A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection

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.

Study Overview

• Status: Terminated
• Conditions: Influenza A
• Intervention / Treatment: Drug: Pimodivir 600 mg; Other: SOC Treatment; Drug: Placebo

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, adult, and elderly hospitalized participants with influenza A infection. The study will be conducted in 3 phases: screening phase, double-blind treatment period of 5 days (with the possibility to extend treatment period by 5 days for participants who will enter an optional double-blind extension treatment arm), and post treatment follow-up period of 23 days. Study evaluations will include efficacy, pharmacokinetic, biomarkers, safety and tolerability. The duration of participation in study for each participant is 28 days, except for participants receiving extended treatment, for whom study duration will be up to 33 days.

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Bahia Blanca, Argentina, B8001DDU
    • Hospital Interzonal General de Agudos Dr. Jose Penna
  • C.a.b.a., Argentina, 1431
    • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Cordoba, Argentina, X5016KEH
    • Hospital Privado Centro Medico de Cordoba
  • Cordoba, Argentina, 5000
    • Hospital Nuestra Senora de la Misericordia
  • Cordoba, Argentina, X5004CDT
    • Hospital Cordoba
  • Córdoba, Argentina, 5000
    • Hospital San Roque
  • Córdoba, Argentina, 5000
    • Hospital Rawson
  • General Roca, Argentina, 8332
    • Sanatorio Juan XXIII
  • La Plata, Argentina, B1900AVG
    • Instituto Medico Platense
  • La Plata Lpl Lpl, Argentina, 1900
    • Hospital Italiano de La Plata
  • Pilar, Argentina, B1629ODT
    • Hospital Universitario Austral
  • Rosario, Argentina, 2000
    • Sanatorio Britanico S.A.
• Australia
  • Bedford Park, Australia, 5042
    • Flinders Medical Centre
  • Box Hill, Australia, 3128
    • Box Hill Hospital
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Melbourne, Australia, 3050
    • Royal Melbourne Hospital
  • South Brisbane, Australia, 4101
    • Mater Hospital Brisbane
  • Townsville, Australia, 4814
    • Townsville Hospital
• Austria
  • Wien, Austria, 1090
    • AKH - Medizinische Universität Wien
  • Wien, Austria, 1100
    • SMZ Süd - Kaiser Franz Josef Spital Wien
  • Wien, Austria, 1140
    • Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital
• Belgium
  • Brussel, Belgium, 1000
    • Institut Jules Bordet
  • Bruxelles, Belgium, 1070
    • ULB Hôpital Erasme
  • Bruxelles, Belgium, 1000
    • CHU Saint-Pierre
• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Santa Casa de Misericordia de Belo Horizonte
  • Belo Horizonte, Brazil, 30150-240
    • Cardresearch - Cardiologia Assistencial
  • Brasil, Brazil, 30110-063
    • Infection Control Ltda
  • Passo Fundo, Brazil, 99010-080
    • Hospital Sao Vicente de Paulo
  • Porto Alegre, Brazil, 90610-000
    • Hospital Sao Lucas da PUCRS
  • Porto Alegre, Brazil, 90035-903
    • Hospital de Clínicas de Porto Alegre
  • Porto Alegre, Brazil, 90050-170
    • Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio
  • Sao Paulo, Brazil, 04013-060
    • Hospital da Luz
  • São José do Rio Preto, Brazil, 15090-000
    • Hospital de Medicina de São José do Rio Preto
  • São Paulo, Brazil, 01221-020
    • Irmandade Da Santa Casa de Misericordia de Sao Paulo
  • São Paulo, Brazil, 01227-200
    • Fundacao Jose Luiz Egydio Setubal
• Bulgaria
  • Ruse, Bulgaria, 7002
    • SHATPPD - Ruse Ltd.
  • Sofia, Bulgaria, 1202
    • SHATPPD - Sofia District EOOD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy - Sofia
  • Sofia, Bulgaria, 1233
    • Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD
  • Sofia, Bulgaria, 1336
    • Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
  • Veliko Tarnovo, Bulgaria, 5000
    • MHAT Dr Stefan Cherkezov
• Canada
  • Vancouver, Canada, V6Z 1Y6
    • University of British Columbia
  • Ontario
    • Sudbury, Ontario, Canada, P3E5J1
      • Health Sciences North Horizon Sante-Nord
• Chile
  • Puente Alto, Chile, 8150000
    • Hospital Dr Sotero del Rio
  • San Bernardo, Chile
    • Hospital El Pino
• China
  • Changsha, China, 410013
    • The Third Xiangya Hospital, Central South University
  • Guangzhou, China, 510515
    • Nanfang Hospital
  • Wuxi, China, 214000
    • Wuxi People's Hospital
  • Zhengzhou, China
    • Henan province people's hospital
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno
  • Kyjov, Czechia, 697 01
    • Nemocnice Kyjov, p.o.
  • Praha 8, Czechia, 180 81
    • Nemocnice Na Bulovce
• France
  • Agen cedex 9, France, 47923
    • Centre Hospitalier d'Agen
  • Amiens Cedex, France, 80054
    • CHU Amiens - Hopital Sud
  • Colombes, France, 92700
    • Hopital Louis Mourier
  • Creteil cedex, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Dijon, France, 21000
    • CHU Dijon
  • La Roche S/ Yon Cedex 9, France, 85925
    • Centre Hospitalier departemental
  • La Tronche, France, 38043
    • CHU de Grenoble - Hôpital Albert Michallon
  • Limoges, France, 87042
    • CHU de Limoges, Hopital Dupuytren
  • Lyon, France, 69003
    • Hopital Edouard Herriot - CHU Lyon
  • Marseille cedex 20, France, 13915
    • Hopital Nord - Marseille
  • NANTES Cedex 01, France, 44093
    • CHU Nantes - Hôtel Dieu
  • Nantes Cedex 1, France, 44093
    • CHU Nantes - Hôtel Dieu
  • Nice Cedex 3, France, 06202
    • CHU de Nice, Hopital de l'Archet
  • Paris, France, 75018
    • Hôpital Bichat - Claude Bernard
  • Paris, France, 75679
    • Hopital Cochin
  • Paris cedex 10, France, 75475
    • Hôpital Saint-Louis
  • Poitiers, France, 86021
    • CHU Poitiers - Hopital la Miletrie
  • Saint-Etienne Cedex 2, France, 42055
    • CHU Saint-Etienne - Hopital Nord
• Germany
  • Donaustauf, Germany, 93093
    • Klinikum Donaustauf
  • Erlangen, Germany, 91054
    • Universitaetsklinik Erlangen
  • Hessen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH
  • Koeln, Germany, 50937
    • Universitaetsklinikum Koeln
  • Luebeck, Germany, 23538
    • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Weiden, Germany, 92637
    • Klinikum Weiden
• Hungary
  • Farkasgyepü, Hungary, 8582
    • Veszprem Megyei Tudogyogyintezete
  • Torokbalint, Hungary, 2045
    • Tudogyogyintezet Torokbalint
• India
  • Ahmedabad, India, 380054
    • Zydus Hospital-Ahmedabad
  • Balaga, India, 532001
    • Rajiv Gandhi Institute of Medical Sciences
  • Bangalore, India, 560054
    • M S Ramaiah Memorial Hospital
  • Gandhinagar, India, 382424
    • Apollo Hospitals International Limited
  • Hyderabad, India, 500035
    • Aware Global Hospital
  • Jaipur, India, 302001
    • S. R. Kalla Memorial General Hospital
  • Jaipur, India, 302020
    • Eternal Heart Care Centre
  • Lucknow, India, 226006
    • Midland Healthcare & Research Center
  • Lucknow, India, 226005
    • Ajanta Research Cemtre
  • Mangalore, India, 575003
    • Vinaya Hospital and Research Center
  • Manipal, India, 576104
    • Kasturba Medical College Hospital
  • Nagpur, India, 400012
    • Suretech Hospital and Research Centre Limited
  • Nashik, India, 422007
    • Siddhi Hospital
  • New Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • New Delhi, India, 110005
    • BLK Super Specialty Hospital
  • New Delhi, India, 110070
    • Fortis Flight Lieutenant Rajan Dhall Hospital
  • Pune, India, 411023
    • Lifepoint Multispecialty Hospital
  • Pune, India, 411038
    • Sahyadri Speciality Hospital
  • Rajkot, India, 360005
    • Shree Giriraj Multispeciality Hospital
  • Surat, India, 395009
    • BAPS Pramukhswami Hospital
• Israel
  • Afula, Israel, 18101
    • Haemek Medical Center
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center
  • Beersheba, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Holon, Israel, 58100
    • Wolfson Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah University Hospita - Ein Kerem
  • Kfar-Saba, Israel, 4428164
    • Sapir Medical Center, Meir Hospital
  • Nahariya, Israel, 2210001
    • Galilee Medical Center
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center, Beilinson Campus
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Rechovot, Israel, 7610001
    • Kaplan Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Milano, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Milano, Italy, 20122
    • Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena
  • Milano, Italy, 20123
    • Ospedale San Giuseppe - Fatebenefratelli
  • Milano, Italy, 20127
    • Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro
  • Modena, Italy, 41124
    • AOU Policlinico di Modena
  • Monza, Italy, 20052
    • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
  • Novara, Italy, 28100
    • Azienda Ospedaliera Universitaria Maggiore della Carita
  • Palermo, Italy, 90127
    • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Roma, Italy, 149
    • Lazzaro Spallanzani IRCCS
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Cheongju-si, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Gangwon-do, Korea, Republic of, 220-701
    • Yonsei University Wonju Severance Christian Hospital
  • Hwaseong-si, Korea, Republic of, 18450
    • Hallym University Dongtan Sacred Heart Hospital
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Incheon, Korea, Republic of, 403-720
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Pusan, Korea, Republic of, 602-715
    • Dong-A University Hospital
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Suwon-si, Korea, Republic of, 16247
    • The Catholic University of Korea St. Vincent'S Hospital
• Latvia
  • Liepaja, Latvia, LV-3414
    • Regional Hospital of Liepaja
  • Rezekne, Latvia, LV-4600
    • Hospital of Rezekne
  • Riga, Latvia, LV1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, LV-1004
    • Children's Clinical University Hospital
  • Riga, Latvia, LV-1038
    • Riga East Clinical University Hospital
  • Riga District, Latvia, LV-2118
    • Centre of Tuberculosis and Lung Diseases
  • Valmiera, Latvia, LV-4201
    • Vidzemes Hospital
• Lithuania
  • Klaipeda, Lithuania, 92288
    • Klaipeda University Hospital
  • Siauliai, Lithuania, 76231
    • Siauliai Republican Hospital, Public Institution
  • Vilnius, Lithuania, 08117
    • Infectious Diseases Center of Vilnius University Hospital Santaros klinikos
• Malaysia
  • Alor Setar, Malaysia, 5460
    • Hospital Sultanah Bahiyah
  • Kota Kinabalu, Malaysia, 88586
    • Hospital Queen Elizabeth
  • Kuala, Malaysia, 20400
    • Hospital Sultanah Nur Zahirah
  • Kuching, Malaysia, 93586
    • Hospital Umum Sarawak
  • Miri, Malaysia, 98000
    • Hospital Miri
  • Seremban, Malaysia, 70300
    • Hospital Tuanku Jaafar
  • Sibu, Malaysia, 96000
    • Hospital Sibu
  • Sungai Buloh, Malaysia, 47000
    • Hospital Sungai Buloh
  • Taiping, Malaysia, 34000
    • Hospital Taiping
• Mexico
  • Ciudad De Mexico, Mexico, 6720
    • Hospital Infantil de Mexico Federico Gomez
  • Cuernavaca, Mexico, 62290
    • JM Research, SC
  • Guadalajara, Mexico, 44280
    • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Guadalajara, Mexico, 44340
    • Hospital Civil de Guadalajara Dr. Juan I. Menchaca
  • Mexico, Mexico, 64460
    • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
• Netherlands
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
  • Zutphen, Netherlands, 7207 AE
    • Gelre Ziekenhuizen Zutphen
  • s-Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Tauranga, New Zealand, 3143
    • Tauranga Hospital
  • Wellington, New Zealand, 6021
    • Wellington Hospital
• Peru
  • Trujillo, Peru, 13007
    • Clinica Peruano Americana S.A
• Poland
  • Debica, Poland, 39-200
    • Szpital Miejski ZOZ
  • Lancut, Poland, 37-100
    • Centrum Medyczne w Lancucie Sp.z o.o.
  • Wroclaw, Poland, 51-162
    • NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska
• Russian Federation
  • Chelyabinsk, Russian Federation, 454000
    • City Hospital #8
  • Saint-Petersburg, Russian Federation, 195067
    • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • St. Petersburg, Russian Federation, 193167
    • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • Stavropol, Russian Federation, 355000
    • LLC Reafarm
  • Yaroslavl, Russian Federation, 150007
    • Clinical Hospital #3
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 117599
    • National University Hospital
• Slovakia
  • Bratislava, Slovakia, 83340
    • DFNsP Bratislava
  • Malacky, Slovakia, 90122
    • Nemocnica Malacky, Nemocnicna A.S.
  • Michalovce, Slovakia, 07101
    • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
  • Svidnik, Slovakia, 08901
    • Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
• South Africa
  • Cape Town, South Africa, 7925
    • Clinical Research Centre University of Cape Town
  • Centurion, South Africa, 157
    • Johese Unitas
  • Durban, South Africa, 4001
    • Abdullah, IA
  • Durban, South Africa, 4001
    • Sebastian, Peter
  • Krugersdorp, South Africa, 1739
    • DJW Research
  • Pretoria, South Africa, 0084
    • Emmed Research
  • Pretoria, South Africa, 0181
    • Into Research
  • Thabazimbi, South Africa, 380
    • Limpopo Clinical Research Initiative
• Spain
  • Barcelona, Spain, 08036
    • Hosp. Clinic I Provincial de Barcelona
  • Donostia-San Sebastian, Spain, 20014
    • Hosp. Univ. Donostia
  • Elche, Spain, 3203
    • Hosp. Gral. Univ. de Elche
  • Getafe, Spain, 28905
    • Hosp. Univ. de Getafe
  • Granada, Spain, 18014
    • Hosp. Univ. Virgen de Las Nieves
  • Granada, Spain, 18012
    • Hosp. Univ. San Cecilio
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hosp. Univ. de Bellvitge
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28006
    • Hosp. Univ. de La Princesa
  • Madrid, Spain, 28660
    • Hosp. Univ. Hm Monteprincipe
  • Mataro, Spain, 08304
    • Hosp. De Mataro
  • Santiago de Compostela, Spain, 15706
    • Hosp. Clinico Univ. de Santiago
  • Terrassa, Spain, 08221
    • Hosp. Mutua Terrassa
  • Vigo, Spain, 36312
    • Hosp. Alvaro Cunqueiro
• Sweden
  • Malmö, Sweden, 205 02
    • Department for Heart Failure and Valvular Disease
  • Umeå, Sweden, 901 87
    • Norrlands Universitetssjukhus
  • Uppsala, Sweden, 75185
    • Akademiska Sjukhuset
• Taiwan
  • Kaohsiung, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital
  • Taipei, Taiwan, 116
    • Taipei Medical University-Wan Fang Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Muang, Thailand, 40002
    • Srinagarind Hospital
  • Muang, Thailand, 11000
    • Bamrasnaradura Infectious Disease Institute
  • Wattana, Thailand, 10110
    • Bumrungrad Hospital
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Aydin, Turkey, 09100
    • Adnan Menderes University
  • Diyarbakir, Turkey, 21280
    • Dicle University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli University Medical Faculty
  • Samanpazari, Altindag, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Trabzon, Turkey, 61100
    • Karadeniz Teknik University Medical Faculty
• Ukraine
  • Kharkiv, Ukraine, 61096
    • Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.
  • Kyiv, Ukraine, 1601
    • Kyiv Oleksandrivska Clinical Hospital
  • Poltava, Ukraine, 36000
    • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
  • Vinnytsia, Ukraine, 21021
    • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • Zhytomyr, Ukraine, 10002
    • Communal Institution Central City Hospital
• United Kingdom
  • Aberdeen, United Kingdom, AB25 2ZB
    • Aberdeen Royal Infirmary
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital
  • Taunton, United Kingdom, TA1 5DA
    • Musgrove Park Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
  • California
    • Fresno, California, United States, 93701
      • UCSF Fresno
    • Long Beach, California, United States, 90806
      • Miller Children's at Long Beach Medical Center
    • Stanford, California, United States, 94306-5640
      • Stanford University School of Medicine
  • Florida
    • Santa Rosa Beach, Florida, United States, 32459
      • Destin Pulmonary Critical Care, PLLS.
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201-1595
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State Univ School of Medicine
    • Detroit, Michigan, United States, 97205
      • Wayne State University
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Regents of the University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Montana
    • Butte, Montana, United States, 59701
      • Mercury Street Medical Group, PLLC
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center PRIME
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • UC Health LLC
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Lowcountry Infectious Diseases
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Tomball, Texas, United States, 77375
      • DM Clinical Research
• Vietnam
  • Hanoi, Vietnam, 100000
    • Bach Mai Hospital
  • Hanoi, Vietnam, 100000
    • National Hospital for Tropical Diseases
  • Hanoi, Vietnam
    • Thanh Nhan Hospital
  • Ho Chi Minh, Vietnam
    • Nguyen Tri Phuong Hospital
  • Ho Chi Minh, Vietnam
    • Children's Hospital 1
  • Ho Chi Minh, Vietnam
    • Children's Hospital 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Tested positive for influenza A infection after the onset of symptoms using a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
• Requires hospitalization to treat influenza infection and/or to treat complications of influenza infection (for example, radiological signs of lower respiratory tract disease, septic shock, central nervous system [CNS] involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration, myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD], decompensation of previously controlled diabetes mellitus), including participants admitted to the Intensive Care Unit (ICU)
• Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours after onset of influenza symptoms
• Being on invasive mechanical ventilation or having a peripheral capillary oxygen saturation (SpO2) less than (<)94 percent (%) on room air during screening. Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than or equal to (>=)3% from pre-influenza SpO2 during screening
• Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4

Exclusion Criteria:

• Received more than 3 doses of influenza antiviral medication (for example, oseltamivir [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first study drug intake. Received intravenous (IV) peramivir more than one 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, any history of a lung transplant)
• Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Arm 1 (pimodivir + Standard-of-Care [SOC] treatment); Participants will receive pimodivir 600 milligram (mg) orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in the protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment is determined by investigator based on local practice, may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of SOC cannot be changed (example, switching one influenza antiviral for another) during either treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in case of suspected adverse event (AE).	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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).; 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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
PLACEBO_COMPARATOR: Treatment Arm 2 (placebo + SOC treatment); 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 morning of Day 6) along with SOC treatment. Participants who meet all treatment extension criteria as defined in protocol may receive an additional 5 day course of same treatment as received at study start. The SOC treatment determined by investigator based on local practice, 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 of first study drug intake. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either treatment period/extension phase, with the exception that an influenza antiviral may be discontinued in case of a suspected AE.	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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.; Drug: 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). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hospital Recovery Scale on Day 6	The hospital recovery scale assesses a participant's clinical status. The scale provides 6 mutually exclusive conditions ordered from best to worst: 1) not hospitalized; 2) non-ICU hospitalization, not requiring supplemental oxygen; 3) non-ICU hospitalization, requiring supplemental oxygen; 4) admitted to the ICU, not requiring invasive mechanical ventilation; 5) requiring invasive mechanical ventilation; and 6) death.	Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hospital Discharge	The time to hospital discharge was defined as the time from start of study drug to hospital discharge.	Up to Day 33
Number of Participants With Adjudicated Influenza Complications	Influenza complications include pulmonary complications (such as respiratory failure, primary viral pneumonia, secondary bacterial pneumonia [including pneumonia attributable to unusual pathogens], exacerbations of chronic underlying pulmonary diseases such as chronic obstructive pulmonary disease [COPD] and asthma) and extrapulmonary complications (such as cardiovascular and cerebrovascular diseases [for example, myocardial infarction, congestive heart failure, arrhythmia, stroke], muscular disorders [for example, myositis, rhabdomyolysis], central nervous system [CNS] involvement, acute exacerbation of chronic kidney disease, decompensation of previously controlled diabetes mellitus, other infections [for example, sinusitis and otitis]).	Up to Day 33
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, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
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 33
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 33
Plasma Concentration of Pimodivir	Plasma concentration of Pimodivir was reported.	Day 1: 1 hour30minutes to 6 hours postdose, Day 3: Predose, Day 5: Predose and 1 hour30minutes to 6 hours postdose, Day 6: 12 hours postdose
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 were collected at predefined time points for clinical laboratory testing.	Up to Day 33
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.	Up to Day 33
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) was reported.	Up to Day 33

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

General Publications

• Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2018
• Primary Completion (ACTUAL): March 31, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (ACTUAL): December 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: CR108399; 2017-002156-84 (EUDRACT_NUMBER); 63623872FLZ3001 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No