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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

Primary Purpose

Influenza A

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimodivir 600 mg
Placebo
SOC Treatment
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza A

Eligibility Criteria

13 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Nea Baptist Clinic
  • UCSF Fresno
  • Miller Children's at Long Beach Medical Center
  • Stanford University School of Medicine
  • Destin Pulmonary Critical Care, PLLS.
  • Northside Hospital
  • Augusta University
  • Anne Arundel Medical Center
  • University Of Maryland Medical Center
  • Massachusetts General Hospital
  • Wayne State Univ School of Medicine
  • Henry Ford Hospital
  • Wayne State University
  • Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
  • William Beaumont Hospital
  • William Beaumont Hospital
  • Regents of the University of Minnesota
  • Washington University
  • Mercury Street Medical Group, PLLC
  • Saint Michael's Medical Center
  • Holy Name Medical Center
  • Montefiore Medical Center PRIME
  • UC Health LLC
  • Rhode Island Hospital
  • Lowcountry Infectious Diseases
  • University of Texas Southwestern Medical Center
  • DM Clinical Research
  • Hospital Interzonal General de Agudos Dr. Jose Penna
  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
  • Hospital Nuestra Señora de la Misericordia
  • Hospital Cordoba
  • Hospital Privado Centro Medico de Cordoba
  • Hospital Rawson
  • Hospital San Roque
  • Sanatorio Juan XXIII
  • Hospital Italiano de La Plata
  • Instituto Medico Platense
  • Hospital Universitario Austral
  • Sanatorio Britanico S.A.
  • Flinders Medical Centre
  • Box Hill Hospital
  • The Alfred Hospital
  • Royal Melbourne Hospital
  • Mater Hospital Brisbane
  • Townsville Hospital
  • AKH - Medizinische Universität Wien
  • SMZ Süd - Kaiser Franz Josef Spital Wien
  • Social Medizinisches Zentrum Baumgartner Höhe - Otto Wagner Spital
  • Institut Jules Bordet
  • CHU Saint-Pierre
  • ULB Hôpital Erasme
  • Santa Casa de Misericordia de Belo Horizonte
  • Cardresearch - Cardiologia Assistencial
  • Infection Control Ltda
  • Hospital Sao Vicente de Paulo
  • Hospital de Clínicas de Porto Alegre
  • Irmandade Santa Casa de Misericordia de Porto Alegre - Hospital da Crianca Santo Antonio
  • Hospital São Lucas da PUCRS
  • Hospital da Luz
  • Hospital de Medicina de São José do Rio Preto
  • Irmandade Da Santa Casa de Misericordia de Sao Paulo
  • Fundacao Jose Luiz Egydio Setubal
  • SHATPPD - Ruse Ltd.
  • SHATPPD - Sofia District EOOD
  • Fifth Multiprofile Hospital for Active Treatment - MHAT - Sofia EAD
  • Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
  • Military Medical Academy - Sofia
  • MHAT Dr Stefan Cherkezov
  • Health Sciences North Horizon Sante-Nord
  • University of British Columbia
  • Hospital Dr Sotero del Rio
  • Hospital El Pino
  • The Third Xiangya Hospital, Central South University
  • Nanfang Hospital
  • Wuxi People's Hospital
  • Henan province people's hospital
  • Fakultni nemocnice Brno
  • Nemocnice Kyjov, p.o.
  • Nemocnice Na Bulovce
  • Centre Hospitalier d'Agen
  • CHU Amiens - Hopital Sud
  • Hopital Louis Mourier
  • Centre Hospitalier Intercommunal de Créteil
  • CHU Dijon
  • Centre Hospitalier Départemental
  • CHU de Grenoble - Hôpital Albert Michallon
  • CHU de Limoges, Hopital Dupuytren
  • Hopital Edouard Herriot - CHU Lyon
  • Hôpital Nord - Marseille
  • CHU Nantes - Hotel Dieu
  • CHU Nantes - Hotel Dieu
  • CHU de Nice, Hopital de l'Archet
  • Hopital Saint-Louis
  • Hôpital Bichat - Claude Bernard
  • Hopital Cochin
  • CHU Poitiers - Hôpital la Milétrie
  • CHU Saint-Etienne - Hôpital Nord
  • Klinikum Donaustauf
  • Universitaetsklinik Erlangen
  • Universitaetsklinikum Giessen und Marburg GmbH
  • Universitaetsklinikum Koeln
  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  • Klinikum Weiden
  • Veszprem Megyei Tudogyogyintezete
  • Tudogyogyintezet Torokbalint
  • Zydus Hospital-Ahmedabad
  • Rajiv Gandhi Institute of Medical Sciences
  • M S Ramaiah Memorial Hospital
  • Apollo Hospitals International Limited
  • Aware Global Hospital
  • S. R. Kalla Memorial General Hospital
  • Eternal Heart Care Centre
  • Ajanta Research Cemtre
  • Midland Healthcare & Research Center
  • Vinaya Hospital and Research Center
  • Kasturba Medical College Hospital
  • Suretech Hospital and Research Centre Limited
  • Siddhi Hospital
  • BLK Super Specialty Hospital
  • Sir Ganga Ram Hospital
  • Fortis Flight Lieutenant Rajan Dhall Hospital
  • Lifepoint Multispecialty Hospital
  • Sahyadri Speciality Hospital
  • Shree Giriraj Multispeciality Hospital
  • BAPS Pramukhswami Hospital
  • Haemek Medical Center
  • Barzilai Medical Center
  • Soroka University Medical Center
  • Bnai Zion Medical Center
  • Rambam Health Care Campus
  • Wolfson Medical Center
  • Hadassah University Hospita - Ein Kerem
  • Sapir Medical Center, Meir Hospital
  • Galilee Medical Center
  • Rabin Medical Center, Beilinson Campus
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Ziv Medical Center
  • Tel Aviv Sourasky Medical Center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Fondazione IRCCS Ospedale Maggiore Policlinico,Mangiagalli e Regina Elena
  • Ospedale San Giuseppe - Fatebenefratelli
  • Ospedale San Raffaele- Sede Distaccata Ospedale S. Raffaele Turro
  • ASST Grande Ospedale Metropolitano Niguarda
  • AOU Policlinico di Modena
  • Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo
  • Azienda Ospedaliera Universitaria Maggiore della Carità
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Lazzaro Spallanzani IRCCS
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Korea University Ansan Hospital
  • Chungbuk National University Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Hallym University Dongtan Sacred Heart Hospital
  • Gachon University Gil Medical Center
  • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Dong-A University Hospital
  • Korea University Anam Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • Hallym University Kangnam Sacred Heart Hospital
  • Korea University Guro Hospital
  • The Catholic University of Korea St. Vincent's Hospital
  • Regional Hospital of Liepaja
  • Hospital of Rezekne
  • Centre of Tuberculosis and Lung Diseases
  • Children's Clinical University Hospital
  • Riga East Clinical University Hospital
  • Pauls Stradins Clinical University Hospital
  • Vidzemes Hospital
  • Klaipeda University Hospital
  • Siauliai Republican Hospital, Public Institution
  • Infectious Diseases Center of Vilnius University Hospital Santaros klinikos
  • Hospital Sultanah Bahiyah
  • Hospital Queen Elizabeth
  • Hospital Sultanah Nur Zahirah
  • Hospital Umum Sarawak
  • Hospital Miri
  • Hospital Tuanku Jaafar
  • Hospital Sibu
  • Hospital Sungai Buloh
  • Hospital Taiping
  • Hospital Infantil de Mexico Federico Gomez
  • JM Research, SC
  • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Hospital Civil de Guadalajara Dr. Juan I. Menchaca
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
  • Albert Schweitzer Ziekenhuis
  • Jeroen Bosch Ziekenhuis
  • UMC Utrecht
  • Gelre Ziekenhuizen Zutphen
  • Christchurch Hospital
  • Waikato Hospital
  • Tauranga Hospital
  • Wellington Hospital
  • Clinica Peruano Americana S.A
  • Szpital Miejski ZOZ
  • Centrum Medyczne w Lancucie Sp.z o.o.
  • NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska
  • City Hospital #8
  • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • LLC Reafarm
  • Clinical Hospital #3
  • National University Hospital
  • Tan Tock Seng Hospital
  • Changi General Hospital
  • DFNsP Bratislava
  • Nemocnica Malacky, Nemocnicna A.S.
  • Nemocnica s poliklinikou S. Kukuru Michalovce, a.s.
  • Nemocnica arm. generala L. Svobodu Svidnik, a.s.,
  • Clinical Research Centre University of Cape Town
  • Johese Unitas
  • Abdullah, IA
  • Sebastian, Peter
  • DJW Research
  • Emmed Research
  • Into Research
  • Limpopo Clinical Research Initiative
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Donostia
  • Hosp. Gral. Univ. de Elche
  • Hosp. Univ. de Getafe
  • Hosp. Univ. San Cecilio
  • Hosp. Univ. Virgen de Las Nieves
  • Hosp. Univ. de Bellvitge
  • Hosp. Univ. de La Princesa
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Clinico San Carlos
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. La Paz
  • Hosp. Univ. Hm Monteprincipe
  • Hosp. De Mataro
  • Hosp. Clinico Univ. de Santiago
  • Hosp. Mutua Terrassa
  • Hosp. Alvaro Cunqueiro
  • Department for Heart Failure and Valvular Disease
  • Norrlands Universitetssjukhus
  • Akademiska Sjukhuset
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Taiwan University Hospital
  • Tri-Service General Hospital
  • Taipei Medical University-Wan Fang Hospital
  • Siriraj Hospital
  • Bamrasnaradura Infectious Disease Institute
  • Srinagarind Hospital
  • Bumrungrad Hospital
  • Hacettepe University Medical Faculty
  • Adnan Menderes University
  • Dicle University Medical Faculty
  • Kocaeli University Medical Faculty
  • Hacettepe University Medical Faculty
  • Karadeniz Teknik University Medical Faculty
  • Kharkiv MA of PGE Ch of inf.dis. BO Kharkiv Reg.Cl.inf.Hosp.
  • Kyiv Oleksandrivska Clinical Hospital
  • Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
  • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
  • Communal Institution Central City Hospital
  • Aberdeen Royal Infirmary
  • Western General Hospital
  • Leeds General Infirmary
  • North Manchester General Hospital
  • Musgrove Park Hospital
  • Bach Mai Hospital
  • National Hospital for Tropical Diseases
  • Thanh Nhan Hospital
  • Children's Hospital 1
  • Children's Hospital 2
  • Nguyen Tri Phuong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Arm 1 (pimodivir + Standard-of-Care [SOC] treatment)

Treatment Arm 2 (placebo + SOC treatment)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Hospital Discharge
The time to hospital discharge was defined as the time from start of study drug to hospital discharge.
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]).
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.
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.
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).
Plasma Concentration of Pimodivir
Plasma concentration of Pimodivir was reported.
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.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.
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.

Full Information

First Posted
December 12, 2017
Last Updated
March 19, 2021
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03376321
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
334 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1 (pimodivir + Standard-of-Care [SOC] treatment)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment Arm 2 (placebo + SOC treatment)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pimodivir 600 mg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
SOC Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Hospital Recovery Scale on Day 6
Description
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.
Time Frame
Day 6
Secondary Outcome Measure Information:
Title
Time to Hospital Discharge
Description
The time to hospital discharge was defined as the time from start of study drug to hospital discharge.
Time Frame
Up to Day 33
Title
Number of Participants With Adjudicated Influenza Complications
Description
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]).
Time Frame
Up to Day 33
Title
Viral Load Over Time
Description
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.
Time Frame
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14 and 19
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
Up to Day 33
Title
Number of Participants With Emergence of Viral Resistance to Pimodivir
Description
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).
Time Frame
Up to Day 33
Title
Plasma Concentration of Pimodivir
Description
Plasma concentration of Pimodivir was reported.
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
Title
Number of Participants With Clinically Significant Changes in Laboratory Tests
Description
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.
Time Frame
Up to Day 33
Title
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Description
Number of participants with clinically significant changes in Electrocardiogram (ECG) was reported.
Time Frame
Up to Day 33
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
Number of participants with clinically significant changes in vital signs (temperature, pulse rate, respiratory rate and blood pressure) was reported.
Time Frame
Up to Day 33

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33248473
Citation
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.
Results Reference
derived

Learn more about this trial

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

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