-150
Country
Brazil
Facility Name
CMiP - Centro Mineiro de Pesquisa
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Pesquisare Saude
City
Santo André
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
CEMEC - Centro Multidisciplinar de Estudos Clínicos
City
São Bernardo do Campo
ZIP/Postal Code
09780-000
Country
Brazil
Facility Name
Irmandade Da Santa Casa de Misericordia de Sao Paulo
City
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Fundacao Jose Luiz Egydio Setubal
City
São Paulo
ZIP/Postal Code
01227-200
Country
Brazil
Facility Name
SHATPPD - Ruse Ltd.
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Fifth MHAT - Sofia
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT 'Lyulin' EAD
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC II- Sofia EOOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Medical Center 'N. I. Pirogov', EOOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Medical Center Excelsior OOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Military Medical Academy - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT Dr Stefan Cherkezov
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
MC 'Sv. Ivan Rilski', OOD
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
The Bailey Clinic
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Aggarwal and associates Ltd
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
SKDS Research Inc.
City
NewMarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Dr. Anil K Gupta Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Commonwealth Medical Clinic
City
Mount Pearl
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Recherche Clinique Sigma Inc.
City
Quebec
ZIP/Postal Code
G1G 4A2
Country
Canada
Facility Name
Hospital El Pino
City
San Bernardo
Country
Chile
Facility Name
Centro de Investigacion del Maule
City
Talca
ZIP/Postal Code
00000
Country
Chile
Facility Name
Hospital de Niños y Cunas
City
Viña
Country
Chile
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Military Command
City
Fuzhou
ZIP/Postal Code
350000
Country
China
Facility Name
The First Affiliated Hospital of NanChang University
City
NanChang
ZIP/Postal Code
330006
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
ZIP/Postal Code
214000
Country
China
Facility Name
Henan province people's hospital
City
Zhengzhou
Country
China
Facility Name
ADMED s.r.o.
City
Ceske Budejovice
ZIP/Postal Code
37006
Country
Czechia
Facility Name
Sanare, s.r.o.
City
Ceské Budejovice
ZIP/Postal Code
37006
Country
Czechia
Facility Name
Nemocnice Kyjov, p.o.
City
Kyjov
ZIP/Postal Code
697 01
Country
Czechia
Facility Name
Praktik Pb s.r.o
City
Pribram
ZIP/Postal Code
26101
Country
Czechia
Facility Name
SARKAMED s.r.o.
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Prakticky lekar
City
Sokolov
ZIP/Postal Code
356 01
Country
Czechia
Facility Name
Private GP Ilme Last
City
Paide
ZIP/Postal Code
72712
Country
Estonia
Facility Name
Vee Family Doctor's Center OY
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
OU Innomedica
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Merelahe Family Doctors Center
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Pirita Family Doctors Centre
City
Tallinn
ZIP/Postal Code
11911
Country
Estonia
Facility Name
Family Doctors Pullerits & Gavronski
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Centre Hospitalier d'Agen
City
Agen cedex 9
ZIP/Postal Code
47923
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Creteil cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Départemental
City
La Roche S/ Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
CHU de Grenoble - Hôpital Albert Michallon
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Nantes - Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice, Hopital de l'Archet
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Cochin
City
Paris 75
ZIP/Postal Code
75679 Cedex 14
Country
France
Facility Name
Hôpital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
MECS GmbH Cottbus
City
Cottbus
ZIP/Postal Code
03050
Country
Germany
Facility Name
Jung, Thomas
City
Deggingen
ZIP/Postal Code
73326
Country
Germany
Facility Name
Universitaetsklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitaetsklinikum Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Klein/ Minnich
City
Kuenzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
City
Leipzig
ZIP/Postal Code
04249
Country
Germany
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Clinexpert Kft.
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Egeszsegkert Medicina Bt.
City
Budapest
ZIP/Postal Code
1171
Country
Hungary
Facility Name
Pestszentimrei Gyermekrendelő
City
Budapest
ZIP/Postal Code
1188
Country
Hungary
Facility Name
Bugat Pal Korhaz
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Futurenest Klinikai Kutato Kft.
City
Miskolc
ZIP/Postal Code
3527
Country
Hungary
Facility Name
Mohacsi Korhaz
City
Mohacs
ZIP/Postal Code
7700
Country
Hungary
Facility Name
Borbanya Praxis Eu. Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Medifarma-98 Kft.
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
DRC Szentendre
City
Szentendre
ZIP/Postal Code
2000
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
DRC Zamardi
City
Zamardi
ZIP/Postal Code
8621
Country
Hungary
Facility Name
DRC Zirc
City
Zirc
ZIP/Postal Code
8420
Country
Hungary
Facility Name
Rajiv Gandhi Institute of Medical Sciences
City
Balaga
ZIP/Postal Code
532001
Country
India
Facility Name
M S Ramaiah Memorial Hospital
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
S. R. Kalla Memorial General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Midland Healthcare & Research Center
City
Lucknow
ZIP/Postal Code
226006
Country
India
Facility Name
Kasturba Medical College Hospital
City
Manipal
ZIP/Postal Code
576104
Country
India
Facility Name
Suretech Hospital and Research Centre Limited
City
Nagpur
ZIP/Postal Code
400012
Country
India
Facility Name
Siddhi Hospital
City
Nashik
ZIP/Postal Code
422007
Country
India
Facility Name
BLK Super Specialty Hospital
City
New Delhi
ZIP/Postal Code
110005
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Lifepoint Multispecialty Hospital
City
Pune
ZIP/Postal Code
411023
Country
India
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
ZIP/Postal Code
360005
Country
India
Facility Name
Unique Hospital
City
Surat
ZIP/Postal Code
395002
Country
India
Facility Name
BAPS Pramukhswami Hospital
City
Surat
ZIP/Postal Code
395009
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
AOU Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Korea University Ansan Hospital
City
Ansan-si
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Gangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong-si
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22322
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Pusan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
8308
Country
Korea, Republic of
Facility Name
The Catholic university of Korea, ST Vincent Hospital
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Liga Kozlovska family doctor practice
City
Balvi
ZIP/Postal Code
LV4501
Country
Latvia
Facility Name
OLVI Medical Centre
City
Daugavpils
ZIP/Postal Code
LV-5401
Country
Latvia
Facility Name
Baiba Bake GP practice
City
Jelgava
ZIP/Postal Code
LV3001
Country
Latvia
Facility Name
Ruta Eglite's Private Practice
City
Kuldiga
ZIP/Postal Code
LV-3301
Country
Latvia
Facility Name
Inese Cebere GP practice
City
Liepaja
ZIP/Postal Code
LV-3401
Country
Latvia
Facility Name
S. Boreiko Doctor's Practice
City
Ogre
ZIP/Postal Code
LV-5001
Country
Latvia
Facility Name
Children's Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Facility Name
Clinic of GP A.Lasmanis 'ALMA'
City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
Health Centre 4
City
Riga
ZIP/Postal Code
LV-1012
Country
Latvia
Facility Name
Inese Petrova General Practitioner Practice
City
Tukums
ZIP/Postal Code
LV-3101
Country
Latvia
Facility Name
Medical Practice BINI
City
Ventspils
ZIP/Postal Code
LV3601
Country
Latvia
Facility Name
Auki Sveikas
City
Kaunas
ZIP/Postal Code
44175
Country
Lithuania
Facility Name
Silainiai Family Health Center, JSC
City
Kaunas
ZIP/Postal Code
48259
Country
Lithuania
Facility Name
Saules Seimos Medicinos Centras, JSC
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Facility Name
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Siauliai Republican Hospital, Public Institution
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
Facility Name
Inlita, JSC, Lazdynai KTC clinical trial site
City
Vilnius
ZIP/Postal Code
4130
Country
Lithuania
Facility Name
Central Outpatient Clinic
City
Vilnius
ZIP/Postal Code
LT-01117
Country
Lithuania
Facility Name
Inlita, JSC
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Facility Name
Vilnius University Hospital Santaros Klinikos, Public Institution
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Klinik Kesihatan Cheras Baru
City
Cheras Baru
ZIP/Postal Code
56100
Country
Malaysia
Facility Name
Klinik Kesihatan Kuang
City
Kuang
ZIP/Postal Code
48050
Country
Malaysia
Facility Name
Hospital Miri
City
Miri
ZIP/Postal Code
98000
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital Infantil de Mexico Federico Gomez
City
Ciudad De Mexico
ZIP/Postal Code
6720
Country
Mexico
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
City
Culiacan
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
City
Guadalajara
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Centro Medico Jojutla
City
Jojutla De Juárez
ZIP/Postal Code
62900
Country
Mexico
Facility Name
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Clinical Trials Mexico S.A. de C.V.
City
Pahucha
ZIP/Postal Code
42070
Country
Mexico
Facility Name
Huisartsenpraktijk Mangal
City
Den Haag
ZIP/Postal Code
2565 KV
Country
Netherlands
Facility Name
Huisartsenpraktijk Zijtregtop
City
Rotterdam
ZIP/Postal Code
3037 AN
Country
Netherlands
Facility Name
Huisartsenpraktijk Top
City
Zwijndrecht
ZIP/Postal Code
3334 SB
Country
Netherlands
Facility Name
Southern Clinical Trials Ltd
City
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Culloden Research Ltd
City
Papamoa
ZIP/Postal Code
3118
Country
New Zealand
Facility Name
Lakeland Family Medical Services Ltd
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Complejo Hospitalario San Pablo
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Clínica Sanna San Borja
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Clínica Internacional
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Facility Name
Clinica Peruano Americana S.A
City
Trujillo
ZIP/Postal Code
13007
Country
Peru
Facility Name
Malopolskie Centrum Alergologii
City
Krakow
ZIP/Postal Code
31-624
Country
Poland
Facility Name
Centrum Medyczne w Lancucie Sp.z o.o.
City
Lancut
ZIP/Postal Code
37-100
Country
Poland
Facility Name
ETG Lodz
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.
City
Specjalistyczna W Brzegu Dolnym
ZIP/Postal Code
58-120
Country
Poland
Facility Name
Gabinet Lekarski Pediatryczno-Alergologiczny
City
Sucha Beskidzka
ZIP/Postal Code
34-200
Country
Poland
Facility Name
NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Institute Of Epidimiology And Microbiology
City
Kazan
ZIP/Postal Code
420015
Country
Russian Federation
Facility Name
Limited Liability company 'MSMC' Euromed
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
LLC Outpatient department of Private Security Guards and Detectives
City
Saint-Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
LLC Institute of Medical Examinations
City
Saint-Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
LLC Kurator
City
St. Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Facility Name
LLC 'ArsVite'
City
Stavropol
ZIP/Postal Code
355020
Country
Russian Federation
Facility Name
Siberian State Medical University
City
Tomsk
ZIP/Postal Code
634061
Country
Russian Federation
Facility Name
Clinical Hospital #3
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Facility Name
SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF
City
Yaroslavl
ZIP/Postal Code
150010
Country
Russian Federation
Facility Name
Alersa, S.R.O.
City
Kosice
ZIP/Postal Code
04022
Country
Slovakia
Facility Name
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
City
Michalovce
ZIP/Postal Code
07101
Country
Slovakia
Facility Name
Plucna ambulancia Hrebenar, s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Facility Name
Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
City
Svidnik
ZIP/Postal Code
08901
Country
Slovakia
Facility Name
Cardiology Clinical Research
City
Alberton
ZIP/Postal Code
1449
Country
South Africa
Facility Name
Josha Research
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Moriana Clinical Research
City
Brandfort
ZIP/Postal Code
9400
Country
South Africa
Facility Name
Dr Dindar & Partner
City
Breyten
ZIP/Postal Code
2330
Country
South Africa
Facility Name
Endocare Research
City
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Uhuru Clinical Trial Centre
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Dr EL Janari Private Practice
City
Cape Town
ZIP/Postal Code
7945
Country
South Africa
Facility Name
Precise Clinical Solutions
City
Chatsworth
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Global Clinical Research SA
City
Durban North
ZIP/Postal Code
4051
Country
South Africa
Facility Name
Abdullah, IA
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Sebastian, Peter
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pillai, P
City
Durban
ZIP/Postal Code
4068
Country
South Africa
Facility Name
Govind, U
City
Durban
ZIP/Postal Code
4096
Country
South Africa
Facility Name
Jeevren Reddy, MD
City
Durban
ZIP/Postal Code
4450
Country
South Africa
Facility Name
CRISMO Bertha Gxowa Research Centre
City
Johannesburg
ZIP/Postal Code
1401
Country
South Africa
Facility Name
Peermed Clinical Trial Centre
City
Kempton Park
ZIP/Postal Code
1619
Country
South Africa
Facility Name
DJW Research
City
Krugersdorp
ZIP/Postal Code
1739
Country
South Africa
Facility Name
Aliwal Shoal Medical Centre
City
KwaZulu-Natal
ZIP/Postal Code
4170
Country
South Africa
Facility Name
Dr A Jacovides Clinical Trials Inc.
City
Midrand
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Dr AA Mahomed Medical Centre
City
Moloto
ZIP/Postal Code
1022
Country
South Africa
Facility Name
Newtown Clinical Research
City
Newtown
ZIP/Postal Code
2113
Country
South Africa
Facility Name
Pillay, SR
City
Ottawa
ZIP/Postal Code
4339
Country
South Africa
Facility Name
Smartmed Research Centre
City
Port Elizabeth
ZIP/Postal Code
6020
Country
South Africa
Facility Name
Emmed Research
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Botho ke Bontle Health Services
City
Pretoria
ZIP/Postal Code
0101
Country
South Africa
Facility Name
Into Research
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Jongaie Research
City
Pretoria
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Queenswood Clinical Trial Centre
City
Pretoria
ZIP/Postal Code
0186
Country
South Africa
Facility Name
Engelbrecht, I
City
Pretoria
ZIP/Postal Code
157
Country
South Africa
Facility Name
Johese Clinical Research
City
Pretoria
ZIP/Postal Code
1692
Country
South Africa
Facility Name
Wits Clinical Research
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Limpopo Clinical Research Initiative
City
Thabazimbi
ZIP/Postal Code
380
Country
South Africa
Facility Name
Clinteam Vaal Clinical Trial Centre
City
Van Der Bijl
ZIP/Postal Code
1911
Country
South Africa
Facility Name
Welkom Clinical Trial Centre
City
Welkom
ZIP/Postal Code
9460
Country
South Africa
Facility Name
Hosp. Gral. Univ. de Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hosp. Univ. San Cecilio
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hosp. Univ. Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Hm Monteprincipe
City
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Hosp. Clinico Univ. de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hosp. Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Department for Heart Failure and Valvular Disease
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
City Diabetes
City
Stockholm
ZIP/Postal Code
11157
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 87
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Taipei Medical University Shuang-Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Kuang Tien General Hospital, Shalu
City
Taichung
Country
Taiwan
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Medical University-Wan Fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Facility Name
The Hospital for Tropical Diseases
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Srinagarind Hospital
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Bamrasnaradura Infectious Disease Institute
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Bumrungrad Hospital
City
Wattana
ZIP/Postal Code
10110
Country
Thailand
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Adnan Menderes University
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Uludag University Medical Faculty
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Diyarbakir University Medical Faculty
City
Diyarbakir
ZIP/Postal Code
21080
Country
Turkey
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Samanpazari, Altindag
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Karadeniz Teknik University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE
City
Kharkiv
ZIP/Postal Code
61106
Country
Ukraine
Facility Name
Kyiv Oleksandrivska Clinical Hospital
City
Kyiv
ZIP/Postal Code
1601
Country
Ukraine
Facility Name
Odesa City Municipal Institution Polyclinic #20
City
Odesa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
City
Poltava
ZIP/Postal Code
36000
Country
Ukraine
Facility Name
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
City
Vinnytsia
ZIP/Postal Code
21021
Country
Ukraine
Facility Name
Swan Lane Medical Centre
City
Bolton
ZIP/Postal Code
BL 6 6QT
Country
United Kingdom
Facility Name
Bodey Medical Centre
City
Manchester
ZIP/Postal Code
M14 6WP
Country
United Kingdom
Facility Name
Barlow Medical Centre
City
Manchester
ZIP/Postal Code
M20 2RN
Country
United Kingdom
Facility Name
West Timperley Medical Centre
City
Manchester
ZIP/Postal Code
WA14 5PF
Country
United Kingdom
Facility Name
Northenden Group Practice
City
Northenden
ZIP/Postal Code
M22 4DH
Country
United Kingdom
Facility Name
Bach Mai Hospital
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
National Hospital for Tropical Diseases
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Nguyen Tri Phuong Hospital
City
Ho Chi Minh
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
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