Clinical trial • Infectious Disease|Respiratory

BALOXAVIR MARBOXIL for Pneumonia

Clinical trial of BALOXAVIR MARBOXIL for Pneumonia. Randomised. 1590 participants.

Overview

Trial Therapeutic Area
Infectious Disease|Respiratory
Trial Disease
Pneumonia
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-10-2023
First CTIS Authorization Date
02-02-2024

Trial design

Randomised trial in France, Italy, Netherlands and others.

Randomised
Yes
Target Sample Size
1590
Trial Duration For Participant
28

Eligibility

Recruits 1590 Vulnerable population selected. Participants are adults (≥18 years). Subject information sheets and informed consent forms for adults are provided (L1_SIS and ICF adults documents exist in multiple language versions listed in the submission). No specific assent or proxy-consent handling for children is provided in the available data..

Vulnerable Population
Vulnerable population selected. Participants are adults (≥18 years). Subject information sheets and informed consent forms for adults are provided (L1_SIS and ICF adults documents exist in multiple language versions listed in the submission). No specific assent or proxy-consent handling for children is provided in the available data.

Inclusion criteria

  • {"criterion_text":"- Hospitalised patients aged ≥18 years\n- Pneumonia syndrome (clinical diagnosis, in general based on a) typical symptoms of new respiratory infection, b) objective evidence of acute lung disease [e.g. hypoxia or compatible imaging or clinical examination], and c) alternative causes considered unlikely\n- One of the following diagnoses: a) Confirmed influenza A or B infection b) Community-acquired pneumonia with planned antibiotic treatment (without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia)\n- No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if he/she were to participate in the trial\n- No reason that the trial treatment definitely should, or should not, be given in the opinion of the patient’s doctor (this only affects eligibility for the relevant comparison)"}

Exclusion criteria

  • {"criterion_text":"- No exclusion criteria"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 28 day all-cause mortality","definition_or_measurement_approach":"All-cause mortality assessed within 28 days"}
  • {"endpoint_text":"- Time to discharge alive from hospital within 28 days (patients with influenza only)","definition_or_measurement_approach":"Time from randomisation to discharge alive from hospital, measured within 28 days (applies to patients with influenza only)"}

Secondary endpoints

  • {"endpoint_text":"- Time to discharge alive from hospital within 28 days (patients without influenza)","definition_or_measurement_approach":"Time from randomisation to discharge alive from hospital, measured within 28 days (applies to patients without influenza)"}
  • {"endpoint_text":"- Progression to invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death within 28 days","definition_or_measurement_approach":"Progression to invasive mechanical ventilation (including ECMO) or death, measured within 28 days"}

Recruitment

Planned Sample Size
1590
Recruitment Window Months
30
Consent Approach
Informed consent obtained from the patient (adult participants aged ≥18). Subject information sheets and informed consent forms for adults (L1_SIS and ICF adults) are provided in multiple language versions (examples in the document list: FR, IT, NL, PT, RO, ES, SE, DE and language variants). No details on assent or proxy consent for minors are provided in the available documents.

Geography

Total Number Of Sites
67
Total Number Of Participants
1590

France

Earliest CTIS Part Ii Submission Date
16-11-2023
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
686
Number Of Sites
12
Number Of Participants
160

Sites

Site Name
University Of Strasbourg
Department Name
Infectious diseases
Contact Person Name
François DANION
Site Name
Hôpital Bichat Claude-Bernard AP-HP
Department Name
Infectious diseases and tropical diseases
Contact Person Name
Xavier Lescure
Contact Person Email
xavier.lescure@aphp.fr
Site Name
Centre Hospitalier Regional D'Angers
Department Name
Emergency Department
Contact Person Name
Delphine Douillet
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Emergency Department
Contact Person Name
Thomas Lafon
Contact Person Email
thomas.lafon@chu-limoges.fr
Site Name
Hospital Edouard Herriot
Department Name
Emergency Department
Contact Person Name
Rania Jebri
Contact Person Email
rania.jebri@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Infectious Diseases
Contact Person Name
Emmanuel Faure
Contact Person Email
emmanuel.faure2@chru-lille.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
ICU/Infectious and Tropical Diseases
Contact Person Name
Mathieu Buscot
Contact Person Email
buscot.m@chu-nice.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Emergency Department
Contact Person Name
Said Laribi
Contact Person Email
s.laribi@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Infectious diseases and tropical diseases
Contact Person Name
Guillaume Martin-Blondel
Site Name
Raymond Poincare Hospital
Department Name
Infectious Diseases
Contact Person Name
Aurelien Dinh
Contact Person Email
aurelien.dinh@aphp.fr
Site Name
Hopital Saint Antoine
Department Name
Infectious diseases
Contact Person Name
Karine Lacombe
Contact Person Email
karine.lacombe2@aphp.fr
Site Name
Pellegrin Hospital
Department Name
Infectious Diseases
Contact Person Name
Denis Malvy
Contact Person Email
denis.malvy@chu-bordeaux.fr

Italy

Earliest CTIS Part Ii Submission Date
29-01-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
611
Number Of Sites
13
Number Of Participants
160

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
Internal Medicine
Contact Person Name
Emanuele Durante Mangoni
Site Name
Azienda Sanitaria Universitaria Giuliano Isontina
Department Name
Pulmonology
Contact Person Name
Marco Confalonieri
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Gastroenterolgy and Transplantation
Contact Person Name
Marcello Tavio
Site Name
Humanitas Mirasole S.p.A.
Department Name
Pulmonology
Contact Person Name
Stefano Aliberti
Contact Person Email
stefano.alibert@hunimed.eu
Site Name
Istituto San Raffaele
Department Name
Infectious Diseases
Contact Person Name
Marco Ripa
Contact Person Email
ripa.marco@hsr.it
Site Name
Azienda Ospedaliera Universitaria Pisana
Department Name
Internal Medicine
Contact Person Name
Marco Falcone
Contact Person Email
marco.falcone@unipi.it
Site Name
ASST Fatebenefratelli Sacco
Department Name
Pulmonology
Contact Person Name
Andrea Gori
Contact Person Email
andrea.gori@unimi.it
Site Name
Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa Chiara
Department Name
Infectious Disease Unit
Contact Person Name
Massimiliano Lanzafame
Site Name
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Infectious and Tropical Diseases
Contact Person Name
Giulia Marchetti
Contact Person Email
giulia.marchetti@unimi.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Pathophysiology and Transplantation
Contact Person Name
Francesco Blasi
Contact Person Email
francesco.blasi@unimi.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Infectious Diseases
Contact Person Name
Antonio Cascio
Contact Person Email
antonio.cascio03@unipa.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Infectious Diseases
Contact Person Name
Carlo Torti
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
Infectious and Tropical Diseases Unit
Contact Person Name
Anna Maria Azzini
Contact Person Email
annamaria.azzini@univr.it

Netherlands

Earliest CTIS Part Ii Submission Date
01-09-2024
Latest Decision Or Authorization Date
04-11-2025
Processing Time Days
665
Number Of Sites
3
Number Of Participants
160

Sites

Site Name
Jeroen Bosch Ziekenhuis
Department Name
General Internal Medicine and Endocrinology
Contact Person Name
Thijs ten Doesschate
Contact Person Email
t.t.doesschate@jbz.nl
Site Name
Amsterdam UMC
Department Name
Infectious Diseases
Contact Person Name
Joost Wiersinga
Contact Person Email
w.j.wiersinga@amsterdamumc.nl
Site Name
Amphia Hospital
Department Name
Pulmonology
Contact Person Name
Remco Djamin
Contact Person Email
rdjamin@amphia.nl

Belgium

Earliest CTIS Part Ii Submission Date
31-10-2024
Latest Decision Or Authorization Date
30-09-2025
Processing Time Days
334
Number Of Sites
5
Number Of Participants
150

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Internal Medicine and Infectious Disease
Contact Person Name
Leila Belkhir
Site Name
Jessa Ziekenhuis
Department Name
Infectious Diseases
Contact Person Name
Jeroen van der Hilst
Contact Person Email
jeroen.vanderhilst@jessazh.be
Site Name
UZ Leuven
Department Name
Respiratory Medicin
Contact Person Name
Natalie Lorent
Contact Person Email
natalie.lorent@uzleuven.be
Site Name
CHU Saint-Pierre
Department Name
Infectious Diseases
Contact Person Name
Charlotte Martin
Site Name
Universitair Ziekenhuis Gent
Department Name
Dept. of Respiratory Medicine
Contact Person Name
Eva van Braeckel
Contact Person Email
Eva.VanBraeckel@uzgent.be

Estonia

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
22-10-2025
Processing Time Days
364
Number Of Sites
4
Number Of Participants
120

Sites

Site Name
Laane-Tallinna Keskhaigla AS
Department Name
Infectious Diseases
Contact Person Name
Dina Ambulte
Contact Person Email
dina.ambulte@keskhaigla.ee
Site Name
North Estonia Medical Centre Foundation
Department Name
Department of infection control
Contact Person Name
Mait Altmets
Site Name
Tartu University Hospital
Department Name
Department of infection control
Contact Person Name
Piret Mitt
Contact Person Email
Piret.Mitt@kliinikum.ee
Site Name
Sihtasutus Parnu Haigla
Department Name
Internal Medicine
Contact Person Name
Maire Link
Contact Person Email
maire.link@ph.ee

Portugal

Earliest CTIS Part Ii Submission Date
03-10-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
363
Number Of Sites
5
Number Of Participants
150

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Internal medicine
Contact Person Name
Ana Faceira
Site Name
Hospital Pedro Hispano
Department Name
Internal medicine
Contact Person Name
José Vasco Barreto
Site Name
Hospital Da Luz Arrabida S.A.
Department Name
Internal medicine
Contact Person Name
Andreia Vilas Boas
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Intensive care medicine
Contact Person Name
José Martins
Contact Person Email
2ca@ccabraga.org
Site Name
Hospital Da Luz S.A.
Department Name
Internal medicine
Contact Person Name
Bernardo Vidal Pimentel
Contact Person Email
Bernardo_pimentel@hotmail.com

Romania

Earliest CTIS Part Ii Submission Date
07-11-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
368
Number Of Sites
7
Number Of Participants
210

Sites

Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Infectious Disease
Contact Person Name
Voichita Lazureanu
Contact Person Email
lazureanu.voichita@umft.ro
Site Name
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Department Name
Boli Infectioase
Contact Person Name
Valeriu Gheorghita
Contact Person Email
valeriu.gheorghita@umfcd.ro
Site Name
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Department Name
Infectious Disease
Contact Person Name
Carmen Dorobat
Contact Person Email
carmendorobat@yahoo.com
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Department Name
Infectious Diseases
Contact Person Name
Oana Sandulescu
Contact Person Email
oana.sandulescu@umfcd.ro
Site Name
Fundatia Dr. Victor Babes
Department Name
Infectious Diseases
Contact Person Name
Simin Aysel Florescu
Contact Person Email
simin.florescu@umfcd.ro
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Clinica Boli Infectioase
Contact Person Name
Anca Meda Vasiesiu
Contact Person Email
anca-meda.vasiesiu@umfst.ro
Site Name
Spitalul Clinic De Boli Infectioase Constanta
Department Name
Infectious Diseases and Epidemiology
Contact Person Name
Irina Magdalena Dimitru

Spain

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
01-10-2025
Processing Time Days
324
Number Of Sites
9
Number Of Participants
240

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pneumology Department
Contact Person Name
Raúl Méndez Ocana
Contact Person Email
mendez_rau@gva.es
Site Name
Hospital Del Mar
Department Name
Infectious Diseases Department
Contact Person Name
Juan Pablo Horcajada Gallego
Contact Person Email
jhorcajada@parcdesalutmar.cat
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
Servicio de Medicina Interna, Unidad de infecciosas
Contact Person Name
Maria Teresa Pérez-Rodriguez
Contact Person Email
marta.llobet@iisgaliciasur.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Pulmonology Department
Contact Person Name
Ignasi Garcia Olivé
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Unidad Clinica de Engermedades Infecciosas y Microbioligia
Contact Person Name
Jose Maria Bravo-Ferrer Acosta
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Infection control unit
Contact Person Name
Joaquín López-Contreras González
Contact Person Email
jlcontreras@santpau.cat
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Infectious Diseases
Contact Person Name
José Ramón Pano-Pardo
Contact Person Email
jrpanno@unizar.es
Site Name
Hospital Universitario Central De Asturias
Department Name
Intensive care
Contact Person Name
Lorena Forcello Espina
Contact Person Email
lforcelledoespina@yahoo.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Infectious Diseases
Contact Person Name
Adrian Sanchez Montalva

Sweden

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
02-10-2025
Processing Time Days
330
Number Of Sites
9
Number Of Participants
240

Sites

Site Name
Norrlands University Hospital
Department Name
Infektionskliniken
Contact Person Name
Johan Normark
Contact Person Email
johan.normark@umu.se
Site Name
Örebro University Hospital
Department Name
Infectious Diseases
Contact Person Name
Sara Cajander
Site Name
Region Oestergoetland
Department Name
Infektionskliniken
Contact Person Name
David Ekqvist
Contact Person Email
region@regionostergotland.se
Site Name
Länsjukhuset Kalmar
Department Name
Infektionskliniken
Contact Person Name
Catharina Alexandersson
Site Name
Södersjukhuset
Department Name
Infektionskliniken/Venhälsan
Contact Person Name
Carl Johan Treutiger
Site Name
Karolinska University Hospital
Department Name
Infectious Diseases
Contact Person Name
Kristoffer Stralin
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
medicinkliniken
Contact Person Name
Daniel Holmström
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Infektionskliniken
Contact Person Name
Adam Linder
Contact Person Email
Adam.linder@skane.se
Site Name
University of Gothenburg and Sahlgrenska University Hospital (SU)
Department Name
Infectious Diseases
Contact Person Name
Johan Westin
Contact Person Email
johan.westin@gu.se

Sponsor

Primary sponsor

Full Name
University Of Oxford
Organisation Type
Educational Institution
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
Xofluza 20 mg film-coated tablets
Active Substance
BALOXAVIR MARBOXIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (EU/1/20/1500/001)
Maximum Dose
80 mg
Investigational Product Name
Dexamethasone Tablets BP 2.0mg
Active Substance
DEXAMETHASONE PH. EUR.
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (PL 39699/0056)
Maximum Dose
60 mg
Investigational Product Name
Tamiflu 75 mg hard capsules
Active Substance
OSELTAMIVIR
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (EU/1/02/222/001)
Maximum Dose
150 mg
Investigational Product Name
Dexamethasone 3.3 mg/ml solution for injection
Active Substance
DEXAMETHASONE SODIUM PHOSPHATE
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Marketing authorisation present (PL 01502 /0079)
Maximum Dose
60 mg
Investigational Product Name
Prednisolone 10mg Tablets
Active Substance
PREDNISOLONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (PL 00142/0843)
Maximum Dose
40 mg
Investigational Product Name
Hydrocortisone 100 mg, powder for solution for injection/infusion
Active Substance
HYDROCORTISONE SODIUM SUCCINATE
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Marketing authorisation present (PL 44124/0020)
Maximum Dose
160 mg

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