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

January 31, 2025 updated by: Janssen Research & Development, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
334

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
No longer available

No longer available

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Señora 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 Hopital Erasme
      • Bruxelles, Belgium, 1000
        • CHU Saint-Pierre
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Santa Casa de Misericórdia de Belo Horizonte
      • Belo Horizonte, Brazil, 30150-240
        • Cardresearch - Cardiologia Assistencial
      • Brasil, Brazil, 30110-063
        • Infection Control Ltda
      • Passo Fundo, Brazil, 99010-080
        • Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
      • Porto Alegre, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Porto Alegre, Brazil, 90050-170
        • Irmandade Santa Casa de Misericordia de Porto Alegre
      • Porto Alegre, Brazil, 90610-000
        • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
      • Sao Jose do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • Sao Paulo, Brazil, 01221-020
        • Irmandade Santa Casa de Misericordia de Sao Paulo
      • Sao Paulo, Brazil, 01227-200
        • Fundacao Jose Luiz Egydio Setubal
      • Sao Paulo, Brazil, 04013-060
        • Hosp. Da Luz Lisboa
  • 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
    • British Columbia
      • Vancouver, British Columbia, 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, 13560
        • 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 Provincial Peoples 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 Hopital Albert Michallon
      • Limoges, France, 87042
        • CHU de Limoges Hopital Dupuytren
      • Lyon, France, 69003
        • Hopital Edouard Herriot - CHU Lyon
      • Marseille cedex 20, France, 13915
        • Hôpital 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
        • Hopital Saint Louis
      • Poitiers, France, 86021
        • CHU Poitiers - Hôpital la Milétrie
      • 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 Koelnt
      • 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 Cà 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 Carità
      • 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
      • Cheongju-si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Gangwon-do, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent'S Hospital
      • Gyeonggi-do, Korea, Republic of, 15355
        • Korea University Ansan 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
  • 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 Badan Klinicznych Piotr Napora Lekarze Spolka 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 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, 36213
        • 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, 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 Michaels 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Hospital Recovery Scale on Day 6
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Hospital Discharge
Time Frame: Up to Day 33
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
Time Frame: Up to Day 33
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
Time Frame: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
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
Time Frame: Up to Day 33
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
Time Frame: Up to Day 33
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
Time Frame: 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
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
Time Frame: Up to Day 33
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)
Time Frame: Up to Day 33
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
Time Frame: Up to Day 33
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108399
  • 2017-002156-84 (EudraCT Number)
  • 63623872FLZ3001 (Other Identifier: 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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