Clinical trial NCT03684044: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 363
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to Clinical Improvement
timeFrame: Up to Day 35
Secondary outcomes:
measure: Response Rates of the 6-Point Ordinal Scale at Day 7
timeFrame: Day 7
measure: Time to Clinical Response
timeFrame: Up to Day 35
measure: Percentage of Participants on Mechanical Ventilation
timeFrame: Up to Day 35
measure: Duration of Mechanical Ventilation
timeFrame: Up to Day 35
measure: Percentage of Participants Requiring ICU Stay
timeFrame: Up to Day 35
measure: Duration of ICU Stay
timeFrame: Up to Day 35
measure: Time to Clinical Failure
timeFrame: Up to Day 35
measure: Time to Hospital Discharge
timeFrame: Up to Day 35
measure: Percentage of Participants With Post-Treatment Influenza-Related Complications
timeFrame: Up to Day 35
measure: Mortality Rate at Day 7
timeFrame: Up to Day 7
measure: Mortality Rate at Day 28
timeFrame: Up to Day 28
measure: Time to NEWS2 of ≤ 2 Maintained for 24 Hours
timeFrame: Up to Day 35
measure: Time to Cessation of Viral Shedding by Virus Titer
timeFrame: Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
measure: Change From Baseline in Influenza Virus Titer at Each Timepoint
timeFrame: Days 2, 3, 4, 5, 7, and 10
measure: Percentage of Participants With Positive Influenza Virus Titer at Each Timepoint
timeFrame: Days 2, 3, 4, 5, 7, and 10
measure: Area Under the Curve in Virus Titer
timeFrame: Days 1, 2, 3, 4, 5, 7, and 10
measure: Time to Cessation of Viral Shedding by RT-PCR
timeFrame: Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10
measure: Change From Baseline in the Amount of Virus RNA (RT-PCR) at Each Timepoint
timeFrame: Days 2, 3, 4, 5, 7, and 10
measure: Percentage of Participants Positive by RT-PCR at Each Timepoint
timeFrame: Days 2, 3, 4, 5, 7, and 10
measure: Area Under the Curve in the Amount of Virus RNA (RT-PCR)
timeFrame: Days 1, 2, 3, 4, 5, 7, and 10
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Day 35
measure: Percentage of Participants With AEs and SAEs Leading to Discontinuation From Treatment
timeFrame: Up to Day 35
measure: Percentage of Participants With Any Post-Treatment ALT and AST Above Baseline and >3 × ULN, >5 × ULN, >10 × ULN
timeFrame: Up to Day 35
measure: Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points
timeFrame: Day 1, 2, 4, 5, 7 and 8
measure: Area Under the Concentration to Time Curve From Time 0 to 72 Hours (AUC0-72) of Baloxavir
timeFrame: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
measure: Maximum Plasma Concentration (Cmax) of Baloxavir
timeFrame: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
measure: Apparent Half-Life (T1/2) of Baloxavir
timeFrame: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
measure: Concentration at 24 Hours (C24) of Baloxavir
timeFrame: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Decatur
country: United States
facility: Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy
state: Georgia
city: Chicago
country: United States
facility: University of Chicago; Oncology Dept
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Natchitoches
country: United States
facility: Barnum Medical Research, Inc.
state: Louisiana
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group
state: Montana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Brooklyn
country: United States
facility: New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine
state: New York
city: Philadelphia
country: United States
facility: Temple University Hospital ; Lung Center
state: Pennsylvania
city: Salem
country: United States
facility: Salem Veterans Affairs Medical Center - NAVREF; Pharmacy
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert and The Medical College of Wisconsin
state: Wisconsin
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Herston
country: Australia
facility: Royal Brisbane & Womens Hospital; Pharmacy Department
state: Queensland
city: Parkville
country: Australia
facility: Royal Children's Hospital Melbourne - PIN
state: Victoria
city: Bruxelles
country: Belgium
facility: Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc; Hematology
city: Leuven
country: Belgium
facility: UZ Leuven
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia; de Belo Horizonte
state: MG
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
state: RS
city: JAU
country: Brazil
facility: Centro de Estudos Clinicos do Interior Paulista
state: SP
city: Dimitrovgrad
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases
city: Haskovo
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD
city: Montana
country: Bulgaria
facility: MHAT Stamen Iliev AD; Pharmacy
city: Plovdiv
country: Bulgaria
facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy
city: Ruse
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse
city: Samokov
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Samokov EOOD
city: Sliven
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy
city: Smolyan
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy
city: Sofia
country: Bulgaria
facility: First Multiprofile Hospital for Active Treatment - Sofia EAD
city: Sofia
country: Bulgaria
facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy
city: Sofia
country: Bulgaria
facility: National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases
city: Veliko Tarnovo
country: Bulgaria
facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Carlson Urology
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: East York
country: Canada
facility: Toronto East General Hospital; Main Pharmacy G Wing Basement
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center; Pharmacy Dept.
state: Ontario
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie
city: Beijing City
country: China
facility: Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Nanchang
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
city: Kyjov
country: Czechia
facility: Nemocnice Kyjov, prispevkova organizace
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala; Silmätaudit
city: Oulu
country: Finland
facility: Oulun Yliopistollinen Sairaala; Teho-osasto
city: Turku
country: Finland
facility: Turku University Hospital
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Dijon
country: France
facility: CHRU Dijon Complexe Du Bocage
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental de Vendee
city: Limoges
country: France
facility: Hôpital Universitaire Dupuytren
city: Nantes
country: France
facility: CHRU Nantes
city: Nimes
country: France
facility: CHU de Nîmes - Hôpital Carémeau
city: Orleans
country: France
facility: Hopital de La Source
city: Paris
country: France
facility: Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie
city: Strasbourg
country: France
facility: Nouvel Hopital Civil - CHU Strasbourg
city: Tours
country: France
facility: CHRU Bretonneau
city: Donaustauf
country: Germany
facility: Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Freiburg im Breisgau
country: Germany
facility: St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Köln
country: Germany
facility: Uniklinik Koln; Klinik I fur Innere Medizin
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Regensburg
country: Germany
facility: Klinikum der Universität Regensburg
city: Tübingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Beer Sheva
country: Israel
facility: Soroka University Medical Centre
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit
city: Rambam
country: Israel
facility: Rambam Health Corporation; Oncology Institute
city: Safed
country: Israel
facility: ZIV Medical Center; Department Of Internal Medicine A
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center; Pharmacy
city: Tiberias
country: Israel
facility: Baruch Padeh Poria Medical Center; Pharmacy
city: Dategun Kunimimachi
country: Japan
facility: Fujita General Hospital
city: Fukuoka
country: Japan
facility: Shin Komonji Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Shin Mizumaki Hospital
city: Fukuoka
country: Japan
facility: Fukuoka Wajiro Hospital
city: Izumisano
country: Japan
facility: Rinku General Medical Center
city: Joyo
country: Japan
facility: National Hospital Organization Minami Kyoto Hospital
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Naha
country: Japan
facility: Naha City Hospital
city: Naka-gun
country: Japan
facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
city: Nihonmatsu
country: Japan
facility: Japan Community Health care Organization Nihonmatsu hospital
city: Osaka
country: Japan
facility: Social Corporation Keigakukai Minamiosaka Hosupital
city: Shibukawa
country: Japan
facility: National Hospital Organaization Shibukawa Medical Center
city: Shinagawa
country: Japan
facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai
city: Shiogama
country: Japan
facility: Saka General Hospital
city: Shizuoka
country: Japan
facility: Local incorporated administrative agency Shizuoka City Shizuoka Hospital
city: Sukagawa
country: Japan
facility: Iwase General Hospital
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Yanagawa-shi
country: Japan
facility: Nagata Hospital; Department of pulmonary medicine
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: ChungAng University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia
state: Mexico CITY (federal District)
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas
city: Tijuana
country: Mexico
facility: Hospital General de Tijuana
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis; Department Hematology
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Callao
country: Peru
facility: Hospital Alberto Sabogal Sologuren
city: Cusco
country: Peru
facility: Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología
city: Bucharest
country: Romania
facility: Prof. Dr. Matei Bals Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic de Boli Infectioase
city: Galati
country: Romania
facility: Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital
city: Iasi
country: Romania
facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Suceava
country: Romania
facility: Sf. Ioan cel Nou Emergency County Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo
city: Nova Sad
country: Serbia
facility: Clinical Centre of Vojvodina
city: Sombor
country: Serbia
facility: General Hospital Dr Radivoj Simonovic Sombor
city: Sremska Kamenica
country: Serbia
facility: Institute of Lung Diseases Vojvodina
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Torrejon de Ardoz
country: Spain
facility: Hospital Universitario de Torrejon
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz.
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofia; Servicio de Nefrologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital de La Ribera
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö; Infektionskliniken
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty; Internal Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Faculty of Medicine
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital
state: Chernihiv Governorate
city: Kyiv
country: Ukraine
facility: Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2
state: Katerynoslav Governorate
city: Sumy
country: Ukraine
facility: Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi
state: Katerynoslav Governorate
city: Ternopil
country: Ukraine
facility: Ternopil City Municipal Emergency Hospital; Infectious Department
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department
state: KIEV Governorate
city: Vinnytsia
country: Ukraine
facility: MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department
state: KIEV Governorate
city: Dnipro
country: Ukraine
facility: MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department
state: Podolia Governorate
city: Odesa
country: Ukraine
facility: Municipal Institution City Clinical Infectious Diseases Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.
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.