AzTrials
AzTrials

Influenza APhase 3NCT03381196

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

A Phase 3 study testing Pimodivir 600 mg and SOC Treatment in people with Influenza A, run by Janssen Research & Development, LLC at 427 sites in 38 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 13 to 85 years
Conditions the study is for
Influenza A
What is being tested?
Pimodivir 600 mg and SOC Treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
553 participants
Where
427 sitesin 38 countries
Study dates
21 Jan 2018to 24 Aug 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

427 sites in 38 countries.

427 sites in 38 countries

United States140 sites

  • HIRG, LLC dba Health Innovation Research Group

    Arlington, Texas, 76014

  • Millennium Clinical Trials LLC

    Arlington, Virginia, 22203

  • ACRC Trials

    Austin, Texas, 78735

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Cahaba Research Inc

    Birmingham, Alabama, 35242

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Val Hansen

    Bountiful, Utah, 84010

  • Craig A. Spiegel, MD

    Bridgeton, Missouri, 63044

  • PMG Research of Bristol

    Bristol, Tennessee, 37620

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • SC Clinical Research Inc.

    California City, California, 92844

  • Family Medicine Associates of Texas

    Carrollton, Texas, 75010

  • Accellacare Research of Cary

    Cary, North Carolina, 27518

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Onsite Clinical Solutions

    Clemmons, North Carolina, 27012

  • Ericksen Research and Development

    Clinton, Utah, 84015

  • Lynn Institute

    Colorado Springs, Colorado, 80920

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Dayton Clinical Research

    Dayton, Ohio, 45406

  • WR-Global Medical Research, LLC

    DeSoto, Texas, 75115

  • Wayne State Univ School of Medicine

    Detroit, Michigan, 48201

  • Wayne State University

    Detroit, Michigan, 97205

  • Moonshine Research Center, Inc

    Doral, Florida, 33166

  • J. Lewis research Inc./ Foothill Family Clinic South

    Draper, Utah, 84020

  • Centennial Medical Group

    Elkridge, Maryland, 21075

  • Medisphere Medical Research Center, Llc

    Evansville, Indiana, 47714

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28304

  • Research Center of Fresno Inc

    Fresno, California, 93702

  • Spectrum Medical Research

    Gaffney, South Carolina, 29341

  • University Of Texas Medical Branch At Galveston

    Galveston, Texas, 77555

  • clinical research of Gastonia

    Gastonia, North Carolina, 28054

  • San Gabriel Clinical Research, LLC

    Georgetown, Texas, 78626

  • Allied Clinical Research

    Gold River, California, 95670

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

  • Innovative Clinical Research Inc

    Harbor City, California, 90710

  • Best Quality Research Inc

    Hialeah, Florida, 33016

  • Floridian Clinical Research LLC

    Hialeah, Florida, 33016

  • The community Research of South Florida

    Hialeah, Florida, 33016

  • Hickory Research Center.

    Hickory, North Carolina, 28601

  • Buckeye Health and Research, LLC

    Hilliard, Ohio, 43027

  • Encore Medical Research, LLC

    Hollywood, Florida, 46112

  • Homestead Associates in Research Inc

    Homestead, Florida, 33032

  • BI Research Center

    Houston, Texas, 77043

  • West Houston Clinical Research Service

    Houston, Texas, 77055

  • Northwest Med Care,P.A.

    Houston, Texas, 77070

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Dairy Ashford Family Practice

    Houston, Texas, 77077

  • JM Research.PLLC

    Houston, Texas, 77083

  • PCP for Life

    Houston, Texas, 77093-6731

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • Care Partners Clinical Research

    Jacksonville, Florida, 32218

  • PMG Research of Knoxville

    Jefferson City, Tennessee, 37760

  • PMG Research of Knoxville

    Knoxville, Tennessee, 37912

  • Barrett Clinic P.C.

    La Vista, Nebraska, 68128

  • Premier Medical Group

    Lady Lake, Florida, 32159

  • Om Research LLC

    Lancaster, California, 93534

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 29720

  • Detweiler Family Medicine and Associates

    Lansdale, Pennsylvania, 19446

  • Next Phase Research Alliance

    Las Vegas, Nevada, 89119

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Ark Clinical Research

    Long Beach, California, 90806

  • Miller Children's Hospital

    Long Beach, California, 90806

  • Downtown LA Research Center, Inc

    Los Angeles, California, 90017

  • California Allergy & Asthma Medical Group Inc.

    Los Angeles, California, 90025

  • Adam D. Karns, MD

    Los Angeles, California, 90036

  • SMS Clinical Research LLC

    Mesquite, Texas, 75149

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Medpharmics, LLC

    Metairie, Louisiana, 70006

  • Sima Research Clinic

    Miami, Florida, 33125

  • Universal Clinical Research Associates

    Miami, Florida, 33134

  • South Florida Research Center Inc.

    Miami, Florida, 33135

  • A Plus Research

    Miami, Florida, 33144

  • Nuren Medical & Research Center

    Miami, Florida, 33144

  • Coral Research Clinic Corp

    Miami, Florida, 33175

  • New Horizon Research Center

    Miami, Florida, 33175

  • Vista Health Research, LLC

    Miami, Florida, 33176

  • Crystal Biomedical Research

    Miami Lakes, Florida, 33014

  • Montana Medical Research

    Missoula, Montana, 59808

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Burke Primary Care

    Morganton, North Carolina, 28655

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Saltzer Medical Group

    Nampa, Idaho, 83686

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • Complete Family Care

    Northglenn, Colorado, 80234

  • Lucita M. Cruz Md Inc

    Norwalk, California, 90650

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Combined Research Orlando

    Orlando, Florida, 32803

  • Clinical NeuroScience Solutions Inc

    Orlando, Florida, 32806

  • Omega Research Consultants

    Orlando, Florida, 32810

  • Asclepes Research

    Panorama City, California, 91402

  • Center for Clinical Trials LLC

    Paramount, California, 90723

  • Pines Care Research Center Inc

    Pembroke Pines, Florida, 33026

  • South Broward Research, LLC

    Pembroke Pines, Florida, 33027

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • Preferred Primary Care Physicians Research

    Pittsburgh, Pennsylvania, 15236

  • Village Health Partners

    Plano, Texas, 75024

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Granger Medical Clinic-Riverton

    Riverton, Utah, 84065

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Benchmark Research

    Sacramento, California, 95684

  • J. Lewis research Inc./ Foothill Family Care

    Salt Lake City, Utah, 84109

  • J. Lewis research Inc./ Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • J. Lewis Research Inc/ FirstMed East

    Salt Lake City, Utah, 84121

  • Tekton Research Inc.

    San Antonio, Texas, 78240

  • DM Clinical Research

    San Antonio, Texas, 78249

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • San Diego Sports Medicine & Family Health Center

    San Diego, California, 92129

  • West Coast Clinical Research, LLC

    San Ramon, California, 94582

  • Destin Pulmonary Critical Care, PLLS.

    Santa Rosa Beach, Florida, 32459

  • Scottsboro Quick Care Clinic

    Scottsboro, Alabama, 35768

  • North Star Clinical Research, LLC

    Shreveport, Louisiana, 71104

  • Frontier Clinical Research

    Smithfield, Pennsylvania, 15478

  • J. Lewis Research Inc./Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Fusion Clinical Research of Spartanburg

    Spartanburg, South Carolina, 29301

  • Stanford University

    Stanford, California, 94305-5640

  • Tri County Research, Inc.

    Sterling Heights, Michigan, 48310-3503

  • Vita Health and Medical center

    Tamarac, Florida, 33319

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • William Beaumont Hospital

    Troy, Michigan, 48085

  • Arcturus Healthcare PLC

    Troy, Michigan, 48098

  • Preferred Primary Care Physicians Research

    Uniontown, Pennsylvania, 15401

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island, 02886

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20011

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • ClinPoint Trials

    Waxahachie, Texas, 75165

  • Asclepes Research

    Weeki Wachee, Florida, 34607

  • Axcess Medical Research, LLC

    Wellington, Florida, 33414

  • Invocare Clinical Research Center

    West Columbia, South Carolina, 29169

  • Paradigm Clinical Research Centers, Inc.

    Wheat Ridge, Colorado, 80033

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

  • Clinical Trials of America

    Winston-Salem, North Carolina, 27103

  • Southeastern Research Center LLC

    Winston-Salem, North Carolina, 27103

  • Cozy Research, Llc

    Zephyrhills, Florida, 33541

Other trials in United States

South Africa34 sites

  • Cardiology Clinical Research

    Alberton, 1449

  • Josha Research

    Bloemfontein, 9301

  • Dr Dindar & Partner

    Breyten, 2330

  • Endocare Research

    Cape Town, 7646

  • Uhuru Clinical Trial Centre

    Cape Town, 7764

  • Dr EL Janari Private Practice

    Cape Town, 7945

  • Precise Clinical Solutions

    Chatsworth, 4092

  • Abdullah, IA

    Durban, 4001

  • Sebastian, Peter

    Durban, 4001

  • Pillai, P

    Durban, 4068

  • Govind, U

    Durban, 4096

  • Jeevren Reddy, MD

    Durban, 4450

  • Global Clinical Research SA

    Durban North, 4051

  • CRISMO Bertha Gxowa Research Centre

    Johannesburg, 1401

  • Peermed Clinical Trial Centre

    Kempton Park, 1619

  • DJW Research

    Krugersdorp, 1739

  • Aliwal Shoal Medical Centre

    KwaZulu-Natal, 4170

  • Dr A Jacovides Clinical Trials Inc.

    Midrand, 1685

  • Dr AA Mahomed Medical Centre

    Moloto South, 1022

  • Newtown Clinical Research

    Newtown, 2113

  • Pillay, SR

    Ottawa, 4339

  • Smartmed Research Centre

    Port Elizabeth, 6020

  • Emmed Research

    Pretoria, 0084

  • Botho ke Bontle Health Services

    Pretoria, 0101

  • Into Research

    Pretoria, 0181

  • Jongaie Research

    Pretoria, 0183

  • Queenswood Clinical Trial Centre

    Pretoria, 0186

  • Engelbrecht, I

    Pretoria, 157

  • Johese Clinical Research

    Pretoria, 1692

  • Wits Clinical Research

    Soweto, 2013

  • Limpopo Clinical Research Initiative

    Thabazimbi, 380

  • Clinteam Vaal Clinical Trial Centre

    Van Der Bijl, 1911

  • Welkom Clinical Trial Centre

    Welkom, 9460

  • Moriana Clinical Research

    Winnie Mandela, 9400

Other trials in South Africa

Hungary15 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Clinexpert Kft

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

  • Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu

    Budapest, 1122

  • Strázsahegy Medicina Bt

    Budapest, 1171

  • Pestszentimrei Gyermekrendelő

    Budapest, 1188

  • Bugat Pal Korhaz

    Gyöngyös, 3200

  • Futurenest Klinikai Kutato Kft.

    Miskolc, 3527

  • Mohacsi Korhaz

    Mohács, 7700

  • Borbanya Praxis Eu. Kft.

    Nyíregyháza, 4400

  • Medifarma-98 Kft.

    Nyíregyháza, 4400

  • DRC Szentendre

    Szentendre, 2000

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

  • DRC Zamardi

    Zamárdi, 8621

  • DRC Zirc

    Zirc, 8420

Other trials in Hungary

Argentina14 sites

  • Hospital Interzonal General de Agudos Dr. Jose Penna

    Bahía Blanca, B8001DDU

  • CEMIC Saavedra

    Ciudad de Buenos Aires, 1431

  • Hospital Nuestra Señora de la Misericordia

    Córdoba, 5000

  • Hospital Rawson

    Córdoba, 5000

  • Hospital San Roque

    Córdoba, 5000

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Hospital Cordoba

    Córdoba, X5004CDT

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Sanatorio Juan XXIII

    General Roca, 8332

  • Sanatorio del Oeste Ituzaingo

    Ituzaingo, 1714

  • Instituto Medico Platense

    La Plata, B1900AVG

  • Hospital Italiano de La Plata

    La Plata Lpl Lpl, 1900

  • Sanatorio Britanico S.A.

    Rosario, 2000

  • Instituto Del Buen Aire

    Santa Fe, 3000

Other trials in Argentina

India14 sites

  • Rajiv Gandhi Institute of Medical Sciences

    Balaga, 532001

  • M S Ramaiah Memorial Hospital

    Bangalore, 560054

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302001

  • Midland Healthcare & Research Center

    Lucknow, 226006

  • Kasturba Medical College Hospital

    Manipal, 576104

  • Suretech Hospital and Research Centre Limited

    Nagpur, 400012

  • Siddhi Hospital

    Nashik, 422007

  • BLK Super Specialty Hospital

    New Delhi, 110005

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Sahyadri Speciality Hospital

    Pune, 411004

  • Lifepoint Multispecialty Hospital

    Pune, 411023

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • Unique Hospital

    Surat, 395002

  • BAPS Pramukhswami Hospital

    Surat, 395009

Other trials in India

Brazil13 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Infection Control Ltda

    Brasil, 30110-063

  • Hrpc Ulbratech - Ulbra

    Canoas, 92425

  • Centro de Estudos Clínicos do Interior Paulista - CECIP

    Jaú, 17201-150

  • CMIP - Centro Mineiro de Pesquisa Ltda

    Juiz de Fora, 36010 570

  • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

    Rio de Janeiro, 22271-100

  • Pesquisare Saude

    Santo André, 09080-110

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos

    São Bernardo do Campo, 09780-000

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

  • Fundacao Jose Luiz Egydio Setubal

    São Paulo, 01227-200

Other trials in Brazil

South Korea13 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, 220-701

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

  • Inha University Hospital

    Incheon, 22322

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Incheon, 403-720

  • Dong-A University Hospital

    Pusan, 602-715

  • Korea University Anam Hospital

    Seoul, 02841

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Korea University Guro Hospital

    Seoul, 8308

  • The Catholic university of Korea ST Vincent Hospital

    Suwon, 16247

Other trials in South Korea

Latvia11 sites

  • Liga Kozlovska family doctor practice

    Balvi, LV4501

  • OLVI Medical Centre

    Daugavpils, LV-5401

  • Baiba Bake GP practice

    Jelgava, LV3001

  • Ruta Eglite's Private Practice

    Kuldīga, LV-3301

  • Inese Cebere GP practice

    Liepāja, LV-3401

  • S. Boreiko Doctor's Practice

    Ogre, LV-5001

  • Children's Clinical University Hospital

    Riga, LV-1004

  • Clinic of GP A.Lasmanis 'ALMA'

    Riga, LV-1010

  • Health Centre 4

    Riga, LV-1012

  • Inese Petrova General Practitioner Practice

    Tukums, LV-3101

  • Medical Practice BINI

    Ventspils, LV3601

Other trials in Latvia

Bulgaria10 sites

  • SHATPPD - Ruse Ltd.

    Rousse, 7002

  • MHAT Knyaginya Klementina

    Sofia, 1233

  • MHAT 'Lyulin' EAD

    Sofia, 1336

  • Acibadem City Clinic Tokuda Hospital

    Sofia, 1407

  • DCC II- Sofia EOOD

    Sofia, 1606

  • Medical Center 'N. I. Pirogov', EOOD

    Sofia, 1606

  • Medical Center Excelsior OOD

    Sofia, 1606

  • Military Medical Academy - Sofia

    Sofia, 1606

  • MHAT Dr Stefan Cherkezov

    Veliko Tarnovo, 5000

  • MC 'Sv. Ivan Rilski', OOD

    Vidin, 3700

Other trials in Bulgaria

Russia10 sites

  • Institute Of Epidimiology And Microbiology

    Kazan', 420015

  • Limited Liability company 'MSMC' Euromed

    Omsk, 644024

  • LLC Outpatient department of Private Security Guards and Detectives

    Saint Petersburg, 192007

  • LLC Institute of Medical Examinations

    Saint Petersburg, 196084

  • LLC Kurator

    Saint Petersburg, 196240

  • FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF

    Saint Petersburg, 197376

  • LLC 'ArsVite'

    Stavropol, 355020

  • Siberian State Medical University

    Tomsk, 634061

  • Clinical Hospital #3

    Yaroslavl, 150007

  • SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF

    Yaroslavl, 150010

Other trials in Russia

Spain10 sites

  • Hosp. Gral. Univ. de Elche

    Elche, 03203

  • Hosp. Univ. San Cecilio

    Granada, 18012

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Hm Monteprincipe

    Madrid, 28660

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Alvaro Cunqueiro

    Vigo, 36213

Other trials in Spain

Belgium9 sites

  • CHU Saint-Pierre

    Brussels, 1000

  • Hopital Erasme

    Brussels, 1070

  • Institut Jules Bordet

    Brussels, 1070

  • De Meulemeester, Marc

    Gozée, 6534

  • Jaak Mortelmans

    Ham, 3945

  • Quartier du Furgy 4

    Herbeumont, 6887

  • Research Link

    Linkebeek, 1630

  • BVBA Dr. Luc Capiau

    Massemen, 9230

  • Testumed

    Tessenderlo, 3980

Other trials in Belgium

Lithuania9 sites

  • Auki Sveikas

    Kaunas, 44175

  • Silainiai Family Health Center, JSC

    Kaunas, 48259

  • Saules Seimos Medicinos Centras, JSC

    Kaunas, 49449

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, 76231

  • Inlita, JSC, Lazdynai KTC clinical trial site

    Vilnius, 4130

  • Central Outpatient Clinic

    Vilnius, LT-01117

  • Inlita, JSC

    Vilnius, LT-08406

  • Vilnius University Hospital Santaros Klinikos, Public Institution

    Vilnius, LT-08661

Other trials in Lithuania

Mexico9 sites

  • Hospital Cardiologica Aguascalientes

    Aguascalientes, 20230

  • Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.

    Culiacán, 80230

  • Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

    Guadalajara, 44130

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Hospital Civil de Guadalajara Dr. Juan I. Menchaca

    Guadalajara, 44340

  • Centro Medico Jojutla

    Jojutla, 62900

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 6720

  • Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

    Monterrey, 64460

  • Clinical Trials Mexico S.A. de C.V.

    Pahucha, 42070

Other trials in Mexico

France8 sites

  • Centre Hospitalier d'Agen

    Agen, 47923

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • Centre Hospitalier Départemental

    La Roche S/ Yon Cedex 9, 85925

  • CHU de Grenoble Hopital Albert Michallon

    La Tronche, 38043

  • CHU Nantes - Hotel Dieu

    Nantes, 44093

  • CHU De Nice Hopital De l'Archet

    Nice, 06202

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Cochin

    Paris, 75679 Cedex 14

Other trials in France

Canada7 sites

  • Aggarwal and associates Ltd

    Brampton, Ontario, L6T 0G1

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • SKDS Research Inc.

    Newmarket, Ontario, L3Y 5G8

  • Recherche Clinique Sigma Inc.

    Québec, Quebec, G1G 4A2

  • The Bailey Clinic

    Red Deer, Alberta, T4N 6V7

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Dr. Anil K Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

Other trials in Canada

Germany7 sites

  • Universitaetsklinikum Koelnt

    Cologne, 50937

  • MECS GmbH Cottbus

    Cottbus, 03050

  • Jung, Thomas

    Deggingen, 73326

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Giessen und Marburg GmbH

    Giessen, 35392

  • Gemeinschaftspraxis Dr. Klein/ Minnich

    Künzing, 94550

  • Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

    Leipzig, 04249

Other trials in Germany

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Adnan Menderes University

    Aydin, 09100

  • Uludag University Medical Faculty

    Bursa, 16059

  • Diyarbakir University Medical Faculty

    Diyarbakır, 21080

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Hacettepe University Medical Faculty

    Samanpazarı, 06100

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61080

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Czechia6 sites

  • ADMED s.r.o.

    České Budějovice, 37006

  • Sanare, s.r.o.

    České Budějovice, 37006

  • Nemocnice Kyjov, p.o.

    Kyjov, 697 01

  • Praktik Pb s.r.o

    Příbram, 26101

  • SARKAMED s.r.o.

    Slaný, 274 01

  • Prakticky lekar

    Sokolov, 356 01

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Estonia6 sites

  • Private GP Ilme Last

    Paide, 72712

  • Vee Family Doctor's Center OY

    Paide, 72713

  • OU Innomedica

    Tallinn, 10117

  • Merelahe Family Doctors Center

    Tallinn, 10617

  • Pirita Family Doctors Centre

    Tallinn, 11911

  • Family Doctors Pullerits & Gavronski

    Tartu, 51014

Other trials in Estonia

Israel6 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Bnai Zion Medical Center

    Haifa, 31048

  • Galilee Medical Center

    Nahariya, 22100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 7610001

  • Ziv Medical Center

    Safed, 13100

Other trials in Israel

Poland6 sites

  • Malopolskie Centrum Alergologii

    Krakow, 31-624

  • Centrum Medyczne w Lancucie Sp.z o.o.

    Łańcut, 37-100

  • ETG Lodz

    Lodz, 90 302

  • Powiatowe Centrum Medyczne w Wolowie Sp z o o

    Specjalistyczna W Brzegu Dolnym, 58 120

  • Gabinet Lekarski Pediatryczno-Alergologiczny

    Sucha Beskidzka, 34-200

  • NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, 51 162

Other trials in Poland

China5 sites

  • Chinese PLA General Hospital

    Beijing, 100853

  • Fuzhou General Hospital of Nanjing Military Command

    Fuzhou, 350000

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

  • Wuxi People s Hospital

    Wuxi, 214000

  • Henan Provincial Peoples Hospital

    Zhengzhou

Other trials in China

Peru5 sites

  • Complejo Hospitalario San Pablo

    Lima, 33

  • Clínica Sanna San Borja

    Lima, 41

  • Clínica Internacional

    Lima, Lima 01

  • Hospital Maria Auxiliadora

    Lima, LIMA 29

  • Clinica Peruano Americana S.A

    Trujillo, 13007

Other trials in Peru

Taiwan5 sites

  • Taipei Medical University Shuang-Ho Hospital

    New Taipei City, 23561

  • Kuang Tien General Hospital, Shalu

    Taichung

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University

    Taipei, 110

  • Taipei Medical University-Wan Fang Hospital

    Taipei, 116

Other trials in Taiwan

Thailand5 sites

  • The Hospital for Tropical Diseases

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Srinagarind Hospital

    Muang, 40002

  • Bamrasnaradura Infectious Disease Institute

    Nonthaburi, 11000

  • Bumrungrad Hospital

    Wattana, 10110

Other trials in Thailand

Ukraine5 sites

  • Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE

    Kharkiv, 61106

  • Kyiv Oleksandrivska Clinical Hospital

    Kyiv, 1601

  • Odesa City Municipal Institution Polyclinic #20

    Odesa, 65114

  • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

    Poltava, 36000

  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

    Vinnytsia, 21021

Other trials in Ukraine

United Kingdom5 sites

  • Swan Lane Medical Centre

    Bolton, BL 6 6QT

  • Bodey Medical Centre

    Manchester, M14 6WP

  • Barlow Medical Centre

    Manchester, M20 2RN

  • West Timperley Medical Centre

    Manchester, WA14 5PF

  • Northenden Group Practice

    Northenden, M22 4DH

Other trials in United Kingdom

Italy4 sites

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AOU Policlinico di Modena

    Modena, 41124

  • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

    Monza, 20052

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Malaysia4 sites

  • Klinik Kesihatan Cheras Baru

    Cheras Baru, 56100

  • Klinik Kesihatan Kuang

    Kuang, 48050

  • Hospital Miri

    Miri, 98000

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

New Zealand4 sites

  • Southern Clinical Trials Ltd

    Auckland, 1050

  • Culloden Research Ltd

    Papamoa, 3118

  • Lakeland Family Medical Services Ltd

    Rotorua, 3010

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Slovakia4 sites

  • Alersa, S.R.O.

    Košice, 04022

  • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.

    Michalovce, 07101

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 05201

  • Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

    Svidník, 08901

Other trials in Slovakia

Sweden4 sites

  • Department for Heart Failure and Valvular Disease

    Malmö, 205 02

  • City Diabetes

    Stockholm, 11157

  • Norrlands Universitetssjukhus

    Umeå, 901 87

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Chile3 sites

  • Hospital El Pino

    San Bernardo, 13560

  • Centro de Investigacion del Maule

    Talca, 00000

  • Hospital de Niños y Cunas

    Viña

Other trials in Chile

Netherlands3 sites

  • Huisartsenpraktijk Zijtregtop

    Rotterdam, 3037 AN

  • Huisartsenpraktijk Mangal

    The Hague, 2565 KV

  • Huisartsenpraktijk Top

    Zwijndrecht, 3334 SB

Other trials in Netherlands

Vietnam3 sites

  • Bach Mai Hospital

    Hanoi, 100000

  • National Hospital for Tropical Diseases

    Hanoi, 100000

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City

Other trials in Vietnam

Australia2 sites

  • Northside Health

    Coffs Harbour, 2450

  • Mater Hospital Brisbane

    South Brisbane, 4101

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Austria2 sites

  • AKH - Medizinische Universitat Wien

    Vienna, 1090

  • SMZ Süd - Kaiser Franz Josef Spital Wien

    Vienna, 1100

Other trials in Austria

About this study

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

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.

Read the 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.

Conditions
Influenza A
Being tested
Pimodivir 600 mg, Placebo, SOC Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pimodivir 600 mgDrug

    Also called JNJ-63623872

    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).

  • PlaceboDrug

    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).

  • SOC TreatmentOther

    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).

Study groups in NCT03381196
Study groupRoleWhat they receive
Treatment Arm 1 (pimodivir + SOC treatment)ExperimentalParticipants 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).
Receives: Drug: Pimodivir 600 mg; Other: SOC Treatment
Treatment Arm 2 (placebo + SOC treatment)Placebo comparatorParticipants 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.
Receives: Drug: Placebo; Other: SOC Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Day 28

Secondary outcomes (8)

  1. Number of Participants Hospitalized After Treatment Initiation

    The number of participants hospitalized after treatment initiation were reported.

    Measured: Up to Day 28

  2. 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.

    Measured: Baseline, Day 3, 6, 10, 14

  3. 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).

    Measured: Up to Day 28

  4. Plasma Concentration of Pimodivir

    Plasma concentration of Pimodivir was reported.

    Measured: Day 3, 6, 7

  5. 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.

    Measured: Up to Day 28

  6. 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.

    Measured: Up to Day 28

  7. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)

    Number of participants with clinically significant changes in Electrocardiogram (ECG) were reported.

    Measured: Up to Day 28

  8. 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.

    Measured: Up to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2017
  2. Study start21 Jan 2018
  3. Primary completion28 May 2020
  4. Study completion24 Aug 2020

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
553 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03381196
Sponsor's protocol ID
CR108400
Other IDs
2017-002217-59, 63623872FLZ3002, 2017
Status last verified
Jan 2025
First submitted
18 Dec 2017
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

  • Leopold L, Vingerhoets J, Deleu S, Nalpas C, Weber K, van Dromme I, Lowson D, Michiels B, van Duijnhoven W. Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection. J Infect Dis. 2025 Feb 4;231(1):e132-e143. doi: 10.1093/infdis/jiae408.

    PubMed 39172627

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimodivir 600 mg and SOC Treatment in people with Influenza A, run by Janssen Research & Development, LLC at 427 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 427 sites in United States, South Africa, Hungary, Argentina, India and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03381196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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