Study 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.
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 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
3 other identifiers
interventional
553
36 countries
415
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2018
Typical duration for phase_3
415 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
January 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2020
CompletedResults Posted
Study results publicly available
May 24, 2021
CompletedFebruary 4, 2025
January 1, 2025
2.4 years
December 18, 2017
April 30, 2021
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
Up to Day 28
Secondary Outcomes (8)
Number of Participants Hospitalized After Treatment Initiation
Up to Day 28
Viral Load Over Time
Baseline, Day 3, 6, 10, 14
Number of Participants With Emergence of Viral Resistance to Pimodivir
Up to Day 28
Plasma Concentration of Pimodivir
Day 3, 6, 7
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Up to Day 28
- +3 more secondary outcomes
Study Arms (2)
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).
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.
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (427)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Cahaba Research Inc
Birmingham, Alabama, 35242, United States
Scottsboro Quick Care Clinic
Scottsboro, Alabama, 35768, United States
SC Clinical Research Inc.
California City, California, 92844, United States
Research Center of Fresno Inc
Fresno, California, 93702, United States
Allied Clinical Research
Gold River, California, 95670, United States
Innovative Clinical Research Inc
Harbor City, California, 90710, United States
Om Research LLC
Lancaster, California, 93534, United States
Ark Clinical Research
Long Beach, California, 90806, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Downtown LA Research Center, Inc
Los Angeles, California, 90017, United States
California Allergy & Asthma Medical Group Inc.
Los Angeles, California, 90025, United States
Adam D. Karns, MD
Los Angeles, California, 90036, United States
Lucita M. Cruz Md Inc
Norwalk, California, 90650, United States
Asclepes Research
Panorama City, California, 91402, United States
Center for Clinical Trials LLC
Paramount, California, 90723, United States
Benchmark Research
Sacramento, California, 95684, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
San Diego Sports Medicine & Family Health Center
San Diego, California, 92129, United States
West Coast Clinical Research, LLC
San Ramon, California, 94582, United States
Stanford University
Stanford, California, 94305-5640, United States
Lynn Institute
Colorado Springs, Colorado, 80920, United States
Complete Family Care
Northglenn, Colorado, 80234, United States
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, 80033, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20011, United States
Moonshine Research Center, Inc
Doral, Florida, 33166, United States
Best Quality Research Inc
Hialeah, Florida, 33016, United States
Floridian Clinical Research LLC
Hialeah, Florida, 33016, United States
The community Research of South Florida
Hialeah, Florida, 33016, United States
Encore Medical Research, LLC
Hollywood, Florida, 46112, United States
Homestead Associates in Research Inc
Homestead, Florida, 33032, United States
Care Partners Clinical Research
Jacksonville, Florida, 32218, United States
Premier Medical Group
Lady Lake, Florida, 32159, United States
Sima Research Clinic
Miami, Florida, 33125, United States
Universal Clinical Research Associates
Miami, Florida, 33134, United States
South Florida Research Center Inc.
Miami, Florida, 33135, United States
A Plus Research
Miami, Florida, 33144, United States
Nuren Medical & Research Center
Miami, Florida, 33144, United States
Coral Research Clinic Corp
Miami, Florida, 33175, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Vista Health Research, LLC
Miami, Florida, 33176, United States
Crystal Biomedical Research
Miami Lakes, Florida, 33014, United States
Combined Research Orlando
Orlando, Florida, 32803, United States
Clinical NeuroScience Solutions Inc
Orlando, Florida, 32806, United States
Omega Research Consultants
Orlando, Florida, 32810, United States
Pines Care Research Center Inc
Pembroke Pines, Florida, 33026, United States
South Broward Research, LLC
Pembroke Pines, Florida, 33027, United States
Destin Pulmonary Critical Care, PLLS.
Santa Rosa Beach, Florida, 32459, United States
Vita Health and Medical center
Tamarac, Florida, 33319, United States
Asclepes Research
Weeki Wachee, Florida, 34607, United States
Axcess Medical Research, LLC
Wellington, Florida, 33414, United States
Cozy Research, Llc
Zephyrhills, Florida, 33541, United States
Snake River Research, PLLC
Idaho Falls, Idaho, 83404, United States
Saltzer Medical Group
Nampa, Idaho, 83686, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Investigators Research Group, LLC
Brownsburg, Indiana, 46112, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714, United States
Hutchinson Clinic
Hutchinson, Kansas, 67502, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503, United States
Clinical Trials Management, LLC
Metairie, Louisiana, 70006, United States
Medpharmics, LLC
Metairie, Louisiana, 70006, United States
North Star Clinical Research, LLC
Shreveport, Louisiana, 71104, United States
University Of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21218, United States
Centennial Medical Group
Elkridge, Maryland, 21075, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Wayne State Univ School of Medicine
Detroit, Michigan, 48201, United States
Wayne State University
Detroit, Michigan, 97205, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Tri County Research, Inc.
Sterling Heights, Michigan, 48310-3503, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Arcturus Healthcare PLC
Troy, Michigan, 48098, United States
Craig A. Spiegel, MD
Bridgeton, Missouri, 63044, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Montana Medical Research
Missoula, Montana, 59808, United States
Barrett Clinic P.C.
La Vista, Nebraska, 68128, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Next Phase Research Alliance
Las Vegas, Nevada, 89119, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
Accellacare Research of Cary
Cary, North Carolina, 27518, United States
Onsite Clinical Solutions
Clemmons, North Carolina, 27012, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28304, United States
clinical research of Gastonia
Gastonia, North Carolina, 28054, United States
Hickory Research Center.
Hickory, North Carolina, 28601, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Burke Primary Care
Morganton, North Carolina, 28655, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Clinical Trials of America
Winston-Salem, North Carolina, 27103, United States
Southeastern Research Center LLC
Winston-Salem, North Carolina, 27103, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Buckeye Health and Research, LLC
Hilliard, Ohio, 43027, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 29720, United States
Detweiler Family Medicine and Associates
Lansdale, Pennsylvania, 19446, United States
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141, United States
Preferred Primary Care Physicians Research
Pittsburgh, Pennsylvania, 15236, United States
Frontier Clinical Research
Smithfield, Pennsylvania, 15478, United States
Preferred Primary Care Physicians Research
Uniontown, Pennsylvania, 15401, United States
AAPRI Clinical Research Institute
Warwick, Rhode Island, 02886, United States
Spectrum Medical Research
Gaffney, South Carolina, 29341, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29651, United States
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464, United States
Fusion Clinical Research of Spartanburg
Spartanburg, South Carolina, 29301, United States
Invocare Clinical Research Center
West Columbia, South Carolina, 29169, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
PMG Research of Bristol
Bristol, Tennessee, 37620, United States
PMG Research of Knoxville
Jefferson City, Tennessee, 37760, United States
PMG Research of Knoxville
Knoxville, Tennessee, 37912, United States
HIRG, LLC dba Health Innovation Research Group
Arlington, Texas, 76014, United States
ACRC Trials
Austin, Texas, 78735, United States
Family Medicine Associates of Texas
Carrollton, Texas, 75010, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
WR-Global Medical Research, LLC
DeSoto, Texas, 75115, United States
University Of Texas Medical Branch At Galveston
Galveston, Texas, 77555, United States
San Gabriel Clinical Research, LLC
Georgetown, Texas, 78626, United States
BI Research Center
Houston, Texas, 77043, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
Northwest Med Care,P.A.
Houston, Texas, 77070, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Dairy Ashford Family Practice
Houston, Texas, 77077, United States
JM Research.PLLC
Houston, Texas, 77083, United States
PCP for Life
Houston, Texas, 77093-6731, United States
SMS Clinical Research LLC
Mesquite, Texas, 75149, United States
Village Health Partners
Plano, Texas, 75024, United States
Tekton Research Inc.
San Antonio, Texas, 78240, United States
DM Clinical Research
San Antonio, Texas, 78249, United States
Renovatio Clinical
The Woodlands, Texas, 77380, United States
ClinPoint Trials
Waxahachie, Texas, 75165, United States
Val Hansen
Bountiful, Utah, 84010, United States
Ericksen Research and Development
Clinton, Utah, 84015, United States
J. Lewis research Inc./ Foothill Family Clinic South
Draper, Utah, 84020, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Granger Medical Clinic-Riverton
Riverton, Utah, 84065, United States
J. Lewis research Inc./ Foothill Family Care
Salt Lake City, Utah, 84109, United States
J. Lewis research Inc./ Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
J. Lewis Research Inc/ FirstMed East
Salt Lake City, Utah, 84121, United States
J. Lewis Research Inc./Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Millennium Clinical Trials LLC
Arlington, Virginia, 22203, United States
Hospital Interzonal General de Agudos Dr. Jose Penna
Bahía Blanca, B8001DDU, Argentina
CEMIC Saavedra
Ciudad de Buenos Aires, 1431, Argentina
Hospital Nuestra Señora de la Misericordia
Córdoba, 5000, Argentina
Hospital Rawson
Córdoba, 5000, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Hospital Cordoba
Córdoba, X5004CDT, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Sanatorio Juan XXIII
General Roca, 8332, Argentina
Sanatorio del Oeste Ituzaingo
Ituzaingó, 1714, Argentina
Instituto Medico Platense
La Plata, B1900AVG, Argentina
Hospital Italiano de La Plata
La Plata Lpl Lpl, 1900, Argentina
Sanatorio Britanico S.A.
Rosario, 2000, Argentina
Instituto Del Buen Aire
Santa Fe, 3000, Argentina
Northside Health
Coffs Harbour, 2450, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
AKH - Medizinische Universitat Wien
Vienna, 1090, Austria
SMZ Süd - Kaiser Franz Josef Spital Wien
Vienna, 1100, Austria
CHU Saint-Pierre
Brussels, 1000, Belgium
Hopital Erasme
Brussels, 1070, Belgium
Institut Jules Bordet
Brussels, 1070, Belgium
De Meulemeester, Marc
Gozée, 6534, Belgium
Jaak Mortelmans
Ham, 3945, Belgium
Quartier du Furgy 4
Herbeumont, 6887, Belgium
Research Link
Linkebeek, 1630, Belgium
BVBA Dr. Luc Capiau
Massemen, 9230, Belgium
Testumed
Tessenderlo, 3980, Belgium
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Infection Control Ltda
Brasil, 30110-063, Brazil
Hrpc Ulbratech - Ulbra
Canoas, 92425, Brazil
Centro de Estudos Clínicos do Interior Paulista - CECIP
Jaú, 17201-150, Brazil
CMIP - Centro Mineiro de Pesquisa Ltda
Juiz de Fora, 36010 570, Brazil
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
Rio de Janeiro, 22271-100, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, 09780-000, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020, Brazil
Fundacao Jose Luiz Egydio Setubal
São Paulo, 01227-200, Brazil
SHATPPD - Ruse Ltd.
Rousse, 7002, Bulgaria
MHAT Knyaginya Klementina
Sofia, 1233, Bulgaria
MHAT 'Lyulin' EAD
Sofia, 1336, Bulgaria
Acibadem City Clinic Tokuda Hospital
Sofia, 1407, Bulgaria
DCC II- Sofia EOOD
Sofia, 1606, Bulgaria
Medical Center 'N. I. Pirogov', EOOD
Sofia, 1606, Bulgaria
Medical Center Excelsior OOD
Sofia, 1606, Bulgaria
Military Medical Academy - Sofia
Sofia, 1606, Bulgaria
MHAT Dr Stefan Cherkezov
Veliko Tarnovo, 5000, Bulgaria
MC 'Sv. Ivan Rilski', OOD
Vidin, 3700, Bulgaria
The Bailey Clinic
Red Deer, Alberta, T4N 6V7, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Aggarwal and associates Ltd
Brampton, Ontario, L6T 0G1, Canada
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4, Canada
Recherche Clinique Sigma Inc.
Québec, Quebec, G1G 4A2, Canada
Hospital El Pino
San Bernardo, 13560, Chile
Centro de Investigacion del Maule
Talca, 00000, Chile
Hospital de Niños y Cunas
Viña, Chile
Chinese PLA General Hospital
Beijing, 100853, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, 350000, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Wuxi People s Hospital
Wuxi, 214000, China
Henan Provincial Peoples Hospital
Zhengzhou, China
ADMED s.r.o.
České Budějovice, 37006, Czechia
Sanare, s.r.o.
České Budějovice, 37006, Czechia
Nemocnice Kyjov, p.o.
Kyjov, 697 01, Czechia
Praktik Pb s.r.o
Příbram, 26101, Czechia
SARKAMED s.r.o.
Slaný, 274 01, Czechia
Prakticky lekar
Sokolov, 356 01, Czechia
Private GP Ilme Last
Paide, 72712, Estonia
Vee Family Doctor's Center OY
Paide, 72713, Estonia
OU Innomedica
Tallinn, 10117, Estonia
Merelahe Family Doctors Center
Tallinn, 10617, Estonia
Pirita Family Doctors Centre
Tallinn, 11911, Estonia
Family Doctors Pullerits & Gavronski
Tartu, 51014, Estonia
Centre Hospitalier d'Agen
Agen, 47923, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
Centre Hospitalier Départemental
La Roche S/ Yon Cedex 9, 85925, France
CHU de Grenoble Hopital Albert Michallon
La Tronche, 38043, France
CHU Nantes - Hotel Dieu
Nantes, 44093, France
CHU De Nice Hopital De l'Archet
Nice, 06202, France
Hôpital Bichat - Claude Bernard
Paris, 75018, France
Hopital Cochin
Paris, 75679 Cedex 14, France
Universitaetsklinikum Koelnt
Cologne, 50937, Germany
MECS GmbH Cottbus
Cottbus, 03050, Germany
Jung, Thomas
Deggingen, 73326, Germany
Universitaetsklinik Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, 35392, Germany
Gemeinschaftspraxis Dr. Klein/ Minnich
Künzing, 94550, Germany
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
Leipzig, 04249, Germany
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, 8230, Hungary
Clinexpert Kft
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Eszak Kozep budai Centrum Uj Szent Janos Korhaz es Szakrendelo Budai Csaladkozpontu
Budapest, 1122, Hungary
Strázsahegy Medicina Bt
Budapest, 1171, Hungary
Pestszentimrei Gyermekrendelő
Budapest, 1188, Hungary
Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Futurenest Klinikai Kutato Kft.
Miskolc, 3527, Hungary
Mohacsi Korhaz
Mohács, 7700, Hungary
Borbanya Praxis Eu. Kft.
Nyíregyháza, 4400, Hungary
Medifarma-98 Kft.
Nyíregyháza, 4400, Hungary
DRC Szentendre
Szentendre, 2000, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
DRC Zamardi
Zamárdi, 8621, Hungary
DRC Zirc
Zirc, 8420, Hungary
Rajiv Gandhi Institute of Medical Sciences
Balaga, 532001, India
M S Ramaiah Memorial Hospital
Bangalore, 560054, India
S. R. Kalla Memorial General Hospital
Jaipur, 302001, India
Midland Healthcare & Research Center
Lucknow, 226006, India
Kasturba Medical College Hospital
Manipal, 576104, India
Suretech Hospital and Research Centre Limited
Nagpur, 400012, India
Siddhi Hospital
Nashik, 422007, India
BLK Super Specialty Hospital
New Delhi, 110005, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Sahyadri Speciality Hospital
Pune, 411004, India
Lifepoint Multispecialty Hospital
Pune, 411023, India
Shree Giriraj Multispeciality Hospital
Rajkot, 360005, India
Unique Hospital
Surat, 395002, India
BAPS Pramukhswami Hospital
Surat, 395009, India
Barzilai Medical Center
Ashkelon, 78278, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Ziv Medical Center
Safed, 13100, Israel
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
Monza, 20052, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Liga Kozlovska family doctor practice
Balvi, LV4501, Latvia
OLVI Medical Centre
Daugavpils, LV-5401, Latvia
Baiba Bake GP practice
Jelgava, LV3001, Latvia
Ruta Eglite's Private Practice
Kuldīga, LV-3301, Latvia
Inese Cebere GP practice
Liepāja, LV-3401, Latvia
S. Boreiko Doctor's Practice
Ogre, LV-5001, Latvia
Children's Clinical University Hospital
Riga, LV-1004, Latvia
Clinic of GP A.Lasmanis 'ALMA'
Riga, LV-1010, Latvia
Health Centre 4
Riga, LV-1012, Latvia
Inese Petrova General Practitioner Practice
Tukums, LV-3101, Latvia
Medical Practice BINI
Ventspils, LV3601, Latvia
Auki Sveikas
Kaunas, 44175, Lithuania
Silainiai Family Health Center, JSC
Kaunas, 48259, Lithuania
Saules Seimos Medicinos Centras, JSC
Kaunas, 49449, Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50009, Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, 76231, Lithuania
Inlita, JSC, Lazdynai KTC clinical trial site
Vilnius, 4130, Lithuania
Central Outpatient Clinic
Vilnius, LT-01117, Lithuania
Inlita, JSC
Vilnius, LT-08406, Lithuania
Vilnius University Hospital Santaros Klinikos, Public Institution
Vilnius, LT-08661, Lithuania
Klinik Kesihatan Cheras Baru
Cheras Baru, 56100, Malaysia
Klinik Kesihatan Kuang
Kuang, 48050, Malaysia
Hospital Miri
Miri, 98000, Malaysia
Hospital Taiping
Taiping, 34000, Malaysia
Hospital Cardiologica Aguascalientes
Aguascalientes, 20230, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C.
Culiacán, 80230, Mexico
Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA
Guadalajara, 44130, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, 44340, Mexico
Centro Medico Jojutla
Jojutla, 62900, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, 6720, Mexico
Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'
Monterrey, 64460, Mexico
Clinical Trials Mexico S.A. de C.V.
Pahucha, 42070, Mexico
Huisartsenpraktijk Zijtregtop
Rotterdam, 3037 AN, Netherlands
Huisartsenpraktijk Mangal
The Hague, 2565 KV, Netherlands
Huisartsenpraktijk Top
Zwijndrecht, 3334 SB, Netherlands
Southern Clinical Trials Ltd
Auckland, 1050, New Zealand
Culloden Research Ltd
Papamoa, 3118, New Zealand
Lakeland Family Medical Services Ltd
Rotorua, 3010, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Complejo Hospitalario San Pablo
Lima, 33, Peru
Clínica Sanna San Borja
Lima, 41, Peru
Clínica Internacional
Lima, Lima 01, Peru
Hospital Maria Auxiliadora
Lima, LIMA 29, Peru
Clinica Peruano Americana S.A
Trujillo, 13007, Peru
Malopolskie Centrum Alergologii
Krakow, 31-624, Poland
ETG Lodz
Lodz, 90 302, Poland
Powiatowe Centrum Medyczne w Wolowie Sp z o o
Specjalistyczna W Brzegu Dolnym, 58 120, Poland
Gabinet Lekarski Pediatryczno-Alergologiczny
Sucha Beskidzka, 34-200, Poland
NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, 51 162, Poland
Centrum Medyczne w Lancucie Sp.z o.o.
Łańcut, 37-100, Poland
Institute Of Epidimiology And Microbiology
Kazan', 420015, Russia
Limited Liability company 'MSMC' Euromed
Omsk, 644024, Russia
LLC Outpatient department of Private Security Guards and Detectives
Saint Petersburg, 192007, Russia
LLC Institute of Medical Examinations
Saint Petersburg, 196084, Russia
LLC Kurator
Saint Petersburg, 196240, Russia
FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF
Saint Petersburg, 197376, Russia
LLC 'ArsVite'
Stavropol, 355020, Russia
Siberian State Medical University
Tomsk, 634061, Russia
Clinical Hospital #3
Yaroslavl, 150007, Russia
SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF
Yaroslavl, 150010, Russia
Alersa, S.R.O.
Košice, 04022, Slovakia
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
Michalovce, 07101, Slovakia
Plucna ambulancia Hrebenar, s.r.o.
Spišská Nová Ves, 05201, Slovakia
Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
Svidník, 08901, Slovakia
Cardiology Clinical Research
Alberton, 1449, South Africa
Josha Research
Bloemfontein, 9301, South Africa
Dr Dindar & Partner
Breyten, 2330, South Africa
Endocare Research
Cape Town, 7646, South Africa
Uhuru Clinical Trial Centre
Cape Town, 7764, South Africa
Dr EL Janari Private Practice
Cape Town, 7945, South Africa
Precise Clinical Solutions
Chatsworth, 4092, South Africa
Abdullah, IA
Durban, 4001, South Africa
Sebastian, Peter
Durban, 4001, South Africa
Pillai, P
Durban, 4068, South Africa
Govind, U
Durban, 4096, South Africa
Jeevren Reddy, MD
Durban, 4450, South Africa
Global Clinical Research SA
Durban North, 4051, South Africa
CRISMO Bertha Gxowa Research Centre
Johannesburg, 1401, South Africa
Peermed Clinical Trial Centre
Kempton Park, 1619, South Africa
DJW Research
Krugersdorp, 1739, South Africa
Aliwal Shoal Medical Centre
KwaZulu-Natal, 4170, South Africa
Dr A Jacovides Clinical Trials Inc.
Midrand, 1685, South Africa
Dr AA Mahomed Medical Centre
Moloto South, 1022, South Africa
Newtown Clinical Research
Newtown, 2113, South Africa
Pillay, SR
Ottawa, 4339, South Africa
Smartmed Research Centre
Port Elizabeth, 6020, South Africa
Emmed Research
Pretoria, 0084, South Africa
Botho ke Bontle Health Services
Pretoria, 0101, South Africa
Into Research
Pretoria, 0181, South Africa
Jongaie Research
Pretoria, 0183, South Africa
Queenswood Clinical Trial Centre
Pretoria, 0186, South Africa
Engelbrecht, I
Pretoria, 157, South Africa
Johese Clinical Research
Pretoria, 1692, South Africa
Wits Clinical Research
Soweto, 2013, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, 380, South Africa
Clinteam Vaal Clinical Trial Centre
Van Der Bijl, 1911, South Africa
Welkom Clinical Trial Centre
Welkom, 9460, South Africa
Moriana Clinical Research
Winnie Mandela, 9400, South Africa
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 220-701, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450, South Korea
Inha University Hospital
Incheon, 22322, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 403-720, South Korea
Dong-A University Hospital
Pusan, 602-715, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Korea University Guro Hospital
Seoul, 8308, South Korea
The Catholic university of Korea ST Vincent Hospital
Suwon, 16247, South Korea
Hosp. Gral. Univ. de Elche
Elche, 03203, Spain
Hosp. Univ. San Cecilio
Granada, 18012, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Hm Monteprincipe
Madrid, 28660, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Alvaro Cunqueiro
Vigo, 36213, Spain
Department for Heart Failure and Valvular Disease
Malmo, 205 02, Sweden
City Diabetes
Stockholm, 11157, Sweden
Norrlands Universitetssjukhus
Umeå, 901 87, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Taipei Medical University Shuang-Ho Hospital
New Taipei City, 23561, Taiwan
Kuang Tien General Hospital, Shalu
Taichung, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Medical University
Taipei, 110, Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
The Hospital for Tropical Diseases
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Bamrasnaradura Infectious Disease Institute
Nonthaburi, 11000, Thailand
Bumrungrad Hospital
Wattana, 10110, Thailand
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Adnan Menderes University
Aydin, 09100, Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, 16059, Turkey (Türkiye)
Diyarbakir University Medical Faculty
Diyarbakır, 21080, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Hacettepe University Medical Faculty
Samanpazarı, 06100, Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, 61080, Turkey (Türkiye)
Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE
Kharkiv, 61106, Ukraine
Kyiv Oleksandrivska Clinical Hospital
Kyiv, 1601, Ukraine
Odesa City Municipal Institution Polyclinic #20
Odesa, 65114, Ukraine
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava, 36000, Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21021, Ukraine
Swan Lane Medical Centre
Bolton, BL 6 6QT, United Kingdom
Bodey Medical Centre
Manchester, M14 6WP, United Kingdom
Barlow Medical Centre
Manchester, M20 2RN, United Kingdom
West Timperley Medical Centre
Manchester, WA14 5PF, United Kingdom
Northenden Group Practice
Northenden, M22 4DH, United Kingdom
Bach Mai Hospital
Hanoi, 100000, Vietnam
National Hospital for Tropical Diseases
Hanoi, 100000, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, Vietnam
Related Publications (1)
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.
PMID: 39172627DERIVED
MeSH Terms
Interventions
Limitations and Caveats
As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters.
Results Point of Contact
- Title
- Senior Director Medical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 18, 2017
First Posted
December 21, 2017
Study Start
January 21, 2018
Primary Completion
May 28, 2020
Study Completion
August 24, 2020
Last Updated
February 4, 2025
Results First Posted
May 24, 2021
Record last verified: 2025-01