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Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Baloxavir Marboxil
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult participants: Signed informed consent by any participant capable of giving consent, or, where the participant is not capable of giving consent, by his or her legal/authorized representative
  • Adolescent participants not able to legally consent: written informed consent for study participation is obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the participant's level of understanding and capability to provide assent
  • Participants who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization
  • Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic Test (RIDT) or reverse transcriptase-polymerase chain reaction (RT-PCR)
  • The time interval between the onset of symptoms and randomization is within 96 hours
  • A score of ≥4 based on the National Early Warning Score 2 (NEWS2)
  • Participants will require objective criteria of seriousness defined by at least one of the following criteria:
  • Requires ventilation or supplemental oxygen to support respiration
  • Has a complication related to influenza that requires hospitalization (e.g., pneumonia, central nervous system involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, asthma or chronic obstructive pulmonary disease (COPD), severe dehydration, myocarditis, pericarditis, exacerbation of ischemic heart disease)
  • For women of childbearing potential: Agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method.

Exclusion Criteria:

  • Participants who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening
  • Participants who have received baloxavir marboxil for the current influenza infection
  • Known contraindication to neuraminidase inhibitors
  • Participants hospitalized for exclusively social reasons (e.g., lack of caregivers at home)
  • Participants expected to die or be discharged within 48 hours, according to the investigator's judgement
  • Participants weighing < 40 kg
  • Participants with known severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
  • Participants with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges:
  • Alanine Transaminase (ALT) or Aspartate Transaminase (AST) level > 5 times the upper limit of normal (ULN) OR
  • ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN
  • Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment
  • Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
  • Known hypersensitivity to baloxavir marboxil or the drug product excipients

Sites / Locations

  • Torrance Memorial Medical Center
  • Denver Health Medical Center
  • Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy
  • University of Chicago; Oncology Dept
  • NorthShore University HealthSystem
  • Barnum Medical Research, Inc.
  • Detroit Receiving Hospital
  • Washington University School of Medicine
  • Mercury Street Medical Group
  • Creighton University Medical Center
  • New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine
  • Temple University Hospital ; Lung Center
  • Salem Veterans Affairs Medical Center - NAVREF; Pharmacy
  • Froedtert and The Medical College of Wisconsin
  • Instituto Medico Platense
  • Royal Brisbane & Womens Hospital; Pharmacy Department
  • Royal Children's Hospital Melbourne - PIN
  • Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery
  • Cliniques Universitaires Saint-Luc; Hematology
  • UZ Leuven
  • Santa Casa de Misericordia; de Belo Horizonte
  • Hospital Sao Vicente de Paulo
  • Centro de Estudos Clinicos do Interior Paulista
  • Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases
  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
  • MHAT Stamen Iliev AD; Pharmacy
  • University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy
  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse
  • Multiprofile Hospital for Active Treatment - Samokov EOOD
  • Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy
  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy
  • First Multiprofile Hospital for Active Treatment - Sofia EAD
  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy
  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy
  • National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
  • Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy
  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy
  • Peter Lougheed Centre
  • Foothills Medical Centre
  • Carlson Urology
  • South Health Campus
  • University of Alberta Hospital
  • Toronto East General Hospital; Main Pharmacy G Wing Basement
  • London Health Sciences Center; Pharmacy Dept.
  • Institut Universitaire de Cardiologie et de Pneumologie
  • Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases
  • Beijing Ditan Hospital Capital Medical University
  • China-Japan Friendship Hospital
  • West China Hospital, Sichuan University
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • The 1st Affiliated Hospital of Nanchang Unversity
  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
  • Zhongshan Hospital Fudan University
  • Shanghai Public Health Clinical Center
  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
  • Nemocnice Kyjov, prispevkova organizace
  • East Tallinn Central Hospital
  • Kuopion Yliopistollinen Sairaala; Silmätaudit
  • Oulun Yliopistollinen Sairaala; Teho-osasto
  • Turku University Hospital
  • Centre Hospitalier Victor Dupouy
  • CHRU Dijon Complexe Du Bocage
  • Centre Hospitalier Departemental de Vendee
  • Hôpital Universitaire Dupuytren
  • CHRU Nantes
  • CHU de Nîmes - Hôpital Carémeau
  • Hopital de La Source
  • Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie
  • Nouvel Hopital Civil - CHU Strasbourg
  • CHRU Bretonneau
  • Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz
  • Universitätsklinikum Carl Gustav Carus an der TU Dresden
  • St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin
  • Medizinische Hochschule Hannover
  • Uniklinik Koln; Klinik I fur Innere Medizin
  • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
  • Klinikum Mannheim GmbH Universitätsklinikum
  • Klinikum der Universität Regensburg
  • Universitatsklinikum Tubingen
  • Princess Margaret Hospital
  • Queen Mary Hospital
  • Prince of Wales Hospital
  • Soroka University Medical Centre
  • Edith Wolfson Medical Center
  • Galilee Medical Center
  • Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
  • Rambam Health Corporation; Oncology Institute
  • ZIV Medical Center; Department Of Internal Medicine A
  • Tel Aviv Sourasky Medical Center; Pharmacy
  • Baruch Padeh Poria Medical Center; Pharmacy
  • Fujita General Hospital
  • Shin Komonji Hospital
  • Fukuoka Shin Mizumaki Hospital
  • Fukuoka Wajiro Hospital
  • Rinku General Medical Center
  • National Hospital Organization Minami Kyoto Hospital
  • National Hospital Organization Kanazawa Medical Center
  • Japanese Red Cross Kumamoto Hospital
  • Naha City Hospital
  • National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
  • Japan Community Health care Organization Nihonmatsu hospital
  • Social Corporation Keigakukai Minamiosaka Hosupital
  • National Hospital Organaization Shibukawa Medical Center
  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
  • Saka General Hospital
  • Local incorporated administrative agency Shizuoka City Shizuoka Hospital
  • Iwase General Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Nagata Hospital; Department of pulmonary medicine
  • The Catholic University of Korea Incheon St. Mary's Hospital
  • Seoul National University Bundang Hospital
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • ChungAng University Hospital
  • Hallym University Kangnam Sacred Heart Hospital
  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia
  • Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa
  • Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
  • Hospital General de Tijuana
  • Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten
  • Canisius Wilhelmina Ziekenhuis; Department Hematology
  • Ikazia Ziekenhuis
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Universitair Medisch Centrum Utrecht
  • Wellington Hospital
  • Hospital Alberto Sabogal Sologuren
  • Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología
  • Prof. Dr. Matei Bals Institute of Infectious Diseases
  • Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases
  • Spitalul Clinic de Boli Infectioase
  • Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital
  • Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi
  • Sibiu Emergency Clinical County Hospital
  • Sf. Ioan cel Nou Emergency County Hospital
  • Clinical Center of Serbia
  • Clinical Hospital Center Zvezdara
  • Clinical Center Kragujevac
  • Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo
  • Clinical Centre of Vojvodina
  • General Hospital Dr Radivoj Simonovic Sombor
  • Institute of Lung Diseases Vojvodina
  • Tan Tock Seng Hospital
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
  • Hospital Mutua de Terrassa
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario de Torrejon
  • Hospital General Universitario de Alicante
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron - PPDS
  • Hospital Universitario Fundacion Jimenez Diaz.
  • Hospital General Universitario Reina Sofia; Servicio de Nefrologia
  • Hospital Universitario Virgen Macarena
  • Hospital de La Ribera
  • Sahlgrenska Universitetssjukhuset
  • Skånes Universitetssjukhus Malmö; Infektionskliniken
  • Hacettepe University Medical Faculty
  • Akdeniz University Medical Faculty
  • Selcuk University Medical Faculty; Internal Medicine
  • Karadeniz Technical University Faculty of Medicine
  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital
  • Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2
  • Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi
  • Ternopil City Municipal Emergency Hospital; Infectious Department
  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department
  • MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department
  • MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department
  • Municipal Institution City Clinical Infectious Diseases Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Baloxavir Marboxil

Placebo

Arm Description

Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.

Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.

Outcomes

Primary Outcome Measures

Time to Clinical Improvement
Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.

Secondary Outcome Measures

Response Rates of the 6-Point Ordinal Scale at Day 7
The ordinal scale categories are: Category 1) Discharged (or "ready for discharge") Category 2) Non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen/non-invasive ventilation Category 3) Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen/non-invasive ventilation Category 4) ICU without mechanical (invasive) ventilation (or "ready for ICU admission") Category 5) Mechanical (invasive) ventilation Category 6) Death
Time to Clinical Response
Time to Clinical Response is based on temperature ranges, oxygen saturation, respiratory status, heart rate, and hospitalization status.
Percentage of Participants on Mechanical Ventilation
Duration of Mechanical Ventilation
Percentage of Participants Requiring ICU Stay
Duration of ICU Stay
Time to Clinical Failure
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission, corresponding to ordinal scale categories 6, 5, and 4, respectively, from baseline
Time to Hospital Discharge
Percentage of Participants With Post-Treatment Influenza-Related Complications
Influenza-related complications included pneumonia, myositis or rhabdomyolysis, encephalitis or encephalopathy, myocarditis and/or pericarditis, otitis media, sinusitis, exacerbation of COPD/asthma, sepsis, acute lung injury or acute respiratory distress syndrome.
Mortality Rate at Day 7
Mortality Rate at Day 28
Time to NEWS2 of ≤ 2 Maintained for 24 Hours
A score of 0 (Range 0 - 3) indicates normal health conditions.
Time to Cessation of Viral Shedding by Virus Titer
Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of study treatment and first time when the influenza virus titer is below the limit of detection (0.75 log10 TCID50/mL)
Change From Baseline in Influenza Virus Titer at Each Timepoint
Influenza virus titer is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.
Percentage of Participants With Positive Influenza Virus Titer at Each Timepoint
Influenza virus titer is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10 TCID50/mL). A lower value indicates lower viral titer.
Area Under the Curve in Virus Titer
Time to Cessation of Viral Shedding by RT-PCR
Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of study treatment and first time when the virus RNA by RT-PCR is below the limit of detection (2.05 for flu A and 2.83 for flu B log10 virus particles/mL)
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Each Timepoint
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Percentage of Participants Positive by RT-PCR at Each Timepoint
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Percentage of Participants With AEs and SAEs Leading to Discontinuation From Treatment
Discontinuation from study treatment.
Percentage of Participants With Any Post-Treatment ALT and AST Above Baseline and >3 × ULN, >5 × ULN, >10 × ULN
ALT = alanine aminotransferase AST = aspartate transaminase
Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points
Area Under the Concentration to Time Curve From Time 0 to 72 Hours (AUC0-72) of Baloxavir
Maximum Plasma Concentration (Cmax) of Baloxavir
Apparent Half-Life (T1/2) of Baloxavir
Concentration at 24 Hours (C24) of Baloxavir

Full Information

First Posted
September 24, 2018
Last Updated
December 14, 2020
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03684044
Brief Title
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
Official Title
A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

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
This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Baloxavir Marboxil
Arm Type
Experimental
Arm Description
Participants will receive at least two doses of baloxavir marboxil on Days 1 and 4. A third dose of Baloxavir will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive at least two doses of placebo on Day 1 and 4. A third dose of placebo will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5. Study treatment will be given in combination with SOC NAI (i.e., oseltamivir, zanamivir, or peramivir) in accordance with local clinical practice.
Intervention Type
Drug
Intervention Name(s)
Baloxavir Marboxil
Intervention Description
Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo on Days 1, 4 and 7.
Primary Outcome Measure Information:
Title
Time to Clinical Improvement
Description
Time to Clinical Improvement (TTCI) is defined as Time to Hospital Discharge OR Time to NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours.
Time Frame
Up to Day 35
Secondary Outcome Measure Information:
Title
Response Rates of the 6-Point Ordinal Scale at Day 7
Description
The ordinal scale categories are: Category 1) Discharged (or "ready for discharge") Category 2) Non-ICU hospital ward (or "ready for hospital ward") not requiring supplemental oxygen/non-invasive ventilation Category 3) Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen/non-invasive ventilation Category 4) ICU without mechanical (invasive) ventilation (or "ready for ICU admission") Category 5) Mechanical (invasive) ventilation Category 6) Death
Time Frame
Day 7
Title
Time to Clinical Response
Description
Time to Clinical Response is based on temperature ranges, oxygen saturation, respiratory status, heart rate, and hospitalization status.
Time Frame
Up to Day 35
Title
Percentage of Participants on Mechanical Ventilation
Time Frame
Up to Day 35
Title
Duration of Mechanical Ventilation
Time Frame
Up to Day 35
Title
Percentage of Participants Requiring ICU Stay
Time Frame
Up to Day 35
Title
Duration of ICU Stay
Time Frame
Up to Day 35
Title
Time to Clinical Failure
Description
Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission, corresponding to ordinal scale categories 6, 5, and 4, respectively, from baseline
Time Frame
Up to Day 35
Title
Time to Hospital Discharge
Time Frame
Up to Day 35
Title
Percentage of Participants With Post-Treatment Influenza-Related Complications
Description
Influenza-related complications included pneumonia, myositis or rhabdomyolysis, encephalitis or encephalopathy, myocarditis and/or pericarditis, otitis media, sinusitis, exacerbation of COPD/asthma, sepsis, acute lung injury or acute respiratory distress syndrome.
Time Frame
Up to Day 35
Title
Mortality Rate at Day 7
Time Frame
Up to Day 7
Title
Mortality Rate at Day 28
Time Frame
Up to Day 28
Title
Time to NEWS2 of ≤ 2 Maintained for 24 Hours
Description
A score of 0 (Range 0 - 3) indicates normal health conditions.
Time Frame
Up to Day 35
Title
Time to Cessation of Viral Shedding by Virus Titer
Description
Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of study treatment and first time when the influenza virus titer is below the limit of detection (0.75 log10 TCID50/mL)
Time Frame
Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
Title
Change From Baseline in Influenza Virus Titer at Each Timepoint
Description
Influenza virus titer is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.
Time Frame
Days 2, 3, 4, 5, 7, and 10
Title
Percentage of Participants With Positive Influenza Virus Titer at Each Timepoint
Description
Influenza virus titer is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10 TCID50/mL). A lower value indicates lower viral titer.
Time Frame
Days 2, 3, 4, 5, 7, and 10
Title
Area Under the Curve in Virus Titer
Time Frame
Days 1, 2, 3, 4, 5, 7, and 10
Title
Time to Cessation of Viral Shedding by RT-PCR
Description
Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of study treatment and first time when the virus RNA by RT-PCR is below the limit of detection (2.05 for flu A and 2.83 for flu B log10 virus particles/mL)
Time Frame
Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
Title
Change From Baseline in the Amount of Virus RNA (RT-PCR) at Each Timepoint
Description
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Time Frame
Days 2, 3, 4, 5, 7, and 10
Title
Percentage of Participants Positive by RT-PCR at Each Timepoint
Description
If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)
Time Frame
Days 2, 3, 4, 5, 7, and 10
Title
Area Under the Curve in the Amount of Virus RNA (RT-PCR)
Time Frame
Days 1, 2, 3, 4, 5, 7, and 10
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Time Frame
Up to Day 35
Title
Percentage of Participants With AEs and SAEs Leading to Discontinuation From Treatment
Description
Discontinuation from study treatment.
Time Frame
Up to Day 35
Title
Percentage of Participants With Any Post-Treatment ALT and AST Above Baseline and >3 × ULN, >5 × ULN, >10 × ULN
Description
ALT = alanine aminotransferase AST = aspartate transaminase
Time Frame
Up to Day 35
Title
Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points
Time Frame
Day 1, 2, 4, 5, 7 and 8
Title
Area Under the Concentration to Time Curve From Time 0 to 72 Hours (AUC0-72) of Baloxavir
Time Frame
0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
Title
Maximum Plasma Concentration (Cmax) of Baloxavir
Time Frame
0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
Title
Apparent Half-Life (T1/2) of Baloxavir
Time Frame
0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
Title
Concentration at 24 Hours (C24) of Baloxavir
Time Frame
0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants: Signed informed consent by any participant capable of giving consent, or, where the participant is not capable of giving consent, by his or her legal/authorized representative Adolescent participants not able to legally consent: written informed consent for study participation is obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the participant's level of understanding and capability to provide assent Participants who require hospitalization for severe influenza or acquire influenza during hospitalization, the severity of which requires an extension of hospitalization Diagnosis of influenza A and/or B by a positive Rapid Influenza Diagnostic Test (RIDT) or reverse transcriptase-polymerase chain reaction (RT-PCR) The time interval between the onset of symptoms and randomization is within 96 hours A score of ≥4 based on the National Early Warning Score 2 (NEWS2) Participants will require objective criteria of seriousness defined by at least one of the following criteria: Requires ventilation or supplemental oxygen to support respiration Has a complication related to influenza that requires hospitalization (e.g., pneumonia, central nervous system involvement, myositis, rhabdomyolysis, acute exacerbation of chronic kidney disease, asthma or chronic obstructive pulmonary disease (COPD), severe dehydration, myocarditis, pericarditis, exacerbation of ischemic heart disease) For women of childbearing potential: Agreement to remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 28 days after the last dose of study treatment. Hormonal contraceptive methods must be supplemented by a barrier method. Exclusion Criteria: Participants who have received more than 48 hours of antiviral treatment for the current influenza infection prior to screening Participants who have received baloxavir marboxil for the current influenza infection Known contraindication to neuraminidase inhibitors Participants hospitalized for exclusively social reasons (e.g., lack of caregivers at home) Participants expected to die or be discharged within 48 hours, according to the investigator's judgement Participants weighing < 40 kg Participants with known severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis Participants with any of the following laboratory abnormalities detected within 24 hours prior to or during screening (according to local laboratory reference ranges: Alanine Transaminase (ALT) or Aspartate Transaminase (AST) level > 5 times the upper limit of normal (ULN) OR ALT or AST > 3 times the ULN and total bilirubin level > 2 times the ULN Pregnant or breastfeeding, or positive pregnancy test in a predose examination, or intending to become pregnant during the study or within 28 days after the last dose of study treatment Exposure to an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study Known hypersensitivity to baloxavir marboxil or the drug product excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
University of Chicago; Oncology Dept
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Barnum Medical Research, Inc.
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Temple University Hospital ; Lung Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Salem Veterans Affairs Medical Center - NAVREF; Pharmacy
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Froedtert and The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Instituto Medico Platense
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Royal Brisbane & Womens Hospital; Pharmacy Department
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Children's Hospital Melbourne - PIN
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc; Hematology
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-090
Country
Brazil
Facility Name
Centro de Estudos Clinicos do Interior Paulista
City
JAU
State/Province
SP
ZIP/Postal Code
17201-130
Country
Brazil
Facility Name
Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
City
Haskovo
ZIP/Postal Code
6305
Country
Bulgaria
Facility Name
MHAT Stamen Iliev AD; Pharmacy
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Samokov EOOD
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy
City
Smolyan
ZIP/Postal Code
4700
Country
Bulgaria
Facility Name
First Multiprofile Hospital for Active Treatment - Sofia EAD
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
City
Sofia
ZIP/Postal Code
2233
Country
Bulgaria
Facility Name
Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N-2T9
Country
Canada
Facility Name
Carlson Urology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Toronto East General Hospital; Main Pharmacy G Wing Basement
City
East York
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
London Health Sciences Center; Pharmacy Dept.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases
City
Beijing City
ZIP/Postal Code
100069
Country
China
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
10029
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Nemocnice Kyjov, prispevkova organizace
City
Kyjov
ZIP/Postal Code
697 33
Country
Czechia
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Kuopion Yliopistollinen Sairaala; Silmätaudit
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Oulun Yliopistollinen Sairaala; Teho-osasto
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
CHRU Dijon Complexe Du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Departemental de Vendee
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHRU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nîmes - Hôpital Carémeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital de La Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Nouvel Hopital Civil - CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHRU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin
City
Freiburg im Breisgau
ZIP/Postal Code
79104
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Uniklinik Koln; Klinik I fur Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Klinikum Mannheim GmbH Universitätsklinikum
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitatsklinikum Tubingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Soroka University Medical Centre
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Rambam Health Corporation; Oncology Institute
City
Rambam
ZIP/Postal Code
3525408
Country
Israel
Facility Name
ZIV Medical Center; Department Of Internal Medicine A
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Pharmacy
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Baruch Padeh Poria Medical Center; Pharmacy
City
Tiberias
ZIP/Postal Code
15208
Country
Israel
Facility Name
Fujita General Hospital
City
Dategun Kunimimachi
ZIP/Postal Code
969-1793
Country
Japan
Facility Name
Shin Komonji Hospital
City
Fukuoka
ZIP/Postal Code
800-0057
Country
Japan
Facility Name
Fukuoka Shin Mizumaki Hospital
City
Fukuoka
ZIP/Postal Code
807-0051
Country
Japan
Facility Name
Fukuoka Wajiro Hospital
City
Fukuoka
ZIP/Postal Code
811-0213
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
National Hospital Organization Minami Kyoto Hospital
City
Joyo
ZIP/Postal Code
610-0113
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
ZIP/Postal Code
861-8520
Country
Japan
Facility Name
Naha City Hospital
City
Naha
ZIP/Postal Code
902-8511
Country
Japan
Facility Name
National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
City
Naka-gun
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Japan Community Health care Organization Nihonmatsu hospital
City
Nihonmatsu
ZIP/Postal Code
964-8501
Country
Japan
Facility Name
Social Corporation Keigakukai Minamiosaka Hosupital
City
Osaka
ZIP/Postal Code
559-0012
Country
Japan
Facility Name
National Hospital Organaization Shibukawa Medical Center
City
Shibukawa
ZIP/Postal Code
377-0280
Country
Japan
Facility Name
Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
City
Shinagawa
ZIP/Postal Code
140-8522
Country
Japan
Facility Name
Saka General Hospital
City
Shiogama
ZIP/Postal Code
985-8506
Country
Japan
Facility Name
Local incorporated administrative agency Shizuoka City Shizuoka Hospital
City
Shizuoka
ZIP/Postal Code
420-8630
Country
Japan
Facility Name
Iwase General Hospital
City
Sukagawa
ZIP/Postal Code
962-8503
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo
ZIP/Postal Code
162-0052
Country
Japan
Facility Name
Nagata Hospital; Department of pulmonary medicine
City
Yanagawa-shi
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
ChungAng University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia
City
Mexico
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital General de Tijuana
City
Tijuana
ZIP/Postal Code
22320
Country
Mexico
Facility Name
Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis; Department Hematology
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6012
Country
New Zealand
Facility Name
Hospital Alberto Sabogal Sologuren
City
Callao
ZIP/Postal Code
Callao 02
Country
Peru
Facility Name
Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología
City
Cusco
ZIP/Postal Code
08006
Country
Peru
Facility Name
Prof. Dr. Matei Bals Institute of Infectious Diseases
City
Bucharest
ZIP/Postal Code
21105
Country
Romania
Facility Name
Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases
City
Bucharest
ZIP/Postal Code
30303
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase
City
Cluj Napoca
ZIP/Postal Code
400000
Country
Romania
Facility Name
Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital
City
Galati
ZIP/Postal Code
800179
Country
Romania
Facility Name
Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi
City
Iasi
ZIP/Postal Code
700116
Country
Romania
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Sf. Ioan cel Nou Emergency County Hospital
City
Suceava
ZIP/Postal Code
720224
Country
Romania
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo
City
Nis
ZIP/Postal Code
18204
Country
Serbia
Facility Name
Clinical Centre of Vojvodina
City
Nova Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
General Hospital Dr Radivoj Simonovic Sombor
City
Sombor
ZIP/Postal Code
25000
Country
Serbia
Facility Name
Institute of Lung Diseases Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario de Torrejon
City
Torrejon de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz.
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital General Universitario Reina Sofia; Servicio de Nefrologia
City
Murcia
ZIP/Postal Code
30003
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital de La Ribera
City
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skånes Universitetssjukhus Malmö; Infektionskliniken
City
Malmö
ZIP/Postal Code
SE-20502
Country
Sweden
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Selcuk University Medical Faculty; Internal Medicine
City
Konya
ZIP/Postal Code
42050
Country
Turkey
Facility Name
Karadeniz Technical University Faculty of Medicine
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
City
Chernivtsi
State/Province
Chernihiv Governorate
ZIP/Postal Code
58005
Country
Ukraine
Facility Name
Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2
City
Kyiv
State/Province
Katerynoslav Governorate
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi
City
Sumy
State/Province
Katerynoslav Governorate
ZIP/Postal Code
40021
Country
Ukraine
Facility Name
Ternopil City Municipal Emergency Hospital; Infectious Department
City
Ternopil
State/Province
KIEV Governorate
ZIP/Postal Code
46008
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department
City
Vinnytsia
State/Province
KIEV Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department
City
Vinnytsia
State/Province
KIEV Governorate
ZIP/Postal Code
21032
Country
Ukraine
Facility Name
MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department
City
Dnipro
State/Province
Podolia Governorate
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
Municipal Institution City Clinical Infectious Diseases Hospital
City
Odesa
ZIP/Postal Code
65023
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Citations:
PubMed Identifier
36171475
Citation
Stannard HL, Mifsud EJ, Wildum S, Brown SK, Koszalka P, Shishido T, Kojima S, Omoto S, Baba K, Kuhlbusch K, Hurt AC, Barr IG. Assessing the fitness of a dual-antiviral drug resistant human influenza virus in the ferret model. Commun Biol. 2022 Sep 28;5(1):1026. doi: 10.1038/s42003-022-04005-4.
Results Reference
derived
PubMed Identifier
35085510
Citation
Kumar D, Ison MG, Mira JP, Welte T, Hwan Ha J, Hui DS, Zhong N, Saito T, Katugampola L, Collinson N, Williams S, Wildum S, Ackrill A, Clinch B, Lee N. Combining baloxavir marboxil with standard-of-care neuraminidase inhibitor in patients hospitalised with severe influenza (FLAGSTONE): a randomised, parallel-group, double-blind, placebo-controlled, superiority trial. Lancet Infect Dis. 2022 May;22(5):718-730. doi: 10.1016/S1473-3099(21)00469-2. Epub 2022 Jan 24.
Results Reference
derived
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

Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza

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