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AzTrials

InfluenzaPhase 3NCT03684044

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

A Phase 3 study testing Baloxavir Marboxil in people with Influenza, run by Hoffmann-La Roche at 170 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Influenza
What is being tested?
Baloxavir Marboxil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
363 participants
Where
170 sitesin 28 countries
Study dates
8 Jan 2019to 16 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

170 sites in 28 countries.

170 sites in 28 countries

Japan19 sites

  • Fujita General Hospital

    Dategun Kunimimachi, 969-1793

  • Shin Komonji Hospital

    Fukuoka, 800-0057

  • Fukuoka Shin Mizumaki Hospital

    Fukuoka, 807-0051

  • Fukuoka Wajiro Hospital

    Fukuoka, 811-0213

  • Rinku General Medical Center

    Izumisano, 598-0048

  • National Hospital Organization Minami Kyoto Hospital

    Jōyō, 610-0113

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, 920-8650

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto, 861-8520

  • Naha City Hospital

    Naha, 902-8511

  • National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

    Naka-gun, 319-1113

  • Japan Community Health care Organization Nihonmatsu hospital

    Nihonmatsu, 964-8501

  • Social Corporation Keigakukai Minamiosaka Hosupital

    Osaka, 559-0012

  • National Hospital Organaization Shibukawa Medical Center

    Shibukawa, 377-0280

  • Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

    Shinagawa City, 140-8522

  • Saka General Hospital

    Shiogama, 985-8506

  • Local incorporated administrative agency Shizuoka City Shizuoka Hospital

    Shizuoka, 420-8630

  • Iwase General Hospital

    Sukagawa, 962-8503

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-0052

  • Nagata Hospital; Department of pulmonary medicine

    Yanagawa-shi, 832-0059

Other trials in Japan

United States14 sites

  • New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine

    Brooklyn, New York, 11215

  • Mercury Street Medical Group

    Butte, Montana, 59701

  • University of Chicago; Oncology Dept

    Chicago, Illinois, 60637

  • Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy

    Decatur, Georgia, 30030

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Barnum Medical Research, Inc.

    Natchitoches, Louisiana, 71457

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Temple University Hospital ; Lung Center

    Philadelphia, Pennsylvania, 19140

  • Salem Veterans Affairs Medical Center - NAVREF; Pharmacy

    Salem, Virginia, 24153

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Torrance Memorial Medical Center

    Torrance, California, 90505

Other trials in United States

Bulgaria14 sites

  • Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases

    Dimitrovgrad, 6400

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

    Haskovo, 6305

  • MHAT Stamen Iliev AD; Pharmacy

    Montana, 3400

  • University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy

    Plovdiv, 4002

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse

    Rousse, 7002

  • Multiprofile Hospital for Active Treatment - Samokov EOOD

    Samokov, 2000

  • Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy

    Sliven, 8800

  • Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy

    Smolyan, 4700

  • First Multiprofile Hospital for Active Treatment - Sofia EAD

    Sofia, 1142

  • Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy

    Sofia, 1233

  • Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy

    Sofia, 1606

  • National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases

    Sofia, 2233

  • Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy

    Veliko Tarnovo, 5000

  • Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy

    Vratsa, 3000

Other trials in Bulgaria

Spain12 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

    Esplugues de Llobregat, Barcelona, 08950

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040

  • Hospital General Universitario Reina Sofia; Servicio de Nefrologia

    Murcia, 30003

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital Universitario de Torrejon

    Torrejón de Ardoz, Madrid, 28850

  • Hospital de La Ribera

    Valencia, 46600

Other trials in Spain

China10 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, 100015

  • Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases

    Beijing, 100069

  • China-Japan Friendship Hospital

    Beijing, 10029

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

    Shanghai, 200025

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Shanghai Public Health Clinical Center

    Shanghai, 201508

Other trials in China

France10 sites

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • CHRU Dijon Complexe Du Bocage

    Dijon, 21079

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925

  • Hôpital Universitaire Dupuytren

    Limoges, 87042

  • CHRU Nantes

    Nantes, 44093

  • CHU de Nîmes - Hôpital Carémeau

    Nîmes, 30029

  • Hopital de La Source

    Orléans, 45067

  • Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie

    Paris, 75651

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091

  • CHRU Bretonneau

    Tours, 37044

Other trials in France

Germany9 sites

  • Uniklinik Koln; Klinik I fur Innere Medizin

    Cologne, 50937

  • Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz

    Donaustauf, 93093

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin

    Freiburg im Breisgau, 79104

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

    Lübeck, 23538

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Klinikum der Universität Regensburg

    Regensburg, 93053

  • Universitatsklinikum Tubingen

    Tübingen, 72076

Other trials in Germany

Canada8 sites

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • Foothills Medical Centre

    Calgary, Alberta, T2N-2T9

  • Carlson Urology

    Calgary, Alberta, T2V 1P9

  • South Health Campus

    Calgary, Alberta, T3M 1M4

  • Toronto East General Hospital; Main Pharmacy G Wing Basement

    East York, Ontario, M4C 3E7

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1

  • London Health Sciences Center; Pharmacy Dept.

    London, Ontario, N6A 5W9

  • Institut Universitaire de Cardiologie et de Pneumologie

    Québec, G1V 4G5

Other trials in Canada

Israel8 sites

  • Soroka University Medical Centre

    Beersheba, 8410101

  • Edith Wolfson Medical Center

    Holon, 58100

  • Galilee Medical Center

    Nahariya, 22100

  • Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

    Ramat Gan, 5266202

  • Rambam Health Corporation; Oncology Institute

    Rambam, 3525408

  • ZIV Medical Center; Department Of Internal Medicine A

    Safed, 13100

  • Tel Aviv Sourasky Medical Center; Pharmacy

    Tel Aviv, 6423906

  • Baruch Padeh Poria Medical Center; Pharmacy

    Tiberias, 15208

Other trials in Israel

Ukraine8 sites

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    Chernivtsi, Chernihiv Governorate, 58005

  • MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department

    Dnipro, Podolia Governorate, 49006

  • Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2

    Kyiv, Katerynoslav Governorate, 01601

  • Municipal Institution City Clinical Infectious Diseases Hospital

    Odesa, 65023

  • Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi

    Sumy, Katerynoslav Governorate, 40021

  • Ternopil City Municipal Emergency Hospital; Infectious Department

    Ternopil, KIEV Governorate, 46008

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department

    Vinnytsia, KIEV Governorate, 21029

  • MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department

    Vinnytsia, KIEV Governorate, 21032

Other trials in Ukraine

Romania7 sites

  • Prof. Dr. Matei Bals Institute of Infectious Diseases

    Bucharest, 21105

  • Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases

    Bucharest, 30303

  • Spitalul Clinic de Boli Infectioase

    Cluj-Napoca, 400000

  • Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital

    Galati, 800179

  • Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi

    Iași, 700116

  • Sibiu Emergency Clinical County Hospital

    Sibiu, 550245

  • Sf. Ioan cel Nou Emergency County Hospital

    Suceava, 720224

Other trials in Romania

Serbia7 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Hospital Center Zvezdara

    Belgrade, 11000

  • Institute of Lung Diseases Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo

    Niš, 18204

  • Clinical Centre of Vojvodina

    Nova Sad, 21000

  • General Hospital Dr Radivoj Simonovic Sombor

    Sombor, 25000

Other trials in Serbia

South Korea7 sites

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

    Incheon, 21431

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • ChungAng University Hospital

    Seoul, 06973

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

Other trials in South Korea

Netherlands5 sites

  • Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten

    Leiden, 2333 ZA

  • Canisius Wilhelmina Ziekenhuis; Department Hematology

    Nijmegen, 6532 SZ

  • Ikazia Ziekenhuis

    Rotterdam, 3083 AN

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Mexico4 sites

  • Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa

    Guadalajara, 44280

  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia

    México, Mexico CITY (federal District), 14000

  • Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas

    Monterrey, 64460

  • Hospital General de Tijuana

    Tijuana, 22320

Other trials in Mexico

Turkey (Türkiye)4 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Akdeniz University Medical Faculty

    Antalya, 07059

  • Selcuk University Medical Faculty; Internal Medicine

    Konya, 42050

  • Karadeniz Technical University Faculty of Medicine

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Belgium3 sites

  • Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc; Hematology

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Brazil3 sites

  • Santa Casa de Misericordia; de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221

  • Centro de Estudos Clinicos do Interior Paulista

    Jaú, São Paulo, 17201-130

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090

Other trials in Brazil

Finland3 sites

  • Kuopion Yliopistollinen Sairaala; Silmätaudit

    Kuopio, 70210

  • Oulun Yliopistollinen Sairaala; Teho-osasto

    Oulu, 90220

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Hong Kong3 sites

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hospital

    Shatin, New Territories

Other trials in Hong Kong

Australia2 sites

  • Royal Brisbane & Womens Hospital; Pharmacy Department

    Herston, Queensland, 4029

  • Royal Children's Hospital Melbourne - PIN

    Parkville, Victoria, 3052

Other trials in Australia

Czechia2 sites

  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • Nemocnice Kyjov, prispevkova organizace

    Kyjov, 697 33

Other trials in Czechia

Peru2 sites

  • Hospital Alberto Sabogal Sologuren

    Callao, Callao 02

  • Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología

    Cusco, 08006

Other trials in Peru

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Skånes Universitetssjukhus Malmö; Infektionskliniken

    Malmö, SE-20502

Other trials in Sweden

Argentina1 site

  • Instituto Medico Platense

    La Plata, 1900

Other trials in Argentina

Estonia1 site

  • East Tallinn Central Hospital

    Tallinn, 10138

Other trials in Estonia

New Zealand1 site

  • Wellington Hospital

    Wellington, 6012

Other trials in New Zealand

Singapore1 site

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

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

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.

Conditions
Influenza
Being tested
Baloxavir Marboxil, Placebo
Medical subject headings
Influenza, Human

What participants receive

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

  • Baloxavir MarboxilDrug

    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.

  • PlaceboOther

    Participants will receive matching placebo on Days 1, 4 and 7.

Study groups in NCT03684044
Study groupRoleWhat they receive
Baloxavir MarboxilExperimentalParticipants 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.
Receives: Drug: Baloxavir Marboxil
PlaceboPlacebo comparatorParticipants 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.
Receives: Other: Placebo

What is being measured

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

  1. 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.

    Measured: Up to Day 35

Secondary outcomes (28)

  1. 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

    Measured: Day 7

  2. Time to Clinical Response

    Time to Clinical Response is based on temperature ranges, oxygen saturation, respiratory status, heart rate, and hospitalization status.

    Measured: Up to Day 35

  3. Percentage of Participants on Mechanical Ventilation

    Measured: Up to Day 35

  4. Duration of Mechanical Ventilation

    Measured: Up to Day 35

  5. Percentage of Participants Requiring ICU Stay

    Measured: Up to Day 35

  6. Duration of ICU Stay

    Measured: Up to Day 35

  7. 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

    Measured: Up to Day 35

  8. Time to Hospital Discharge

    Measured: Up to Day 35

  9. 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.

    Measured: Up to Day 35

  10. Mortality Rate at Day 7

    Measured: Up to Day 7

  11. Mortality Rate at Day 28

    Measured: Up to Day 28

  12. Time to NEWS2 of ≤ 2 Maintained for 24 Hours

    A score of 0 (Range 0 - 3) indicates normal health conditions.

    Measured: Up to Day 35

  13. 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)

    Measured: Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10

  14. 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.

    Measured: Days 2, 3, 4, 5, 7, and 10

  15. 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.

    Measured: Days 2, 3, 4, 5, 7, and 10

  16. Area Under the Curve in Virus Titer

    Measured: Days 1, 2, 3, 4, 5, 7, and 10

  17. 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)

    Measured: Screening (baseline) and on Days 2, 3, 4, 5, 7, and 10

  18. 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)

    Measured: Days 2, 3, 4, 5, 7, and 10

  19. 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)

    Measured: Days 2, 3, 4, 5, 7, and 10

  20. Area Under the Curve in the Amount of Virus RNA (RT-PCR)

    Measured: Days 1, 2, 3, 4, 5, 7, and 10

  21. 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.

    Measured: Up to Day 35

  22. Percentage of Participants With AEs and SAEs Leading to Discontinuation From Treatment

    Discontinuation from study treatment.

    Measured: Up to Day 35

  23. 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

    Measured: Up to Day 35

  24. Plasma Concentration of Baloxavir (Active Metabolite) at Specified Time Points

    Measured: Day 1, 2, 4, 5, 7 and 8

  25. Area Under the Concentration to Time Curve From Time 0 to 72 Hours (AUC0-72) of Baloxavir

    Measured: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8

  26. Maximum Plasma Concentration (Cmax) of Baloxavir

    Measured: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8

  27. Apparent Half-Life (T1/2) of Baloxavir

    Measured: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8

  28. Concentration at 24 Hours (C24) of Baloxavir

    Measured: 0, 0.5, 2, 4, 10, 24, 72 hours from dose on Day 1 and on Day 4, and Day 7, Day 8

Timeline

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

  1. First posted25 Sep 2018
  2. Study start8 Jan 2019
  3. Primary completion16 Mar 2020
  4. Study completion16 Mar 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03684044
Sponsor's protocol ID
CP40617
Other IDs
2018-001416-30, 2018
Status last verified
Dec 2020
First submitted
24 Sep 2018
Last updated
6 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 36171475

  • 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.

    PubMed 35085510

  • Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.

    PubMed 33248473

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baloxavir Marboxil in people with Influenza, run by Hoffmann-La Roche at 170 sites in 28 countries.

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

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in Japan, United States, Bulgaria, Spain, China and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

Time to Clinical Improvement (time frame: Up to Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03684044, which also lists 3 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.

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