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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03381196
Other study ID # CR108400
Secondary ID 2017-002217-5963
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 21, 2018
Est. completion date August 24, 2020

Study information

Verified date April 2021
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 553
Est. completion date August 24, 2020
Est. primary completion date May 28, 2020
Accepts healthy volunteers No
Gender All
Age group 13 Years to 85 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pimodivir 600 mg
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).
Placebo
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).
Other:
SOC Treatment
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).

Locations

Country Name City State
Argentina Hospital Interzonal General de Agudos Dr. Jose Penna Bahia Blanca
Argentina CEMIC Saavedra Ciudad de Buenos Aires
Argentina Hospital Cordoba Cordoba
Argentina Hospital Nuestra Señora de la Misericordia Cordoba
Argentina Hospital Privado Centro Medico de Cordoba Cordoba
Argentina Sanatorio Allende Cordoba
Argentina Hospital Rawson Córdoba
Argentina Hospital San Roque Córdoba
Argentina Sanatorio Juan XXIII General Roca
Argentina Sanatorio del Oeste Ituzaingo Ituzaingo
Argentina Instituto Medico Platense La Plata
Argentina Hospital Italiano de La Plata La Plata Lpl Lpl
Argentina Sanatorio Britanico S.A. Rosario
Argentina Instituto Del Buen Aire Santa Fe
Australia Northside Health Coffs Harbour
Australia Mater Hospital Brisbane South Brisbane
Austria AKH - Medizinische Universität Wien Wien
Austria SMZ Süd - Kaiser Franz Josef Spital Wien Wien
Belgium Hopital Erasme Brussel
Belgium CHU Saint-Pierre Bruxelles
Belgium Institut Jules Bordet Bruxelles
Belgium De Meulemeester, Marc Gozée
Belgium Jaak Mortelmans Ham
Belgium Quartier du Furgy 4 Herbeumont
Belgium Research Link Linkebeek
Belgium BVBA Dr. Luc Capiau Massemen
Belgium Testumed Tessenderlo
Brazil Santa Casa de Misericordia de Belo Horizonte Belo Horizonte
Brazil Infection Control Ltda Brasil
Brazil Hrpc Ulbratech - Ulbra Canoas
Brazil Centro de Estudos Clínicos do Interior Paulista - CECIP Jaú
Brazil CMiP - Centro Mineiro de Pesquisa Juiz de Fora
Brazil Hospital Sao Vicente de Paulo Passo Fundo
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre
Brazil Hospital São Lucas da PUCRS Porto Alegre
Brazil CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. Rio de Janeiro
Brazil Pesquisare Saude Santo André
Brazil CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo
Brazil Fundacao Jose Luiz Egydio Setubal São Paulo
Brazil Irmandade Da Santa Casa de Misericordia de Sao Paulo São Paulo
Bulgaria SHATPPD - Ruse Ltd. Ruse
Bulgaria Acibadem City Clinic Tokuda Hospital Sofia
Bulgaria DCC II- Sofia EOOD Sofia
Bulgaria Fifth MHAT - Sofia Sofia
Bulgaria Medical Center 'N. I. Pirogov', EOOD Sofia
Bulgaria Medical Center Excelsior OOD Sofia
Bulgaria MHAT 'Lyulin' EAD Sofia
Bulgaria Military Medical Academy - Sofia Sofia
Bulgaria MHAT Dr Stefan Cherkezov Veliko Tarnovo
Bulgaria MC 'Sv. Ivan Rilski', OOD Vidin
Canada Aggarwal and associates Ltd Brampton Ontario
Canada Commonwealth Medical Clinic Mount Pearl
Canada SKDS Research Inc. NewMarket Ontario
Canada Recherche Clinique Sigma Inc. Quebec
Canada The Bailey Clinic Red Deer Alberta
Canada Bluewater Clinical Research Group Inc. Sarnia Ontario
Canada Dr. Anil K Gupta Medicine Professional Corporation Toronto Ontario
Chile Hospital El Pino San Bernardo
Chile Centro de Investigacion del Maule Talca
Chile Hospital de Niños y Cunas Viña
China Chinese PLA General Hospital Beijing
China Fuzhou General Hospital of Nanjing Military Command Fuzhou
China The First Affiliated Hospital of NanChang University NanChang
China Wuxi People's Hospital Wuxi
China Henan province people's hospital Zhengzhou
Czechia ADMED s.r.o. Ceske Budejovice
Czechia Sanare, s.r.o. Ceské Budejovice
Czechia Nemocnice Kyjov, p.o. Kyjov
Czechia Praktik Pb s.r.o Pribram
Czechia SARKAMED s.r.o. Slany
Czechia Prakticky lekar Sokolov
Estonia Private GP Ilme Last Paide
Estonia Vee Family Doctor's Center OY Paide
Estonia Merelahe Family Doctors Center Tallinn
Estonia OU Innomedica Tallinn
Estonia Pirita Family Doctors Centre Tallinn
Estonia Family Doctors Pullerits & Gavronski Tartu
France Centre Hospitalier d'Agen Agen cedex 9
France Centre Hospitalier Intercommunal de Créteil Creteil cedex
France Centre Hospitalier Départemental La Roche S/ Yon Cedex 9
France CHU de Grenoble - Hôpital Albert Michallon La Tronche
France CHU Nantes - Hotel Dieu Nantes Cedex 1
France CHU de Nice, Hopital de l'Archet Nice Cedex 3
France Hôpital Bichat - Claude Bernard Paris
France Hopital Cochin Paris 75
Germany MECS GmbH Cottbus Cottbus
Germany Jung, Thomas Deggingen
Germany Universitaetsklinik Erlangen Erlangen
Germany Universitaetsklinikum Giessen und Marburg GmbH Giessen
Germany Universitaetsklinikum Koeln Koeln
Germany Gemeinschaftspraxis Dr. Klein/ Minnich Kuenzing
Germany Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut Leipzig
Hungary DRC Gyogyszervizsgalo Kozpont Kft Balatonfured
Hungary Clinexpert Kft. Budapest
Hungary Egeszsegkert Medicina Bt. Budapest
Hungary Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelo Budai Családközpontú Budapest
Hungary Obudai Egeszsegugyi Centrum Kft. Budapest
Hungary Pestszentimrei Gyermekrendelo Budapest
Hungary Bugat Pal Korhaz Gyongyos
Hungary Futurenest Klinikai Kutato Kft. Miskolc
Hungary Mohacsi Korhaz Mohacs
Hungary Borbanya Praxis Eu. Kft. Nyiregyhaza
Hungary Medifarma-98 Kft. Nyiregyhaza
Hungary DRC Szentendre Szentendre
Hungary Tudogyogyintezet Torokbalint Torokbalint
Hungary DRC Zamardi Zamardi
Hungary DRC Zirc Zirc
India Rajiv Gandhi Institute of Medical Sciences Balaga
India M S Ramaiah Memorial Hospital Bangalore
India S. R. Kalla Memorial General Hospital Jaipur
India Midland Healthcare & Research Center Lucknow
India Kasturba Medical College Hospital Manipal
India Suretech Hospital and Research Centre Limited Nagpur
India Siddhi Hospital Nashik
India BLK Super Specialty Hospital New Delhi
India Sir Ganga Ram Hospital New Delhi
India Lifepoint Multispecialty Hospital Pune
India Sahyadri Speciality Hospital Pune
India Shree Giriraj Multispeciality Hospital Rajkot
India BAPS Pramukhswami Hospital Surat
India Unique Hospital Surat
Israel Barzilai Medical Center Ashkelon
Israel Bnai Zion Medical Center Haifa
Israel Galilee Medical Center Nahariya
Israel Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rechovot
Israel Ziv Medical Center Safed
Italy ASST Grande Ospedale Metropolitano Niguarda Milano
Italy AOU Policlinico di Modena Modena
Italy Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo Monza
Italy Azienda Ospedaliera Universitaria Integrata Verona Verona
Korea, Republic of Korea University Ansan Hospital Ansan-si
Korea, Republic of Chungbuk National University Hospital Cheongju-si
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Gangwon-do
Korea, Republic of Hallym University Dongtan Sacred Heart Hospital Hwaseong-si
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of The Catholic University of Korea, Incheon St. Mary's Hospital Incheon
Korea, Republic of Dong-A University Hospital Pusan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of The Catholic university of Korea, ST Vincent Hospital Suwon-si
Latvia Liga Kozlovska family doctor practice Balvi
Latvia OLVI Medical Centre Daugavpils
Latvia Baiba Bake GP practice Jelgava
Latvia Ruta Eglite's Private Practice Kuldiga
Latvia Inese Cebere GP practice Liepaja
Latvia S. Boreiko Doctor's Practice Ogre
Latvia Children's Clinical University Hospital Riga
Latvia Clinic of GP A.Lasmanis 'ALMA' Riga
Latvia Health Centre 4 Riga
Latvia Inese Petrova General Practitioner Practice Tukums
Latvia Medical Practice BINI Ventspils
Lithuania Auki Sveikas Kaunas
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Kaunas
Lithuania Saules Seimos Medicinos Centras, JSC Kaunas
Lithuania Silainiai Family Health Center, JSC Kaunas
Lithuania Siauliai Republican Hospital, Public Institution Siauliai
Lithuania Central Outpatient Clinic Vilnius
Lithuania Inlita, JSC Vilnius
Lithuania Inlita, JSC, Lazdynai KTC clinical trial site Vilnius
Lithuania Vilnius University Hospital Santaros Klinikos, Public Institution Vilnius
Malaysia Klinik Kesihatan Cheras Baru Cheras Baru
Malaysia Klinik Kesihatan Kuang Kuang
Malaysia Hospital Miri Miri
Malaysia Hospital Taiping Taiping
Mexico Hospital Cardiologica Aguascalientes Aguascalientes
Mexico Hospital Infantil de Mexico Federico Gomez Ciudad De Mexico
Mexico Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. Culiacan
Mexico Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA Guadalajara
Mexico Hospital Civil de Guadalajara Dr. Juan I. Menchaca Guadalajara
Mexico Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara
Mexico Centro Medico Jojutla Jojutla De Juárez
Mexico Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez' Monterrey
Mexico Clinical Trials Mexico S.A. de C.V. Pahucha
Netherlands Huisartsenpraktijk Mangal Den Haag
Netherlands Huisartsenpraktijk Zijtregtop Rotterdam
Netherlands Huisartsenpraktijk Top Zwijndrecht
New Zealand Southern Clinical Trials Ltd Auckland
New Zealand Culloden Research Ltd Papamoa
New Zealand Lakeland Family Medical Services Ltd Rotorua
New Zealand Wellington Hospital Wellington
Peru Clínica Internacional Lima
Peru Clínica Sanna San Borja Lima
Peru Complejo Hospitalario San Pablo Lima
Peru Hospital Maria Auxiliadora Lima
Peru Clinica Peruano Americana S.A Trujillo
Poland Malopolskie Centrum Alergologii Krakow
Poland Centrum Medyczne w Lancucie Sp.z o.o. Lancut
Poland ETG Lodz Lodz
Poland Powiatowe Centrum Medyczne w Wolowie Sp. z o.o. Specjalistyczna W Brzegu Dolnym
Poland Gabinet Lekarski Pediatryczno-Alergologiczny Sucha Beskidzka
Poland NZOZ Centrum Badan Klinicznych,Piotr Napora,Lekarze Spólka Partnerska Wroclaw
Russian Federation Institute Of Epidimiology And Microbiology Kazan
Russian Federation Limited Liability company 'MSMC' Euromed Omsk
Russian Federation FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF Saint-Petersburg
Russian Federation LLC Institute of Medical Examinations Saint-Petersburg
Russian Federation LLC Outpatient department of Private Security Guards and Detectives Saint-Petersburg
Russian Federation LLC Kurator St. Petersburg
Russian Federation LLC 'ArsVite' Stavropol
Russian Federation Siberian State Medical University Tomsk
Russian Federation Clinical Hospital #3 Yaroslavl
Russian Federation SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF Yaroslavl
Slovakia Alersa, S.R.O. Kosice
Slovakia Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. Michalovce
Slovakia Plucna ambulancia Hrebenar, s.r.o. Spisska Nova Ves
Slovakia Nemocnica arm. generala L. Svobodu Svidnik, a.s., Svidnik
South Africa Cardiology Clinical Research Alberton
South Africa Josha Research Bloemfontein
South Africa Moriana Clinical Research Brandfort
South Africa Dr Dindar & Partner Breyten
South Africa Dr EL Janari Private Practice Cape Town
South Africa Endocare Research Cape Town
South Africa Uhuru Clinical Trial Centre Cape Town
South Africa Precise Clinical Solutions Chatsworth
South Africa Abdullah, IA Durban
South Africa Govind, U Durban
South Africa Jeevren Reddy, MD Durban
South Africa Pillai, P Durban
South Africa Sebastian, Peter Durban
South Africa Global Clinical Research SA Durban North
South Africa CRISMO Bertha Gxowa Research Centre Johannesburg
South Africa Peermed Clinical Trial Centre Kempton Park
South Africa DJW Research Krugersdorp
South Africa Aliwal Shoal Medical Centre KwaZulu-Natal
South Africa Dr A Jacovides Clinical Trials Inc. Midrand
South Africa Dr AA Mahomed Medical Centre Moloto
South Africa Newtown Clinical Research Newtown
South Africa Pillay, SR Ottawa
South Africa Smartmed Research Centre Port Elizabeth
South Africa Botho ke Bontle Health Services Pretoria
South Africa Emmed Research Pretoria
South Africa Engelbrecht, I Pretoria
South Africa Into Research Pretoria
South Africa Johese Clinical Research Pretoria
South Africa Jongaie Research Pretoria
South Africa Queenswood Clinical Trial Centre Pretoria
South Africa Wits Clinical Research Soweto
South Africa Limpopo Clinical Research Initiative Thabazimbi
South Africa Clinteam Vaal Clinical Trial Centre Van Der Bijl
South Africa Welkom Clinical Trial Centre Welkom
Spain Hosp. Gral. Univ. de Elche Elche
Spain Hosp. Univ. San Cecilio Granada
Spain Hosp. Univ. Virgen de Las Nieves Granada
Spain Hosp. Clinico San Carlos Madrid
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. de La Princesa Madrid
Spain Hosp. Univ. Hm Monteprincipe Madrid
Spain Hosp. Univ. La Paz Madrid
Spain Hosp. Clinico Univ. de Santiago Santiago de Compostela
Spain Hosp. Alvaro Cunqueiro Vigo
Sweden Department for Heart Failure and Valvular Disease Malmö
Sweden City Diabetes Stockholm
Sweden Norrlands Universitetssjukhus Umeå
Sweden Akademiska Sjukhuset Uppsala
Taiwan Taipei Medical University Shuang-Ho Hospital New Taipei City
Taiwan Kuang Tien General Hospital, Shalu Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Medical University-Wan Fang Hospital Taipei
Taiwan Taipei Medical University Taipei City
Thailand Siriraj Hospital Bangkok
Thailand The Hospital for Tropical Diseases Bangkok
Thailand Srinagarind Hospital Muang
Thailand Bamrasnaradura Infectious Disease Institute Nonthaburi
Thailand Bumrungrad Hospital Wattana
Turkey Hacettepe University Medical Faculty Ankara
Turkey Adnan Menderes University Aydin
Turkey Uludag University Medical Faculty Bursa
Turkey Diyarbakir University Medical Faculty Diyarbakir
Turkey Kocaeli University Medical Faculty Kocaeli
Turkey Hacettepe University Medical Faculty Samanpazari, Altindag
Turkey Karadeniz Teknik University Medical Faculty Trabzon
Ukraine Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE Kharkiv
Ukraine Kyiv Oleksandrivska Clinical Hospital Kyiv
Ukraine Odesa City Municipal Institution Polyclinic #20 Odesa
Ukraine Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy Poltava
Ukraine CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM Vinnytsia
United Kingdom Swan Lane Medical Centre Bolton
United Kingdom Barlow Medical Centre Manchester
United Kingdom Bodey Medical Centre Manchester
United Kingdom West Timperley Medical Centre Manchester
United Kingdom Northenden Group Practice Northenden
United States HIRG, LLC dba Health Innovation Research Group Arlington Texas
United States Millennium Clinical Trials, LLC Arlington Virginia
United States ACRC Trials Austin Texas
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States University Of Maryland Medical Center Baltimore Maryland
United States Alabama Clinical Therapeutics, LLC Birmingham Alabama
United States Cahaba Research Inc Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Val Hansen Bountiful Utah
United States Craig A. Spiegel, MD Bridgeton Missouri
United States PMG Research of Bristol Bristol Tennessee
United States Investigators Research Group, LLC Brownsburg Indiana
United States Mercury Street Medical Group, PLLC Butte Montana
United States SC Clinical Research Inc. California City California
United States Family Medicine Associates of Texas Carrollton Texas
United States PMG Research Cary North Carolina
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Onsite Clinical Solutions Clemmons North Carolina
United States Ericksen Research and Development Clinton Utah
United States Lynn Institute Colorado Springs Colorado
United States University of Texas Southwestern Medical Center Dallas Texas
United States Dayton Clinical Research Dayton Ohio
United States WR-Global Medical Research, LLC DeSoto Texas
United States Wayne State Univ School of Medicine Detroit Michigan
United States Wayne State University Detroit Michigan
United States Moonshine Research Center, Inc Doral Florida
United States J. Lewis research Inc./ Foothill Family Clinic South Draper Utah
United States Centennial Medical Group Elkridge Maryland
United States Medisphere Medical Research Center, Llc Evansville Indiana
United States Carolina Institute for Clinical Research Fayetteville North Carolina
United States Research Center of Fresno Inc Fresno California
United States Spectrum Medical Research Gaffney South Carolina
United States University Of Texas Medical Branch At Galveston Galveston Texas
United States clinical research of Gastonia Gastonia North Carolina
United States San Gabriel Clinical Research, LLC Georgetown Texas
United States Allied Clinical Research Gold River California
United States DeGarmo Institute of Medical Research Greer South Carolina
United States Innovative Clinical Research, Inc. Harbor City California
United States Best Quality Research Inc Hialeah Florida
United States Floridian Clinical Research, LLC Hialeah Florida
United States The community Research of South Florida Hialeah Florida
United States Hickory Research Center. Hickory North Carolina
United States Buckeye Health and Research, LLC Hilliard Ohio
United States Encore Medical Research, LLC Hollywood Florida
United States Homestead Associates in Research, Inc Homestead Florida
United States BI Research Center Houston Texas
United States Dairy Ashford Family Practice Houston Texas
United States JM Research.PLLC Houston Texas
United States Northwest Med Care,P.A. Houston Texas
United States PCP for Life Houston Texas
United States Southwest Clinical Trials Houston Texas
United States West Houston Clinical Research Service Houston Texas
United States Hutchinson Clinic Hutchinson Kansas
United States Snake River Research, PLLC Idaho Falls Idaho
United States Care Partners Clinical Research Jacksonville Florida
United States PMG Research of Knoxville Jefferson City Tennessee
United States PMG Research of Knoxville Knoxville Tennessee
United States Barrett Clinic P.C. La Vista Nebraska
United States Premier Medical Group Lady Lake Florida
United States Lancaster General Hospital Lancaster Pennsylvania
United States Om Research LLC Lancaster California
United States Detweiler Family Medicine and Associates Lansdale Pennsylvania
United States Next Phase Research Alliance Las Vegas Nevada
United States The Research Group of Lexington, LLC Lexington Kentucky
United States Ark Clinical Research Long Beach California
United States Miller Children's Hospital Long Beach California
United States Adam D. Karns, MD Los Angeles California
United States California Allergy & Asthma Medical Group Inc. Los Angeles California
United States Downtown LA Research Center, Inc Los Angeles California
United States SMS Clinical Research LLC Mesquite Texas
United States Clinical Trials Management, LLC Metairie Louisiana
United States Medpharmics, LLC Metairie Louisiana
United States A Plus Research Miami Florida
United States Coral Research Clinic Corp Miami Florida
United States New Horizon Research Center Miami Florida
United States Nuren Medical & Research Center Miami Florida
United States Sima Research Clinic Miami Florida
United States South Florida Research Center Inc. Miami Florida
United States Universal Clinical Research Associates Miami Florida
United States Vista Health Research, LLC Miami Florida
United States Crystal Biomedical Research Miami Lakes Florida
United States Montana Medical Research Missoula Montana
United States Monroe Biomedical Research Monroe North Carolina
United States Burke Primary Care Morganton North Carolina
United States PMG Research of Charleston, LLC Mount Pleasant South Carolina
United States Saltzer Medical Group Nampa Idaho
United States Saint Michael's Medical Center Newark New Jersey
United States Complete Family Care Northglenn Colorado
United States Lucita M. Cruz Md Inc Norwalk California
United States Advanced Research Institute Ogden Utah
United States Nebraska Medical Center Omaha Nebraska
United States Clinical NeuroScience Solutions, Inc Orlando Florida
United States Combined Research Orlando Orlando Florida
United States Omega Research Consultants Orlando Florida
United States Asclepes Research Panorama City California
United States Center for Clinical Trials LLC Paramount California
United States Pines Care Research Center Inc Pembroke Pines Florida
United States South Broward Research, LLC Pembroke Pines Florida
United States Albert Einstein Healthcare Network Philadelphia Pennsylvania
United States Preferred Primary Care Physicians Research Pittsburgh Pennsylvania
United States Village Health Partners Plano Texas
United States Health Concepts Rapid City South Dakota
United States Granger Medical Clinic-Riverton Riverton Utah
United States PMG Research of Rocky Mount, LLC Rocky Mount North Carolina
United States William Beaumont Hospital Royal Oak Michigan
United States Benchmark Research Sacramento California
United States J. Lewis research Inc./ Foothill Family Care Salt Lake City Utah
United States J. Lewis research Inc./ Foothill Family Clinic South Salt Lake City Utah
United States J. Lewis Research Inc/ FirstMed East Salt Lake City Utah
United States DM Clinical Research San Antonio Texas
United States Tekton Research Inc. San Antonio Texas
United States Medical Associates Research Group, Inc. San Diego California
United States San Diego Sports Medicine & Family Health Center San Diego California
United States West Coast Clinical Research, LLC San Ramon California
United States Destin Pulmonary Critical Care, PLLS. Santa Rosa Beach Florida
United States Scottsboro Quick Care Clinic Scottsboro Alabama
United States North Star Clinical Research, LLC Shreveport Louisiana
United States Frontier Clinical Research Smithfield Pennsylvania
United States J. Lewis Research Inc./Jordan River Family Medicine South Jordan Utah
United States Fusion Clinical Research of Spartanburg Spartanburg South Carolina
United States Stanford University Stanford California
United States Tri County Research, Inc. Sterling Heights Michigan
United States Vita Health and Medical center Tamarac Florida
United States Renovatio Clinical The Woodlands Texas
United States Arcturus Healthcare, PLC Troy Michigan
United States William Beaumont Hospital Troy Michigan
United States Preferred Primary Care Physicians Research Uniontown Pennsylvania
United States AAPRI Clinical Research Institute Warwick Rhode Island
United States Emerson Clinical Research Institute Washington District of Columbia
United States Chase Medical Research, LLC Waterbury Connecticut
United States ClinPoint Trials Waxahachie Texas
United States Asclepes Research Weeki Wachee Florida
United States Axcess Medical Research, LLC Wellington Florida
United States Invocare Clinical Research Center West Columbia South Carolina
United States Paradigm Clinical Research Centers, Inc. Wheat Ridge Colorado
United States PMG Research of Wilmington, LLC Wilmington North Carolina
United States Clinical Trials of America Winston-Salem North Carolina
United States Southeastern Research Center LLC Winston-Salem North Carolina
United States Cozy Research, Llc Zephyrhills Florida
Vietnam Bach Mai Hospital Hanoi
Vietnam National Hospital for Tropical Diseases Hanoi
Vietnam Nguyen Tri Phuong Hospital Ho Chi Minh

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czechia,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Peru,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to Day 28
Secondary Number of Participants Hospitalized After Treatment Initiation The number of participants hospitalized after treatment initiation were reported. Up to Day 28
Secondary 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. Baseline, Day 3, 6, 10, 14
Secondary 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). Up to Day 28
Secondary Plasma Concentration of Pimodivir Plasma concentration of Pimodivir was reported. Day 3, 6, 7
Secondary 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. Up to Day 28
Secondary 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. Up to Day 28
Secondary Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported. Up to Day 28
Secondary 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. Up to Day 28
See also
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