AzTrials
AzTrials

Influenza APhase 3NCT03376321

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 study testing Pimodivir 600 mg and SOC Treatment in people with Influenza A, run by Janssen Research & Development, LLC at 269 sites in 38 countries.

Terminated

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

Official record
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Trial summary

The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment. Read more about this study

Who is it for?
Ages 13 to 85 years
Conditions the study is for
Influenza A
What is being tested?
Pimodivir 600 mg and SOC Treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
269 sitesin 38 countries
Study dates
3 Jan 2018to 30 Apr 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

269 sites in 38 countries.

269 sites in 38 countries

United States28 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Augusta University

    Augusta, Georgia, 30912

  • University Of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701

  • Lowcountry Infectious Diseases

    Charleston, South Carolina, 29414

  • UC Health LLC

    Cincinnati, Ohio, 45229

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Wayne State Univ School of Medicine

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Wayne State University

    Detroit, Michigan, 97205

  • UCSF Fresno

    Fresno, California, 93701

  • Nea Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

    Kalamazoo, Michigan, 49008

  • Miller Children's at Long Beach Medical Center

    Long Beach, California, 90806

  • Regents of the University of Minnesota

    Minneapolis, Minnesota, 55455

  • Saint Michaels Medical Center

    Newark, New Jersey, 07102

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Destin Pulmonary Critical Care, PLLS.

    Santa Rosa Beach, Florida, 32459

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94306-5640

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Montefiore Medical Center PRIME

    The Bronx, New York, 10467

  • DM Clinical Research

    Tomball, Texas, 77375

  • William Beaumont Hospital

    Troy, Michigan, 48085

Other trials in United States

India20 sites

  • Zydus Hospital-Ahmedabad

    Ahmedabad, 380054

  • Rajiv Gandhi Institute of Medical Sciences

    Balaga, 532001

  • M S Ramaiah Memorial Hospital

    Bangalore, 560054

  • Apollo Hospitals International Limited

    Gandhinagar, 382424

  • Aware Global Hospital

    Hyderabad, 500035

  • S. R. Kalla Memorial General Hospital

    Jaipur, 302001

  • Eternal Heart Care Centre

    Jaipur, 302020

  • Ajanta Research Cemtre

    Lucknow, 226005

  • Midland Healthcare & Research Center

    Lucknow, 226006

  • Vinaya Hospital and Research Center

    Mangalore, 575003

  • Kasturba Medical College Hospital

    Manipal, 576104

  • Suretech Hospital and Research Centre Limited

    Nagpur, 400012

  • Siddhi Hospital

    Nashik, 422007

  • BLK Super Specialty Hospital

    New Delhi, 110005

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Fortis Flight Lieutenant Rajan Dhall Hospital

    New Delhi, 110070

  • Lifepoint Multispecialty Hospital

    Pune, 411023

  • Sahyadri Speciality Hospital

    Pune, 411038

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • BAPS Pramukhswami Hospital

    Surat, 395009

Other trials in India

France17 sites

  • Centre Hospitalier d'Agen

    Agen, 47923

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • Hopital Louis Mourier

    Colombes, 92700

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • CHU Dijon

    Dijon, 21000

  • Centre Hospitalier Départemental

    La Roche S/ Yon Cedex 9, 85925

  • CHU de Grenoble Hopital Albert Michallon

    La Tronche, 38043

  • CHU de Limoges Hopital Dupuytren

    Limoges, 87042

  • Hopital Edouard Herriot - CHU Lyon

    Lyon, 69003

  • Hopital Nord Marseille

    Marseille, 13915

  • CHU Nantes - Hotel Dieu

    Nantes, 44093

  • CHU De Nice Hopital De l'Archet

    Nice, 06202

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint Louis

    Paris, 75475

  • Hopital Cochin

    Paris, 75679

  • CHU Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • CHU Saint Etienne Hopital Nord

    Saint-Etienne, 42055

Other trials in France

Spain17 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20014

  • Hosp. Gral. Univ. de Elche

    Elche, 3203

  • Hosp. Univ. de Getafe

    Getafe, 28905

  • Hosp. Univ. San Cecilio

    Granada, 18012

  • Hosp. Univ. Virgen de Las Nieves

    Granada, 18014

  • Hosp. Univ. de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hosp. Univ. de La Princesa

    Madrid, 28006

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Hm Monteprincipe

    Madrid, 28660

  • Hosp. De Mataro

    Mataró, 08304

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Mutua Terrassa

    Terrassa, 08221

  • Hosp. Alvaro Cunqueiro

    Vigo, 36213

Other trials in Spain

Israel14 sites

  • Haemek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Wolfson Medical Center

    Holon, 58100

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 91120

  • Sapir Medical Center, Meir Hospital

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 2210001

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 7610001

  • Ziv Medical Center

    Safed, 13100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

South Korea13 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, 220-701

  • Korea University Ansan Hospital

    Gyeonggi-do, 15355

  • The Catholic university of Korea, St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

  • Gachon University Gil Medical Center

    Incheon, 21565

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

    Incheon, 403-720

  • Dong-A University Hospital

    Pusan, 602-715

  • Korea University Anam Hospital

    Seoul, 02841

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

Argentina12 sites

  • Hospital Interzonal General de Agudos Dr. Jose Penna

    Bahía Blanca, B8001DDU

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

    C.a.b.a., 1431

  • Hospital Nuestra Señora de la Misericordia

    Córdoba, 5000

  • Hospital Rawson

    Córdoba, 5000

  • Hospital San Roque

    Córdoba, 5000

  • Hospital Cordoba

    Córdoba, X5004CDT

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Sanatorio Juan XXIII

    General Roca, 8332

  • Instituto Medico Platense

    La Plata, B1900AVG

  • Hospital Italiano de La Plata

    La Plata Lpl Lpl, 1900

  • Hospital Universitario Austral

    Pilar, B1629ODT

  • Sanatorio Britanico S.A.

    Rosario, 2000

Other trials in Argentina

Brazil11 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, 30150-221

  • Cardresearch - Cardiologia Assistencial

    Belo Horizonte, 30150-240

  • Infection Control Ltda

    Brasil, 30110-063

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

    Passo Fundo, 99010-080

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90050-170

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

    Porto Alegre, 90610-000

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000

  • Irmandade Santa Casa de Misericordia de Sao Paulo

    São Paulo, 01221-020

  • Fundacao Jose Luiz Egydio Setubal

    São Paulo, 01227-200

  • Hosp. Da Luz Lisboa

    São Paulo, 04013-060

Other trials in Brazil

Italy11 sites

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena

    Milan, 20122

  • Ospedale San Giuseppe - Fatebenefratelli

    Milan, 20123

  • Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro

    Milan, 20127

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AOU Policlinico di Modena

    Modena, 41124

  • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

    Monza, 20052

  • Azienda Ospedaliera Universitaria Maggiore della Carità

    Novara, 28100

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Lazzaro Spallanzani IRCCS

    Roma, 149

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

Malaysia9 sites

  • Hospital Sultanah Bahiyah

    Alor Star, 5460

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

  • Hospital Sultanah Nur Zahirah

    Kuala, 20400

  • Hospital Umum Sarawak

    Kuching, 93586

  • Hospital Miri

    Miri, 98000

  • Hospital Tuanku Jaafar

    Seremban, 70300

  • Hospital Sibu

    Sibu, 96000

  • Hospital Sungai Buloh

    Sungai Buloh, 47000

  • Hospital Taiping

    Taiping, 34000

Other trials in Malaysia

South Africa8 sites

  • Clinical Research Centre University of Cape Town

    Cape Town, 7925

  • Johese Unitas

    Centurion, 157

  • Abdullah, IA

    Durban, 4001

  • Sebastian, Peter

    Durban, 4001

  • DJW Research

    Krugersdorp, 1739

  • Emmed Research

    Pretoria, 0084

  • Into Research

    Pretoria, 0181

  • Limpopo Clinical Research Initiative

    Thabazimbi, 380

Other trials in South Africa

Latvia7 sites

  • Regional Hospital of Liepaja

    Liepāja, LV-3414

  • Hospital of Rezekne

    Rēzekne, LV-4600

  • Children's Clinical University Hospital

    Riga, LV-1004

  • Riga East Clinical University Hospital

    Riga, LV-1038

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

  • Centre of Tuberculosis and Lung Diseases

    Riga District, LV-2118

  • Vidzemes Hospital

    Valmiera, LV-4201

Other trials in Latvia

Australia6 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Box Hill Hospital

    Box Hill, 3128

  • The Alfred Hospital

    Melbourne, 3004

  • Royal Melbourne Hospital

    Melbourne, 3050

  • Mater Hospital Brisbane

    South Brisbane, 4101

  • Townsville Hospital

    Townsville, 4814

Other trials in Australia

Bulgaria6 sites

  • SHATPPD - Ruse Ltd.

    Rousse, 7002

  • SHATPPD - Sofia District EOOD

    Sofia, 1202

  • Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD

    Sofia, 1233

  • Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD

    Sofia, 1336

  • Military Medical Academy - Sofia

    Sofia, 1606

  • MHAT Dr Stefan Cherkezov

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Germany6 sites

  • Universitaetsklinikum Koelnt

    Cologne, 50937

  • Klinikum Donaustauf

    Donaustauf, 93093

  • Universitaetsklinik Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Giessen und Marburg GmbH

    Hessen, 35392

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

    Lübeck, 23538

  • Klinikum Weiden

    Weiden, 92637

Other trials in Germany

Turkey (Türkiye)6 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Adnan Menderes University

    Aydin, 09100

  • Dicle University Medical Faculty

    Diyarbakır, 21280

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Hacettepe University Medical Faculty

    Samanpazarı, 06100

  • Karadeniz Teknik University Medical Faculty

    Trabzon, 61100

Other trials in Turkey (Türkiye)

Vietnam6 sites

  • Bach Mai Hospital

    Hanoi, 100000

  • National Hospital for Tropical Diseases

    Hanoi, 100000

  • Thanh Nhan Hospital

    Hanoi

  • Children's Hospital 1

    Ho Chi Minh City

  • Children's Hospital 2

    Ho Chi Minh City

  • Nguyen Tri Phuong Hospital

    Ho Chi Minh City

Other trials in Vietnam

Mexico5 sites

  • JM Research, SC

    Cuernavaca, 62290

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • Hospital Civil de Guadalajara Dr. Juan I. Menchaca

    Guadalajara, 44340

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    México, 64460

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 6720

Other trials in Mexico

Russia5 sites

  • City Hospital #8

    Chelyabinsk, 454000

  • Clinical Infectious Diseases Hospital n. a. S.P. Botkin

    Saint Petersburg, 193167

  • Clinical Infectious Diseases Hospital n. a. S.P. Botkin

    Saint Petersburg, 195067

  • LLC Reafarm

    Stavropol, 355000

  • Clinical Hospital #3

    Yaroslavl, 150007

Other trials in Russia

Ukraine5 sites

  • Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.

    Kharkiv, 61096

  • Kyiv Oleksandrivska Clinical Hospital

    Kyiv, 1601

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

    Poltava, 36000

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

    Vinnytsia, 21021

  • Communal Institution Central City Hospital

    Zhytomyr, 10002

Other trials in Ukraine

United Kingdom5 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZB

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • North Manchester General Hospital

    Manchester, M8 5RB

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

China4 sites

  • The Third Xiangya Hospital, Central South University

    Changsha, 410013

  • Nanfang Hospital

    Guangzhou, 510515

  • Wuxi People s Hospital

    Wuxi, 214000

  • Henan Provincial Peoples Hospital

    Zhengzhou

Other trials in China

Netherlands4 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • UMC Utrecht

    Utrecht, 3584 CX

  • Gelre Ziekenhuizen Zutphen

    Zutphen, 7207 AE

Other trials in Netherlands

New Zealand4 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Waikato Hospital

    Hamilton, 3240

  • Tauranga Hospital

    Tauranga, 3143

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

Slovakia4 sites

  • DFNsP Bratislava

    Bratislava, 83340

  • Nemocnica Malacky, Nemocnicna A.S.

    Malacky, 90122

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

    Michalovce, 07101

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

    Svidník, 08901

Other trials in Slovakia

Taiwan4 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 80756

  • National Taiwan University Hospital

    Taipei, 10002

  • Tri-Service General Hospital

    Taipei, 114

  • Taipei Medical University-Wan Fang Hospital

    Taipei, 116

Other trials in Taiwan

Thailand4 sites

  • Siriraj Hospital

    Bangkok, 10700

  • Bamrasnaradura Infectious Disease Institute

    Muang, 11000

  • Srinagarind Hospital

    Muang, 40002

  • Bumrungrad Hospital

    Wattana, 10110

Other trials in Thailand

Austria3 sites

  • AKH - Medizinische Universitat Wien

    Vienna, 1090

  • SMZ Süd - Kaiser Franz Josef Spital Wien

    Vienna, 1100

  • Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital

    Vienna, 1140

Other trials in Austria

Belgium3 sites

  • CHU Saint-Pierre

    Brussels, 1000

  • Institut Jules Bordet

    Brussels, 1000

  • ULB Hôpital Erasme

    Brussels, 1070

Other trials in Belgium

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Nemocnice Kyjov, p.o.

    Kyjov, 697 01

  • Nemocnice Na Bulovce

    Prague, 180 81

Other trials in Czechia

Lithuania3 sites

  • Klaipeda University Hospital

    Klaipėda, 92288

  • Siauliai Republican Hospital, Public Institution

    Šiauliai, 76231

  • Infectious Diseases Center of Vilnius University Hospital Santaros klinikos

    Vilnius, 08117

Other trials in Lithuania

Poland3 sites

  • Szpital Miejski ZOZ

    Dębica, 39-200

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

    Łańcut, 37-100

  • NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

    Wroclaw, 51 162

Other trials in Poland

Singapore3 sites

  • National University Hospital

    Singapore, 117599

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Sweden3 sites

  • Department for Heart Failure and Valvular Disease

    Malmö, 205 02

  • Norrlands Universitetssjukhus

    Umeå, 901 87

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Canada2 sites

  • Health Sciences North Horizon Sante-Nord

    Greater Sudbury, Ontario, P3E5J1

  • University of British Columbia

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Chile2 sites

  • Hospital Dr Sotero del Rio

    Puente Alto, 8150000

  • Hospital El Pino

    San Bernardo, 13560

Other trials in Chile

Hungary2 sites

  • Veszprem Megyei Tudogyogyintezete

    Farkasgyepü, 8582

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Peru1 site

  • Clinica Peruano Americana S.A

    Trujillo, 13007

Other trials in Peru

About this study

Official title: 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.

Read the detailed description

This double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with SOC treatment versus placebo in combination with SOC treatment in adolescent, 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.

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

What participants receive

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

  • Pimodivir 600 mgDrug

    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).

  • PlaceboDrug

    Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6). 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).

  • SOC TreatmentOther

    Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be 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.

Study groups in NCT03376321
Study groupRoleWhat they receive
Treatment Arm 1 (pimodivir + Standard-of-Care [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 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).
Receives: Drug: Pimodivir 600 mg; Other: SOC Treatment
Treatment Arm 2 (placebo + SOC treatment)Placebo comparatorParticipants will receive placebo matching to pimodivir orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until 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.
Receives: Drug: Placebo; Other: SOC Treatment

What is being measured

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

  1. 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.

    Measured: Day 6

Secondary outcomes (9)

  1. Time to Hospital Discharge

    The time to hospital discharge was defined as the time from start of study drug to hospital discharge.

    Measured: Up to Day 33

  2. 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]).

    Measured: Up to Day 33

  3. Viral Load Over Time

    Viral load over time was measured by quantitative real time polymerase chain reaction (qRT-PCR) and viral culture in the mid-turbinate (MT) nasal swabs and endotracheal samples.

    Measured: Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19

  4. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

    Measured: Up to Day 33

  5. Number of Participants With Emergence of Viral Resistance to Pimodivir

    Emergence of viral resistance to Pimodivir was detected by genotyping and/or phenotyping. Nasal MT swabs and endotracheal samples were used for sequence analysis of the polymerase basic protein (PB)2 region of the influenza polymerase gene, and of neuraminidase (NA) genes for participants using an NA inhibitor (NAI) as part of their Standard of Care (SOC).

    Measured: Up to Day 33

  6. Plasma Concentration of Pimodivir

    Plasma concentration of Pimodivir was reported.

    Measured: 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

  7. 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.

    Measured: Up to Day 33

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

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

    Measured: Up to Day 33

  9. 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.

    Measured: Up to Day 33

Timeline

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

  1. First posted18 Dec 2017
  2. Study start3 Jan 2018
  3. Primary completion31 Mar 2020
  4. Study completion30 Apr 2020

Why it stopped: Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03376321
Sponsor's protocol ID
CR108399
Other IDs
2017-002156-84, 63623872FLZ3001, 2017
Status last verified
Jan 2025
First submitted
12 Dec 2017
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Publications

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

    PubMed 39172627

  • 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.

    PubMed 33248473

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimodivir 600 mg and SOC Treatment in people with Influenza A, run by Janssen Research & Development, LLC at 269 sites in 38 countries.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

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

Where is the study taking place?

The record lists 269 sites in United States, India, France, Spain, Israel and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Number of Participants With Hospital Recovery Scale on Day 6 (time frame: Day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03376321, which also lists 2 linked publications.

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

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

How often is this information updated?

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

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