Study Stopped
Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.
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
3 other identifiers
interventional
334
37 countries
263
Brief Summary
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2018
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 18, 2017
CompletedStudy Start
First participant enrolled
January 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedResults Posted
Study results publicly available
April 14, 2021
CompletedFebruary 4, 2025
January 1, 2025
2.2 years
December 12, 2017
March 19, 2021
January 31, 2025
Conditions
Outcome Measures
Primary Outcomes (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.
Day 6
Secondary Outcomes (9)
Time to Hospital Discharge
Up to Day 33
Number of Participants With Adjudicated Influenza Complications
Up to Day 33
Viral Load Over Time
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
Up to Day 33
Number of Participants With Emergence of Viral Resistance to Pimodivir
Up to Day 33
- +4 more secondary outcomes
Study Arms (2)
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).
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.
Interventions
Participants will receive pimodivir 600 mg orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6). Participants 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).
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (269)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Nea Baptist Clinic
Jonesboro, Arkansas, 72401, United States
UCSF Fresno
Fresno, California, 93701, United States
Miller Children's at Long Beach Medical Center
Long Beach, California, 90806, United States
Stanford University School of Medicine
Stanford, California, 94306-5640, United States
Destin Pulmonary Critical Care, PLLS.
Santa Rosa Beach, Florida, 32459, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Augusta University
Augusta, Georgia, 30912, United States
Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
University Of Maryland Medical Center
Baltimore, Maryland, 21201-1595, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Wayne State Univ School of Medicine
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Wayne State University
Detroit, Michigan, 97205, United States
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo, Michigan, 49008, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital
Troy, Michigan, 48085, United States
Regents of the University of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University
St Louis, Missouri, 63110, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Saint Michaels Medical Center
Newark, New Jersey, 07102, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Montefiore Medical Center PRIME
The Bronx, New York, 10467, United States
UC Health LLC
Cincinnati, Ohio, 45229, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Lowcountry Infectious Diseases
Charleston, South Carolina, 29414, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
DM Clinical Research
Tomball, Texas, 77375, United States
Hospital Interzonal General de Agudos Dr. Jose Penna
Bahía Blanca, B8001DDU, Argentina
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
C.a.b.a., 1431, Argentina
Hospital Nuestra Señora de la Misericordia
Córdoba, 5000, Argentina
Hospital Rawson
Córdoba, 5000, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
Hospital Cordoba
Córdoba, X5004CDT, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Sanatorio Juan XXIII
General Roca, 8332, Argentina
Instituto Medico Platense
La Plata, B1900AVG, Argentina
Hospital Italiano de La Plata
La Plata Lpl Lpl, 1900, Argentina
Hospital Universitario Austral
Pilar, B1629ODT, Argentina
Sanatorio Britanico S.A.
Rosario, 2000, Argentina
Flinders Medical Centre
Bedford Park, 5042, Australia
Box Hill Hospital
Box Hill, 3128, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Royal Melbourne Hospital
Melbourne, 3050, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
Townsville Hospital
Townsville, 4814, Australia
AKH - Medizinische Universitat Wien
Vienna, 1090, Austria
SMZ Süd - Kaiser Franz Josef Spital Wien
Vienna, 1100, Austria
Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital
Vienna, 1140, Austria
CHU Saint-Pierre
Brussels, 1000, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
ULB Hôpital Erasme
Brussels, 1070, Belgium
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
Cardresearch - Cardiologia Assistencial
Belo Horizonte, 30150-240, Brazil
Infection Control Ltda
Brasil, 30110-063, Brazil
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, 01221-020, Brazil
Fundacao Jose Luiz Egydio Setubal
São Paulo, 01227-200, Brazil
Hosp. Da Luz Lisboa
São Paulo, 04013-060, Brazil
SHATPPD - Ruse Ltd.
Rousse, 7002, Bulgaria
SHATPPD - Sofia District EOOD
Sofia, 1202, Bulgaria
Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD
Sofia, 1233, Bulgaria
Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
Sofia, 1336, Bulgaria
Military Medical Academy - Sofia
Sofia, 1606, Bulgaria
MHAT Dr Stefan Cherkezov
Veliko Tarnovo, 5000, Bulgaria
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
Health Sciences North Horizon Sante-Nord
Greater Sudbury, Ontario, P3E5J1, Canada
Hospital Dr Sotero del Rio
Puente Alto, 8150000, Chile
Hospital El Pino
San Bernardo, 13560, Chile
The Third Xiangya Hospital, Central South University
Changsha, 410013, China
Nanfang Hospital
Guangzhou, 510515, China
Wuxi People s Hospital
Wuxi, 214000, China
Henan Provincial Peoples Hospital
Zhengzhou, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Nemocnice Kyjov, p.o.
Kyjov, 697 01, Czechia
Nemocnice Na Bulovce
Prague, 180 81, Czechia
Centre Hospitalier d'Agen
Agen, 47923, France
CHU Amiens - Hopital Sud
Amiens, 80054, France
Hopital Louis Mourier
Colombes, 92700, France
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010, France
CHU Dijon
Dijon, 21000, France
Centre Hospitalier Départemental
La Roche S/ Yon Cedex 9, 85925, France
CHU de Grenoble Hopital Albert Michallon
La Tronche, 38043, France
CHU de Limoges Hopital Dupuytren
Limoges, 87042, France
Hopital Edouard Herriot - CHU Lyon
Lyon, 69003, France
Hopital Nord Marseille
Marseille, 13915, France
CHU Nantes - Hotel Dieu
Nantes, 44093, France
CHU De Nice Hopital De l'Archet
Nice, 06202, France
Hôpital Bichat - Claude Bernard
Paris, 75018, France
Hopital Saint Louis
Paris, 75475, France
Hopital Cochin
Paris, 75679, France
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021, France
CHU Saint Etienne Hopital Nord
Saint-Etienne, 42055, France
Universitaetsklinikum Koelnt
Cologne, 50937, Germany
Klinikum Donaustauf
Donaustauf, 93093, Germany
Universitaetsklinik Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Hessen, 35392, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, 23538, Germany
Klinikum Weiden
Weiden, 92637, Germany
Veszprem Megyei Tudogyogyintezete
Farkasgyepü, 8582, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, 2045, Hungary
Zydus Hospital-Ahmedabad
Ahmedabad, 380054, India
Rajiv Gandhi Institute of Medical Sciences
Balaga, 532001, India
M S Ramaiah Memorial Hospital
Bangalore, 560054, India
Apollo Hospitals International Limited
Gandhinagar, 382424, India
Aware Global Hospital
Hyderabad, 500035, India
S. R. Kalla Memorial General Hospital
Jaipur, 302001, India
Eternal Heart Care Centre
Jaipur, 302020, India
Ajanta Research Cemtre
Lucknow, 226005, India
Midland Healthcare & Research Center
Lucknow, 226006, India
Vinaya Hospital and Research Center
Mangalore, 575003, India
Kasturba Medical College Hospital
Manipal, 576104, India
Suretech Hospital and Research Centre Limited
Nagpur, 400012, India
Siddhi Hospital
Nashik, 422007, India
BLK Super Specialty Hospital
New Delhi, 110005, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Fortis Flight Lieutenant Rajan Dhall Hospital
New Delhi, 110070, India
Lifepoint Multispecialty Hospital
Pune, 411023, India
Sahyadri Speciality Hospital
Pune, 411038, India
Shree Giriraj Multispeciality Hospital
Rajkot, 360005, India
BAPS Pramukhswami Hospital
Surat, 395009, India
Haemek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78278, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Wolfson Medical Center
Holon, 58100, Israel
Hadassah University Hospita Ein Kerem
Jerusalem, 91120, Israel
Sapir Medical Center, Meir Hospital
Kfar Saba, 4428164, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Ziv Medical Center
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena
Milan, 20122, Italy
Ospedale San Giuseppe - Fatebenefratelli
Milan, 20123, Italy
Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro
Milan, 20127, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AOU Policlinico di Modena
Modena, 41124, Italy
Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
Monza, 20052, Italy
Azienda Ospedaliera Universitaria Maggiore della Carità
Novara, 28100, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Lazzaro Spallanzani IRCCS
Roma, 149, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Regional Hospital of Liepaja
Liepāja, LV-3414, Latvia
Hospital of Rezekne
Rēzekne, LV-4600, Latvia
Children's Clinical University Hospital
Riga, LV-1004, Latvia
Riga East Clinical University Hospital
Riga, LV-1038, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Centre of Tuberculosis and Lung Diseases
Riga District, LV-2118, Latvia
Vidzemes Hospital
Valmiera, LV-4201, Latvia
Klaipeda University Hospital
Klaipėda, 92288, Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, 76231, Lithuania
Infectious Diseases Center of Vilnius University Hospital Santaros klinikos
Vilnius, 08117, Lithuania
Hospital Sultanah Bahiyah
Alor Star, 5460, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, 88586, Malaysia
Hospital Sultanah Nur Zahirah
Kuala, 20400, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Hospital Miri
Miri, 98000, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Hospital Sibu
Sibu, 96000, Malaysia
Hospital Sungai Buloh
Sungai Buloh, 47000, Malaysia
Hospital Taiping
Taiping, 34000, Malaysia
JM Research, SC
Cuernavaca, 62290, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Hospital Civil de Guadalajara Dr. Juan I. Menchaca
Guadalajara, 44340, Mexico
Hospital Infantil de Mexico Federico Gomez
Mexico City, 6720, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
México, 64460, Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Gelre Ziekenhuizen Zutphen
Zutphen, 7207 AE, Netherlands
Christchurch Hospital
Christchurch, 8011, New Zealand
Waikato Hospital
Hamilton, 3240, New Zealand
Tauranga Hospital
Tauranga, 3143, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Clinica Peruano Americana S.A
Trujillo, 13007, Peru
Szpital Miejski ZOZ
Dębica, 39-200, Poland
NZOZ Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw, 51 162, Poland
Centrum Medyczne w Lancucie Sp.z o.o.
Łańcut, 37-100, Poland
City Hospital #8
Chelyabinsk, 454000, Russia
Clinical Infectious Diseases Hospital n. a. S.P. Botkin
Saint Petersburg, 193167, Russia
Clinical Infectious Diseases Hospital n. a. S.P. Botkin
Saint Petersburg, 195067, Russia
LLC Reafarm
Stavropol, 355000, Russia
Clinical Hospital #3
Yaroslavl, 150007, Russia
National University Hospital
Singapore, 117599, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
DFNsP Bratislava
Bratislava, 83340, Slovakia
Nemocnica Malacky, Nemocnicna A.S.
Malacky, 90122, Slovakia
Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
Michalovce, 07101, Slovakia
Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
Svidník, 08901, Slovakia
Clinical Research Centre University of Cape Town
Cape Town, 7925, South Africa
Johese Unitas
Centurion, 157, South Africa
Abdullah, IA
Durban, 4001, South Africa
Sebastian, Peter
Durban, 4001, South Africa
DJW Research
Krugersdorp, 1739, South Africa
Emmed Research
Pretoria, 0084, South Africa
Into Research
Pretoria, 0181, South Africa
Limpopo Clinical Research Initiative
Thabazimbi, 380, South Africa
Chungbuk National University Hospital
Cheongju-si, 28644, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 220-701, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, 18450, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 403-720, South Korea
Dong-A University Hospital
Pusan, 602-715, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Univ. Donostia
Donostia / San Sebastian, 20014, Spain
Hosp. Gral. Univ. de Elche
Elche, 3203, Spain
Hosp. Univ. de Getafe
Getafe, 28905, Spain
Hosp. Univ. San Cecilio
Granada, 18012, Spain
Hosp. Univ. Virgen de Las Nieves
Granada, 18014, Spain
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Hm Monteprincipe
Madrid, 28660, Spain
Hosp. De Mataro
Mataró, 08304, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Mutua Terrassa
Terrassa, 08221, Spain
Hosp. Alvaro Cunqueiro
Vigo, 36213, Spain
Department for Heart Failure and Valvular Disease
Malmo, 205 02, Sweden
Norrlands Universitetssjukhus
Umeå, 901 87, Sweden
Akademiska Sjukhuset
Uppsala, 75185, Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Taipei Medical University-Wan Fang Hospital
Taipei, 116, Taiwan
Siriraj Hospital
Bangkok, 10700, Thailand
Bamrasnaradura Infectious Disease Institute
Muang, 11000, Thailand
Srinagarind Hospital
Muang, 40002, Thailand
Bumrungrad Hospital
Wattana, 10110, Thailand
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Adnan Menderes University
Aydin, 09100, Turkey (Türkiye)
Dicle University Medical Faculty
Diyarbakır, 21280, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Hacettepe University Medical Faculty
Samanpazarı, 06100, Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, 61100, Turkey (Türkiye)
Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.
Kharkiv, 61096, Ukraine
Kyiv Oleksandrivska Clinical Hospital
Kyiv, 1601, Ukraine
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava, 36000, Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21021, Ukraine
Communal Institution Central City Hospital
Zhytomyr, 10002, Ukraine
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZB, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Bach Mai Hospital
Hanoi, 100000, Vietnam
National Hospital for Tropical Diseases
Hanoi, 100000, Vietnam
Thanh Nhan Hospital
Hanoi, Vietnam
Children's Hospital 1
Ho Chi Minh City, Vietnam
Children's Hospital 2
Ho Chi Minh City, Vietnam
Nguyen Tri Phuong Hospital
Ho Chi Minh City, Vietnam
Related Publications (2)
Leopold L, Vingerhoets J, Deleu S, Nalpas C, Weber K, van Dromme I, Lowson D, Michiels B, van Duijnhoven W. Efficacy and Safety of Pimodivir Combined With Standard of Care in Hospitalized and Nonhospitalized High-Risk Adolescents and Adults With Influenza A Infection. J Infect Dis. 2025 Feb 4;231(1):e132-e143. doi: 10.1093/infdis/jiae408.
PMID: 39172627DERIVEDYoung 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.
PMID: 33248473DERIVED
MeSH Terms
Interventions
Limitations and Caveats
As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters only.
Results Point of Contact
- Title
- Senior Director Medical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 18, 2017
Study Start
January 3, 2018
Primary Completion
March 31, 2020
Study Completion
April 30, 2020
Last Updated
February 4, 2025
Results First Posted
April 14, 2021
Record last verified: 2025-01