Clinical trial • Phase III • Respiratory

TOZORAKIMAB for Severe viral lung infections

Phase III trial of TOZORAKIMAB for Severe viral lung infections.

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Severe viral lung infections
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-01-2024
First CTIS Authorization Date
16-02-2024

Trial design

Randomised, arm 1: tozorakimab — single dose (no dose amount specified in provided data) as add-on to standard of care; arm 2: matching placebo — single dose (matching placebo). randomised 1:1.-controlled Phase III trial in Slovakia, Germany, Hungary and others.

Randomised
Yes
Comparator
Arm 1: Tozorakimab — single dose (no dose amount specified in provided data) as add-on to standard of care; Arm 2: Matching placebo — single dose (matching placebo). Randomised 1:1.
Target Sample Size
2870
Trial Duration For Participant
60

Eligibility

Recruits 2870 Vulnerable population selected. Only adults (≥18 years) may provide informed consent (principal inclusion criterion). Site-specific informed consent documents and addenda are provided (including materials labelled for pregnant partners and specific addenda for future research and personal data). No minors/assent procedures are described in the provided criteria..

Vulnerable Population
Vulnerable population selected. Only adults (≥18 years) may provide informed consent (principal inclusion criterion). Site-specific informed consent documents and addenda are provided (including materials labelled for pregnant partners and specific addenda for future research and personal data). No minors/assent procedures are described in the provided criteria.

Inclusion criteria

  • {"criterion_text":"- 1. Adult participants ≥ 18 years old at the time of signing the informed consent form."}
  • {"criterion_text":"- 2. Patients hospitalised with viral lung infection."}
  • {"criterion_text":"- 3. Hypoxaemia requiring treatment with supplemental O2. Hypoxaemia is defined as: SpO2 ≤ 90% OR SpO2 ≤ 92% AND one or both of the following: Radiographic infiltrates by CXR/CT compatible with viral lung infection per investigator judgement. Use of accessory muscles of respiration or RR > 22."}
  • {"criterion_text":"- 4. Patient remains hypoxaemic at randomisation requiring treatment with supplemental oxygen."}

Exclusion criteria

  • {"criterion_text":"- 1. Known fungal or parasitic lung infection, aspiration lung infection, lung abscess, or evidence of septic shock. Bacterial co-infection is allowed, unless, in the opinion of the investigator, bacterial infection defines the severity of the participant’s condition."}
  • {"criterion_text":"- 2. Hypoxaemia caused primarily by extrapulmonary insult or by lung injury of non-infective aetiology."}
  • {"criterion_text":"- 3. Ongoing IMV/ECMO at randomisation."}
  • {"criterion_text":"- 4. The following malignancies: - Solid tumours with metastases (Stage IV). - Lymphoma/leukaemia not in complete remission. - Malignancies treated with chemotherapy and/or immunomodulatory drugs within the past 2 months."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of participants who die or progress to IMV/ECMO by Day 28","definition_or_measurement_approach":"Measured as the proportion of randomised participants who have died or progressed to invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) by Day 28."}

Secondary endpoints

  • {"endpoint_text":"- 1. Proportion of participants who die by Day 60","definition_or_measurement_approach":"Measured as the proportion of participants who have died by Day 60."}
  • {"endpoint_text":"- 2. Number of days alive and outside of ICU over 28 day period","definition_or_measurement_approach":"Count of days alive and not in ICU during the 28-day assessment period."}
  • {"endpoint_text":"- 3. Number of days alive and free of supplemental oxygen over 28 day period","definition_or_measurement_approach":"Count of days alive without supplemental oxygen during the 28-day assessment period."}
  • {"endpoint_text":"- 4. Time to death or progression to IMV/ECMO","definition_or_measurement_approach":"Time-to-event endpoint measuring time from randomisation to death or progression to IMV/ECMO."}
  • {"endpoint_text":"- 5. Proportion of participants who die or progress to IMV/ECMO by Day 60","definition_or_measurement_approach":"Measured as the proportion of participants who have died or progressed to IMV/ECMO by Day 60."}
  • {"endpoint_text":"- 6. Time to death (all cause)","definition_or_measurement_approach":"Time from randomisation to death from any cause."}
  • {"endpoint_text":"- 7. Proportion of participants who die by Day 28","definition_or_measurement_approach":"Measured as the proportion of participants who have died by Day 28."}
  • {"endpoint_text":"- 8. Number of days alive and free of IMV/ECMO over 28 day and 60 day period","definition_or_measurement_approach":"Count of days alive without IMV/ECMO during 28-day and 60-day assessment windows."}
  • {"endpoint_text":"- 9. Number of days alive and ventilator free over 28 day and 60 day period","definition_or_measurement_approach":"Count of days alive and not on ventilator support during 28-day and 60-day periods."}
  • {"endpoint_text":"- 10. Proportion of participants with ICU admission or death by Day 28 and Day 60","definition_or_measurement_approach":"Proportion of participants admitted to ICU or dead at Day 28 and at Day 60."}
  • {"endpoint_text":"- 11. Proportion of participants alive and discharged by Day 28 and Day 60","definition_or_measurement_approach":"Proportion of participants who are alive and discharged from hospital by Day 28 and by Day 60."}
  • {"endpoint_text":"- 12. Time to discharge","definition_or_measurement_approach":"Time from randomisation to hospital discharge."}
  • {"endpoint_text":"- 13. Time to being off supplemental oxygen","definition_or_measurement_approach":"Time from randomisation to cessation of supplemental oxygen therapy."}
  • {"endpoint_text":"- 14. WHO CPS score rank-based comparison","definition_or_measurement_approach":"Rank-based comparison using the WHO 10-category Clinical Progression Scale (CPS)."}
  • {"endpoint_text":"- 15. Presence of anti-drug antibodies","definition_or_measurement_approach":"Assessment of immunogenicity by measuring presence of anti-drug antibodies (ADA)."}
  • {"endpoint_text":"- 16. Baseline serum biomarker levels relative to primary endpoint","definition_or_measurement_approach":"Analysis of baseline serum biomarker levels in relation to the primary endpoint (association with outcome)."}

Recruitment

Planned Sample Size
2870
Recruitment Window Months
30
Consent Approach
Informed consent obtained from participants themselves; inclusion criterion requires adult participants ≥18 years at time of signing the ICF. Multiple subject information sheets and ICFs (including site-specific versions, addenda for future research, personal data, and separate materials for pregnant partners) are provided. Documents are available in multiple country/language-specific versions (examples in English, French, Spanish, Greek, Dutch, Bulgarian, Hungarian, Slovak, Italian, Polish, Czech and German as indicated by document titles).

Methods

  • Recruitment via participating hospital sites (site-based recruitment) using site recruitment arrangements documents.
  • Use of printed recruitment materials: posters, pamphlets, short information leaflets and study guides (documents named K2_Recruitment material Poster / Pamphlet / Short information / Quick Study Guide present).
  • Provision of study information and ICFs (subject information sheets and informed consent forms) at sites; site-specific ICFs and study information materials are available (multiple L1 SIS and ICF documents listed).

Geography

Total Number Of Sites
118
Total Number Of Participants
828

Slovakia

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
16-10-2024
Processing Time Days
252
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
University Hospital Bratislava
Department Name
Clinic of Pneumology, Phthisiology and functional diagnostics
Principal Investigator Name
Štefan Laššán
Principal Investigator Email
lassan@ru.unb.sk
Contact Person Name
Štefan Laššán
Contact Person Email
lassan@ru.unb.sk
Site Name
Univerzitna Nemocnica Martin
Department Name
Pneumology and Phtisiology Clinic
Principal Investigator Name
Ivan Kocan
Principal Investigator Email
ivan.kocan@unm.sk
Contact Person Name
Ivan Kocan
Contact Person Email
ivan.kocan@unm.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
Clinic of Infectious Diseases
Principal Investigator Name
Mária Soľavová
Principal Investigator Email
maria.solavova@fntt.sk
Contact Person Name
Mária Soľavová
Contact Person Email
maria.solavova@fntt.sk
Site Name
Fakultna Nemocnica Trnava
Department Name
Pneumology and Phtiseology Department
Principal Investigator Name
Miroslava Čulagová
Principal Investigator Email
miroslava.culagova@fntt.sk
Contact Person Name
Miroslava Čulagová
Contact Person Email
miroslava.culagova@fntt.sk
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Clinic of Pneumology and Phthisiology
Principal Investigator Name
Lenka Kopčová
Principal Investigator Email
lenka.kopcova@unlp.sk
Contact Person Name
Lenka Kopčová
Contact Person Email
lenka.kopcova@unlp.sk
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
Clinic of infectology and Travel Medicine
Principal Investigator Name
Pavol Jarčuška
Principal Investigator Email
jarcuska@gmail.com
Contact Person Name
Pavol Jarčuška
Contact Person Email
jarcuska@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
02-01-2026
Processing Time Days
333
Number Of Sites
11
Number Of Participants
60

Sites

Site Name
Medizinische Hochschule Hannover
Department Name
Medizinische Hochschule Hannover, Klinik für Pneumologie
Principal Investigator Name
Marius Hoeper
Principal Investigator Email
Hoeper.marius@mh-hannover.de
Contact Person Name
Marius Hoeper
Contact Person Email
Hoeper.marius@mh-hannover.de
Site Name
Rostock University Medical Center
Department Name
Abteilung für Tropenmedizin und Infektionskrankheiten
Principal Investigator Name
Micha Löbermann
Principal Investigator Email
micha.loebermann@med.uni-rostock.de
Contact Person Name
Micha Löbermann
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin I
Principal Investigator Name
Stephan Schmid
Principal Investigator Email
Stephan.Schmid@ukr.de
Contact Person Name
Stephan Schmid
Contact Person Email
Stephan.Schmid@ukr.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
Klinik für Innere Medizin - Pneumologie und Intensivmedizin
Principal Investigator Name
Barbara Weckler
Principal Investigator Email
barbara.weckler@uni-marburg.de
Contact Person Name
Barbara Weckler
Contact Person Email
barbara.weckler@uni-marburg.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Pneumologie / Infektiologie
Principal Investigator Name
Martin Witzenrath
Principal Investigator Email
martin.witzenrath@charite.de
Contact Person Name
Martin Witzenrath
Contact Person Email
martin.witzenrath@charite.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Innere Medizin
Principal Investigator Name
Stefan Schmiedel
Principal Investigator Email
s.schmiedel@uke.de
Contact Person Name
Stefan Schmiedel
Contact Person Email
s.schmiedel@uke.de
Site Name
Universitaetsklinikum Augsburg
Department Name
III. Medizinische Klinik
Principal Investigator Name
André Fuchs
Principal Investigator Email
andre.fuchs@uk-augsburg.de
Contact Person Name
André Fuchs
Contact Person Email
andre.fuchs@uk-augsburg.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Innere Medizin - Pneumologie und Infektiologie
Principal Investigator Name
Sven Gläser
Principal Investigator Email
Sven.Glaeser@vivantes.de
Contact Person Name
Sven Gläser
Contact Person Email
Sven.Glaeser@vivantes.de
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Lungenklinik
Principal Investigator Name
Christian Karagiannidis
Principal Investigator Email
karagiannidisc@kliniken-koeln.de
Contact Person Name
Christian Karagiannidis
Site Name
Romed Klinikum Rosenheim
Department Name
RoMed Klinikum Rosenheim Medizinische Klinik III
Principal Investigator Name
Stephan Budweiser
Principal Investigator Email
stephan.budweiser@ro-med.de
Contact Person Name
Stephan Budweiser
Contact Person Email
stephan.budweiser@ro-med.de
Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Innere Medizin I, Pneumologie
Principal Investigator Name
Jan Heyckendorf
Principal Investigator Email
jan.heyckendorf@uksh.de
Contact Person Name
Jan Heyckendorf
Contact Person Email
jan.heyckendorf@uksh.de

Hungary

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
14-05-2024
Processing Time Days
97
Number Of Sites
7
Number Of Participants
77

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Sürgősségi Betegellátó Osztály
Principal Investigator Name
Krisztina Varga
Principal Investigator Email
sbotitkarsag@petz.gyor.hu
Contact Person Name
Krisztina Varga
Contact Person Email
sbotitkarsag@petz.gyor.hu
Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Principal Investigator Name
Ildiko Kissne Horvath
Principal Investigator Email
horvath.ildiko@med.unideb.hu
Contact Person Name
Ildiko Kissne Horvath
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Dr. Kenessey Albert Korhaz Rendelointezet
Department Name
Tüdőgondozó Pulmonológia Krónikus Osztály
Principal Investigator Name
Magdolna Poczi
Principal Investigator Email
korhaz@kenessey.hu
Contact Person Name
Magdolna Poczi
Contact Person Email
korhaz@kenessey.hu
Site Name
University Of Pecs
Department Name
Sürgősségi Orvostani Tanszék Sürgősségi Betegellátó Osztály
Principal Investigator Name
Peter Laszlo Kanizsai
Principal Investigator Email
kanizsai.peter@pte.hu
Contact Person Name
Peter Laszlo Kanizsai
Contact Person Email
kanizsai.peter@pte.hu
Site Name
Semmelweis University
Department Name
Sürgősségi Orvostani Klinika
Principal Investigator Name
Csaba Varga
Principal Investigator Email
varga.csaba2@semmelweis.hu
Contact Person Name
Csaba Varga
Contact Person Email
varga.csaba2@semmelweis.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Jósa András Oktatókórház Infektológiai Osztály
Principal Investigator Name
Tibor Kiss
Principal Investigator Email
szszbmk@szszbmk.hu
Contact Person Name
Tibor Kiss
Contact Person Email
szszbmk@szszbmk.hu
Site Name
Koranyi National Institute For Pulmonology
Department Name
VIII. Pulmonológiai Osztály
Principal Investigator Name
Beatrix Simon
Principal Investigator Email
simon.beatrix@koranyi.hu
Contact Person Name
Beatrix Simon
Contact Person Email
simon.beatrix@koranyi.hu

Denmark

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
690
Number Of Sites
10
Number Of Participants
65

Sites

Site Name
Rigshospitalet
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Marie Helleberg
Principal Investigator Email
marie.helleberg@regionh.dk
Contact Person Name
Marie Helleberg
Contact Person Email
marie.helleberg@regionh.dk
Site Name
Sygehus Lillebælt
Department Name
Lungemedicinsk Forskningsenhed
Principal Investigator Name
Ole Hilberg
Principal Investigator Email
Ole.Hilberg@rsyd.dk
Contact Person Name
Ole Hilberg
Contact Person Email
Ole.Hilberg@rsyd.dk
Site Name
Aarhus Universitetshospital
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Nina Stærke
Principal Investigator Email
NINASE@rm.dk
Contact Person Name
Nina Stærke
Contact Person Email
NINASE@rm.dk
Site Name
Hvidovre Hospital
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Thomas Lars Benfield
Principal Investigator Email
Thomas.Lars.Benfield@regionh.dk
Contact Person Name
Thomas Lars Benfield
Site Name
Odense University Hospital
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Isik Somuncu Johansen
Principal Investigator Email
isik.somuncu.johansen@rsyd.dk
Contact Person Name
Isik Somuncu Johansen
Contact Person Email
isik.somuncu.johansen@rsyd.dk
Site Name
Kolding Sygehus
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Birgit Thorup Røge
Principal Investigator Email
Birgit.Thorup.Roege@rsyd.dk
Contact Person Name
Birgit Thorup Røge
Contact Person Email
Birgit.Thorup.Roege@rsyd.dk
Site Name
Nordsjaellands Hospital
Department Name
Lungemedicinsk og Infektionsmedicinsk Forskningsenhed
Principal Investigator Name
Birgitte Madsen
Principal Investigator Email
birgitte.lindegaard.madsen@regionh.dk
Contact Person Name
Birgitte Madsen
Site Name
Regionshospitalet Gødstrup
Department Name
Infektionsmedicinsk afdeling
Principal Investigator Name
Steffen Leth
Principal Investigator Email
stefleth@rm.dk
Contact Person Name
Steffen Leth
Contact Person Email
stefleth@rm.dk
Site Name
Aalborg University Hospital
Department Name
Lungemedicinsk Forskningsenhed
Principal Investigator Name
Ulla Møller Weinreich
Principal Investigator Email
ulw@rn.dk
Contact Person Name
Ulla Møller Weinreich
Contact Person Email
ulw@rn.dk
Site Name
Bispebjerg Hospital
Department Name
Afdeling for Lunge- og infektionssygdomme
Principal Investigator Name
Daria Podlekareva
Principal Investigator Email
daria.podlekareva.02@regionh.dk
Contact Person Name
Daria Podlekareva

France

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
682
Number Of Sites
13
Number Of Participants
65

Sites

Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Urgences Adultes
Principal Investigator Name
Damien Viglino
Principal Investigator Email
DViglino@chu-grenoble.fr
Contact Person Name
Damien Viglino
Contact Person Email
DViglino@chu-grenoble.fr
Site Name
Centre Hospitalier Regional D'Orleans
Department Name
Service de Médecine Intensive Réanimation
Principal Investigator Name
Grégoire Muller
Principal Investigator Email
gregoire.muller@chr-orleans.fr
Contact Person Name
Grégoire Muller
Contact Person Email
gregoire.muller@chr-orleans.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine Intensive Réanimation
Principal Investigator Name
Nicolas De Prost
Principal Investigator Email
Nicolas.de-prost@aphp.fr
Contact Person Name
Nicolas De Prost
Contact Person Email
Nicolas.de-prost@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Médecine Intensive
Principal Investigator Name
Yonatan Perez
Principal Investigator Email
yonatan.perez@chru-strasbourg.fr
Contact Person Name
Yonatan Perez
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service de Médecine Intensive Réanimation
Principal Investigator Name
Jean-Pierre Quenot
Principal Investigator Email
jean-pierre.quenot@chu-dijon.fr
Contact Person Name
Jean-Pierre Quenot
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service de Pneumologie
Principal Investigator Name
Claire Andrejak
Principal Investigator Email
Andrejak.claire@chu-amiens.fr
Contact Person Name
Claire Andrejak
Contact Person Email
Andrejak.claire@chu-amiens.fr
Site Name
Les Hopitaux De Chartres
Department Name
Service de Pneumologie
Principal Investigator Name
Anissa Berraies
Principal Investigator Email
aberraies@ch-chartres.fr
Contact Person Name
Anissa Berraies
Contact Person Email
aberraies@ch-chartres.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Département de Médecine Intensive Réanimation et Médecine Hyperbare
Principal Investigator Name
Pierre Asfar
Principal Investigator Email
PiAsfar@chu-angers.fr
Contact Person Name
Pierre Asfar
Contact Person Email
PiAsfar@chu-angers.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Département Médecine Intensive Réanimation
Principal Investigator Name
Emmanuelle Mercier
Principal Investigator Email
emmanuelle.mercier@chu-tours.fr
Contact Person Name
Emmanuelle Mercier
Site Name
CHRU de Brest - Hôpital de la cavale Blanche
Department Name
Centre d'Investigation Clinique
Principal Investigator Name
Francis Couturaud
Principal Investigator Email
francis.couturaud@chu-brest.fr
Contact Person Name
Francis Couturaud
Contact Person Email
francis.couturaud@chu-brest.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Médecine Intensive - Réanimation
Principal Investigator Name
Ferhat Meziani
Principal Investigator Email
ferhat.meziani@chru-strasbourg.fr
Contact Person Name
Ferhat Meziani
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service des maladies respiratoires
Principal Investigator Name
Arnaud Bourdin
Principal Investigator Email
a-bourdin@chu-montpellier.fr
Contact Person Name
Arnaud Bourdin
Contact Person Email
a-bourdin@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Institut du Thorax - Service de Pneumologie
Principal Investigator Name
François-Xavier Blanc
Principal Investigator Email
xavier.blanc@chu-nantes.fr
Contact Person Name
François-Xavier Blanc
Contact Person Email
xavier.blanc@chu-nantes.fr

Bulgaria

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
24-02-2025
Processing Time Days
382
Number Of Sites
10
Number Of Participants
75

Sites

Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Second Department for Intensive care
Principal Investigator Name
Borislav Velev
Principal Investigator Email
borovelev@abv.bg
Contact Person Name
Borislav Velev
Contact Person Email
borovelev@abv.bg
Site Name
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Department Name
Department of Pneumonology
Principal Investigator Name
Hristo Metev
Principal Investigator Email
h_metev_2003@yahoo.com
Contact Person Name
Hristo Metev
Contact Person Email
h_metev_2003@yahoo.com
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Clinic of pneumology
Principal Investigator Name
Anton Penev
Principal Investigator Email
anton.penev@abv.bg
Contact Person Name
Anton Penev
Contact Person Email
anton.penev@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of pneumology and phtisiatry
Principal Investigator Name
Vladimir Hodzhev
Principal Investigator Email
vhodzhev@pulmonology-plovdiv.info
Contact Person Name
Vladimir Hodzhev
Site Name
Specialized Hospital For Active Treatment Of Pulmonary Diseases Pernik EOOD
Department Name
Pulmology department
Principal Investigator Name
Galina Petrova
Principal Investigator Email
galinalpetrova@abv.bg
Contact Person Name
Galina Petrova
Contact Person Email
galinalpetrova@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Pneumology department
Principal Investigator Name
Kiril Alexandrov
Principal Investigator Email
k_alexandrov@abv.bg
Contact Person Name
Kiril Alexandrov
Contact Person Email
k_alexandrov@abv.bg
Site Name
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Department Name
Department of pneumology and phtisiatry
Principal Investigator Name
Lidiya Nikolcheva-Todorova
Principal Investigator Email
dr.lidiya.nikolcheva@gmail.com
Contact Person Name
Lidiya Nikolcheva-Todorova
Contact Person Email
dr.lidiya.nikolcheva@gmail.com
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
First Department of Pneumonology and Phthisiatry
Principal Investigator Name
Iliya Krachunov
Principal Investigator Email
i.krachunov.pn@heartandbrain.bg
Contact Person Name
Iliya Krachunov
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of internal diseases
Principal Investigator Name
Diana Slaveva
Principal Investigator Email
diana.slaveva@abv.bg
Contact Person Name
Diana Slaveva
Contact Person Email
diana.slaveva@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD (additional site entry)
Department Name
Pneumology department
Principal Investigator Name
Kiril Alexandrov
Principal Investigator Email
k_alexandrov@abv.bg
Contact Person Name
Kiril Alexandrov
Contact Person Email
k_alexandrov@abv.bg

Romania

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
524
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Sibiu
Department Name
Adults Infectious Diseases Clinical Department
Principal Investigator Name
Victoria Birlutiu
Principal Investigator Email
secretariat@scjus.ro
Contact Person Name
Victoria Birlutiu
Contact Person Email
secretariat@scjus.ro
Site Name
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Department Name
Clinica Pneumologie I
Principal Investigator Name
Stefan Frent
Principal Investigator Email
oancea@umft.ro
Contact Person Name
Stefan Frent
Contact Person Email
oancea@umft.ro
Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Department Name
Infectious Diseases Department
Principal Investigator Name
Anca Streinu-Cercel
Principal Investigator Email
anca.streinucercel@gmail.com
Contact Person Name
Anca Streinu-Cercel
Contact Person Email
anca.streinucercel@gmail.com
Site Name
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Department Name
Sectia I
Principal Investigator Name
Andrei Vata
Principal Investigator Email
secretariat@infectioase.ro
Contact Person Name
Andrei Vata
Contact Person Email
secretariat@infectioase.ro
Site Name
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Department Name
Ambulatoriului Clinic Integrat al SUUMC, Pneumologie
Principal Investigator Name
Andrei Luca
Principal Investigator Email
lc_andrei@yahoo.com
Contact Person Name
Andrei Luca
Contact Person Email
lc_andrei@yahoo.com
Site Name
Spitalul Clinic De Boli Infectioase Constanta
Department Name
Secţia Boli Infecţioase Adulţi II
Principal Investigator Name
Irina Dumitru
Principal Investigator Email
roxana.cernat@seanet.ro
Contact Person Name
Irina Dumitru
Contact Person Email
roxana.cernat@seanet.ro
Site Name
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Department Name
Infectious Diseases Clinical Department
Principal Investigator Name
Violeta Tincuta Briciu
Principal Investigator Email
directormedical@infectioasecluj.ro
Contact Person Name
Violeta Tincuta Briciu

Poland

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
04-01-2026
Processing Time Days
693
Number Of Sites
10
Number Of Participants
20

Sites

Site Name
INSTYTUT GRUŹLICY I CHORÓB PŁUC
Department Name
II Klinika Chorob Pluc
Principal Investigator Name
Pawel Sliwinski
Principal Investigator Email
p.sliwinski@wp.pl
Contact Person Name
Pawel Sliwinski
Contact Person Email
p.sliwinski@wp.pl
Site Name
Wojewódzki Szpital Specjalistyczny Im. J. Gromkowskiego
Department Name
I Oddzial Chorob Zakaznych
Principal Investigator Name
Krzysztof Simon
Principal Investigator Email
krzysimon@gmail.com
Contact Person Name
Krzysztof Simon
Contact Person Email
krzysimon@gmail.com
Site Name
Centrum Medyczne W Lancucie Sp. z o.o.
Department Name
Kliniczny Oddzial Chorob Zakaznych z Pododdzialem Hepatologicznym
Principal Investigator Name
Robert Plesniak
Principal Investigator Email
robert.plesniak@wp.pl
Contact Person Name
Robert Plesniak
Contact Person Email
robert.plesniak@wp.pl
Site Name
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
Department Name
Oddzial Chorob Wewnetrznych i Geriatrii
Principal Investigator Name
Sebastian Slomka
Principal Investigator Email
sslomka@wp.pl
Contact Person Name
Sebastian Slomka
Contact Person Email
sslomka@wp.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
Department Name
Oddzial Kliniczny Chorob Wewnetrznych i Gerontokardiologii
Principal Investigator Name
Piotr Jankowski
Principal Investigator Email
piotrjankowski@interia.pl
Contact Person Name
Piotr Jankowski
Contact Person Email
piotrjankowski@interia.pl
Site Name
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Department Name
Klinika Chorob Wewnetrznych, Infekcyjnych i Alergologii
Principal Investigator Name
Andrzej Chcialowski
Principal Investigator Email
achcialowski@wim.mil.pl
Contact Person Name
Andrzej Chcialowski
Contact Person Email
achcialowski@wim.mil.pl
Site Name
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Department Name
Podkarpackie Centrum Chorob Pluc w Rzeszowie Klinika Pulmonologii z Pododdzialem Alergologii
Principal Investigator Name
Slawomir Tokarski
Principal Investigator Email
tokarski@onet.eu
Contact Person Name
Slawomir Tokarski
Contact Person Email
tokarski@onet.eu
Site Name
Szpital Powiatowy W Chrzanowie
Department Name
Oddzial Chorob Pluc
Principal Investigator Name
Rafal Harat
Principal Investigator Email
haratb@interia.pl
Contact Person Name
Rafal Harat
Contact Person Email
haratb@interia.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej
Department Name
Oddzial Chorob Wewnetrznych w Lecznej
Principal Investigator Name
Marcin Skorski
Principal Investigator Email
skorski_marcin@interia.pl
Contact Person Name
Marcin Skorski
Contact Person Email
skorski_marcin@interia.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. J. Gromkowskiego (additional site entry)
Department Name
I Oddzial Chorob Zakaznych
Principal Investigator Name
Krzysztof Simon
Principal Investigator Email
krzysimon@gmail.com
Contact Person Name
Krzysztof Simon
Contact Person Email
krzysimon@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
22-01-2025
Processing Time Days
381
Number Of Sites
7
Number Of Participants
93

Sites

Site Name
Hospital Del Mar
Department Name
Neumology
Principal Investigator Name
Esther Barreiro Portela
Principal Investigator Email
ebarreiro@imim.es
Contact Person Name
Esther Barreiro Portela
Contact Person Email
ebarreiro@imim.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neumology
Principal Investigator Name
Rosa Maria Nieto Royo
Principal Investigator Email
rosanr23@hotmail.com
Contact Person Name
Rosa Maria Nieto Royo
Contact Person Email
rosanr23@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Neumology
Principal Investigator Name
Silvia Aguado Ibañez
Principal Investigator Email
s.aguado.ibanez@gmail.com
Contact Person Name
Silvia Aguado Ibañez
Contact Person Email
s.aguado.ibanez@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neumology
Principal Investigator Name
Jose Manuel Cifrian Martinez
Principal Investigator Email
josemanuel.cifrian@scsalud.es
Contact Person Name
Jose Manuel Cifrian Martinez
Contact Person Email
josemanuel.cifrian@scsalud.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda (additional site entry)
Department Name
Neumology
Principal Investigator Name
Silvia Aguado Ibañez
Principal Investigator Email
s.aguado.ibanez@gmail.com
Contact Person Name
Silvia Aguado Ibañez
Contact Person Email
s.aguado.ibanez@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Neumology
Principal Investigator Name
Jaime Signes-Costa Miñana
Principal Investigator Email
jaimesignescosta@gmail.com
Contact Person Name
Jaime Signes-Costa Miñana
Contact Person Email
jaimesignescosta@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Neumology
Principal Investigator Name
Jose Luis Velasco Garrido
Principal Investigator Email
jlvelascogarrido@hotmail.com
Contact Person Name
Jose Luis Velasco Garrido
Contact Person Email
jlvelascogarrido@hotmail.com

Greece

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
700
Number Of Sites
6
Number Of Participants
177

Sites

Site Name
University General Hospital Of Heraklion
Department Name
Internal Medicine Clinic
Principal Investigator Name
Diamantis Kofteridis
Principal Investigator Email
kofterid@med.uoc.gr
Contact Person Name
Diamantis Kofteridis
Contact Person Email
kofterid@med.uoc.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd Department of Internal Medicine and Laboratory
Principal Investigator Name
Garyfallia Poulakou
Principal Investigator Email
gpoulakou@gmail.com
Contact Person Name
Garyfallia Poulakou
Contact Person Email
gpoulakou@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
NHS Pulmonary Clinic
Principal Investigator Name
Stavros Tryfon
Principal Investigator Email
stavrostryfon@yahoo.gr
Contact Person Name
Stavros Tryfon
Contact Person Email
stavrostryfon@yahoo.gr
Site Name
University General Hospital Of Ioannina
Department Name
Respiratory Clinic
Principal Investigator Name
Konstantinos Kostikas
Principal Investigator Email
ktkostikas@gmail.com
Contact Person Name
Konstantinos Kostikas
Contact Person Email
ktkostikas@gmail.com
Site Name
University General Hospital Attikon
Department Name
4rth Department of Internal Medicine, Rheumatology and Clinical Immunology
Principal Investigator Name
Dimitrios Boumpas
Principal Investigator Email
dpathologiki@gmail.com
Contact Person Name
Dimitrios Boumpas
Contact Person Email
dpathologiki@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou (additional site entry)
Department Name
University Pulmonary Clinic
Principal Investigator Name
Konstantinos Porpodis
Principal Investigator Email
kporpodis@yahoo.gr
Contact Person Name
Konstantinos Porpodis
Contact Person Email
kporpodis@yahoo.gr

Italy

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
697
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Azienda USL Toscana Sud Est
Department Name
Unità Operativa di Pneumologia
Principal Investigator Name
Raffaele Scala
Principal Investigator Email
raffaele.scala@uslsudest.toscana.it
Contact Person Name
Raffaele Scala
Site Name
National Institute For Infectious Diseases Lazzaro Spallanzani
Department Name
U.O.C. Malattie Infettive dell’Apparato Respiratorio
Principal Investigator Name
Fabrizio Palmieri
Principal Investigator Email
fabrizio.palmieri@inmi.it
Contact Person Name
Fabrizio Palmieri
Contact Person Email
fabrizio.palmieri@inmi.it
Site Name
Azienda Sanitaria Locale Citta Di Torino
Department Name
Dipartimento di Scienze Mediche – Malattie infettive
Principal Investigator Name
Andrea Calcagno
Principal Investigator Email
andrea.calcagno@unito.it
Contact Person Name
Andrea Calcagno
Contact Person Email
andrea.calcagno@unito.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico
Department Name
UOC Medicina Interna
Principal Investigator Name
Raffaele Antonelli Incalzi
Principal Investigator Email
R.Antonelli@policlinicocampus.it
Contact Person Name
Raffaele Antonelli Incalzi
Site Name
Humanitas Research Hospital
Department Name
UO Pneumologia 1
Principal Investigator Name
Anna Stainer
Principal Investigator Email
anna.stainer@hunimed.eu
Contact Person Name
Anna Stainer
Contact Person Email
anna.stainer@hunimed.eu
Site Name
Azienda Ospedaliera Dei Colli
Department Name
Dipartimento di Pneumologia e Oncologia - U.O.C. Clinica Pneumologica SUN
Principal Investigator Name
Andrea Bianco
Principal Investigator Email
ANDREA.BIANCO@unicampania.it
Contact Person Name
Andrea Bianco
Contact Person Email
ANDREA.BIANCO@unicampania.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Dipartimento di Medicina - U.O. C. Malattie infettive 2
Principal Investigator Name
Alberto Matteelli
Principal Investigator Email
alberto.matteelli@unibs.it
Contact Person Name
Alberto Matteelli
Contact Person Email
alberto.matteelli@unibs.it
Site Name
Azienda USL Toscana Sud Est (additional site entry)
Department Name
Unità Operativa di Pneumologia
Principal Investigator Name
Raffaele Scala
Principal Investigator Email
raffaele.scala@uslsudest.toscana.it
Contact Person Name
Raffaele Scala

Czechia

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
700
Number Of Sites
10
Number Of Participants
45

Sites

Site Name
Nemocnice Rudolfa a Stefanie Benešov, a. s.
Department Name
Interní oddělení
Principal Investigator Name
Miroslav Urbánek
Principal Investigator Email
miroslav.urbanek@hospital-bn.cz
Contact Person Name
Miroslav Urbánek
Site Name
Fakultni Nemocnice Bulovka
Department Name
Anesteziologicko resuscitační oddělení
Principal Investigator Name
Jan Beneš
Principal Investigator Email
jan.benes@bulovka.cz
Contact Person Name
Jan Beneš
Contact Person Email
jan.benes@bulovka.cz
Site Name
Oblastni nemocnice Kolin a.s.
Department Name
Resuscitační oddělení a víceoborová JIP
Principal Investigator Name
Martin Nováček
Principal Investigator Email
martin.novacek@nemocnicekolin.cz
Contact Person Name
Martin Nováček
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika infekčních chorob
Principal Investigator Name
Radana Pařízková
Principal Investigator Email
parizkova.radana@fnbrno.cz
Contact Person Name
Radana Pařízková
Contact Person Email
parizkova.radana@fnbrno.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Interní klinika
Principal Investigator Name
Monika Grussmannová
Principal Investigator Email
monika.grussmannova@fnkv.cz
Contact Person Name
Monika Grussmannová
Contact Person Email
monika.grussmannova@fnkv.cz
Site Name
Nemocnice Na Homolce
Department Name
Interní oddělení
Principal Investigator Name
Petr Blaha
Principal Investigator Email
petr.blaha@homolka.cz
Contact Person Name
Petr Blaha
Contact Person Email
petr.blaha@homolka.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika infekčních nemocí
Principal Investigator Name
Jan Machač
Principal Investigator Email
jan.machac@fnhk.cz
Contact Person Name
Jan Machač
Contact Person Email
jan.machac@fnhk.cz
Site Name
Nemocnice Kyjov
Department Name
Infekční oddělení
Principal Investigator Name
Josef Blažek
Principal Investigator Email
blazek.josef@nemkyj.cz
Contact Person Name
Josef Blažek
Contact Person Email
blazek.josef@nemkyj.cz
Site Name
Oblastni nemocnice Mlada Boleslav a.s.
Department Name
Plicní oddělení
Principal Investigator Name
Tomáš Dvořák
Principal Investigator Email
tomas.dvorak@onmb.cz
Contact Person Name
Tomáš Dvořák
Contact Person Email
tomas.dvorak@onmb.cz
Site Name
Fakultni Nemocnice Brno (additional site entry)
Department Name
Klinika infekčních chorob
Principal Investigator Name
Radana Pařízková
Principal Investigator Email
parizkova.radana@fnbrno.cz
Contact Person Name
Radana Pařízková
Contact Person Email
parizkova.radana@fnbrno.cz

Sweden

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
09-01-2026
Processing Time Days
703
Number Of Sites
9
Number Of Participants
32

Sites

Site Name
Region Skane Skanes Universitetssjukhus (Malmo)
Department Name
Infektionsmottagningen, Ruth Lundskogs gata 3, 20502, Malmö
Principal Investigator Name
Maria Eklund Josephson
Principal Investigator Email
Maria.EklundJosephson@skane.se
Contact Person Name
Maria Eklund Josephson
Contact Person Email
Maria.EklundJosephson@skane.se
Site Name
Region Skane Skanes Universitetssjukhus (Lund)
Department Name
Infektionsmottagningen, Hälsogatan 3, 22185 Lund
Principal Investigator Name
Lisa Påhlman
Principal Investigator Email
lisa.pahlman@med.lu.se
Contact Person Name
Lisa Påhlman
Contact Person Email
lisa.pahlman@med.lu.se
Site Name
Danderyds Sjukhus AB
Department Name
VO Internmedicin och Infektion, Entrevägen 2, 18288 Stockholm
Principal Investigator Name
Johan Ursing
Principal Investigator Email
johan.ursing@regionstockholm.se
Contact Person Name
Johan Ursing
Site Name
Karolinska University Hospital
Department Name
Infektionsavdelningen, Ambulansgatan 12B, 14157, Huddinge
Principal Investigator Name
Peter Eriksson
Principal Investigator Email
Peter.eriksson@regionstockholm.se
Contact Person Name
Peter Eriksson
Site Name
Region Skane Helsingborg Hospital
Department Name
Infektionsmottagningen
Principal Investigator Name
Jonas Tverring
Principal Investigator Email
Jonas.Tverring@skane.se
Contact Person Name
Jonas Tverring
Contact Person Email
Jonas.Tverring@skane.se
Site Name
Soedersjukhuset AB
Department Name
Infektionskliniken/Venhälsan Södersjukhuset AB
Principal Investigator Name
Viktor Dahl
Principal Investigator Email
viktor.dahl@regionstockholm.se
Contact Person Name
Viktor Dahl
Contact Person Email
viktor.dahl@regionstockholm.se
Site Name
Västmanlands sjukhus Västerås
Department Name
Infektionsmottagningen
Principal Investigator Name
Emeli Månsson
Principal Investigator Email
anders.krifors@regionvastmanland.se
Contact Person Name
Emeli Månsson
Site Name
Region Vaesterbotten
Department Name
Norrlands Universitetssjukhus, Infektionsmottagningen
Principal Investigator Name
Johan Rasmuson
Principal Investigator Email
Johan.Rasmuson@regionvasterbotten.se
Contact Person Name
Johan Rasmuson
Site Name
Region Skane Skanes Universitetssjukhus (Lund additional)
Department Name
Infektionsmottagningen
Principal Investigator Name
Lisa Påhlman
Principal Investigator Email
lisa.pahlman@med.lu.se
Contact Person Name
Lisa Påhlman
Contact Person Email
lisa.pahlman@med.lu.se

Belgium

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
754
Number Of Sites
4
Number Of Participants
34

Sites

Site Name
UCL Mont-Godinne
Department Name
Soins Intensifs
Principal Investigator Name
Pierre Bulpa
Principal Investigator Email
pierre.bulpa@chuuclnamur.uclouvain.be
Contact Person Name
Pierre Bulpa
Site Name
Clinique Saint-Pierre
Department Name
Soins Intensifs
Principal Investigator Name
Nicolas De Schryver
Principal Investigator Email
nicolas.deschryver@cspo.be
Contact Person Name
Nicolas De Schryver
Contact Person Email
nicolas.deschryver@cspo.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Longziekten
Principal Investigator Name
Bernard Bouckaert
Principal Investigator Email
bernard.bouckaert@azdelta.be
Contact Person Name
Bernard Bouckaert
Contact Person Email
bernard.bouckaert@azdelta.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Longziekten
Principal Investigator Name
Mathias Leys
Principal Investigator Email
mathias.leys@azgroeninge.be
Contact Person Name
Mathias Leys
Contact Person Email
mathias.leys@azgroeninge.be

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Tozorakimab
Active Substance
TOZORAKIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
prodAuthStatus: 1; euMpNumber: PRD9978244
Frequency
Single dose
Investigational Product Name
Tozorakimab-placebo
Modality
Other
Frequency
Single dose (matching placebo)
Combination Treatment
Yes

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