Potential of FX06 to Prevent Disease Progression in Hospitalized Non-Intubated COVID-19 Patients \textemdash the Randomized, EU-wide, Placebo-Controlled, Phase II Study Design of IXION

Jan Kloka; Benjamin Friedrichson; Stephanie Dauth; Ann Christina Foldenauer; Anita Bulczak-Schadendorf; Maria J. G. T. Vehreschild; Francisco Maio Matos; Antoni Riera-Mestre; Antoinette D. I. Van Asselt; Edoardo de Robertis; Vilma Traskaite Juskeviciene; Patrick Meybohm; Dana Tomescu; Karine Lacombe; Coen D. A. Stehouwer; Kai Zacharowski; Oliver Old; Markus Ketomaeki; Lea Grebe; Patrick Booms; Simone Lindau; Sebastian Zinn; Isabel Maushagen; Timo Wolf; Christoph Stephan; Cathy Weynants; Sylvia Daamen; Petra Wülfroth; Thomas Steiner; Marinus Van Hulst; Peter Kranke; Sebastian Hottenrott; Tobias Schlesinger; Benedikt Schmid; Daniel Röder; Eva Kranke; Tobias Haas; Philipp Schlesinger; Magdalena Sitter; Davide Valeri; Raquel Torres Iglesias; José Maria Mora-Luján; Adriana Iriarte; Pau Cerdà; Neringa Vaguliene; Andrius Macas; Jolanta Litviniene; Kristina Balne; Catarina Monteiro; Inês Antunes Ferreira; Patricia Couceiro; Pedro Soares; Sofia Beirão; Yasmine Abi Aad; Thibault Chiarabini; Mihai Popescu; C. J. H. van Der Kallen

doi:10.1186/s13063-022-06609-x

Journal Articles Trials Year : 2022

Potential of FX06 to Prevent Disease Progression in Hospitalized Non-Intubated COVID-19 Patients \textemdash the Randomized, EU-wide, Placebo-Controlled, Phase II Study Design of IXION

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Jan Kloka

Function : Author

Goethe-Universität Frankfurt am Main

Benjamin Friedrichson

Function : Author

Goethe-Universität Frankfurt am Main

Stephanie Dauth

Function : Author

Ann Christina Foldenauer

Function : Author

Anita Bulczak-Schadendorf

Function : Author

Maria J. G. T. Vehreschild

Function : Author

Goethe-Universität Frankfurt am Main

Francisco Maio Matos

Function : Author

Antoni Riera-Mestre

Function : Author

Institut d'Investigació Biomèdica de Bellvitge [Barcelone]

Antoinette D. I. Van Asselt

Function : Author

Edoardo de Robertis

Function : Author

Università degli Studi di Perugia = University of Perugia

Vilma Traskaite Juskeviciene

Function : Author

Patrick Meybohm

Function : Author

University Hospital of Würzburg

Dana Tomescu

Function : Author

Fundeni Clinical Institute = Institutul Clinic Fundeni [Bucarest, Roumanie]

Karine Lacombe

Function : Author

Institut Pierre Louis d'Epidémiologie et de Santé Publique

CHU Saint-Antoine [AP-HP]

Coen D. A. Stehouwer

Function : Author

Kai Zacharowski

Function : Author

Goethe-Universität Frankfurt am Main

Oliver Old

Function : Author

Markus Ketomaeki

Function : Author

Lea Grebe

Function : Author

Patrick Booms

Function : Author

Simone Lindau

Function : Author

Sebastian Zinn

Function : Author

Isabel Maushagen

Function : Author

Timo Wolf

Function : Author

Christoph Stephan

Function : Author

Cathy Weynants

Function : Author

Sylvia Daamen

Function : Author

Petra Wülfroth

Function : Author

Thomas Steiner

Function : Author

Marinus Van Hulst

Function : Author

Peter Kranke

Function : Author

Sebastian Hottenrott

Function : Author

Tobias Schlesinger

Function : Author

Benedikt Schmid

Function : Author

Daniel Röder

Function : Author

Eva Kranke

Function : Author

Tobias Haas

Function : Author

Philipp Schlesinger

Function : Author

Magdalena Sitter

Function : Author

Davide Valeri

Function : Author

Raquel Torres Iglesias

Function : Author

José Maria Mora-Luján

Function : Author

Adriana Iriarte

Function : Author

Pau Cerdà

Function : Author

Neringa Vaguliene

Function : Author

Andrius Macas

Function : Author

Jolanta Litviniene

Function : Author

Kristina Balne

Function : Author

Catarina Monteiro

Function : Author

Inês Antunes Ferreira

Function : Author

Patricia Couceiro

Function : Author

Pedro Soares

Function : Author

Sofia Beirão

Function : Author

Yasmine Abi Aad

Function : Author

Thibault Chiarabini

Function : Author

Mihai Popescu

Function : Author

C. J. H. van Der Kallen

Function : Author

Abstract

Abstract Background More than 2.7 million hospitalizations of COVID-19-infected patients have occurred in Europe alone since the outbreak of the coronavirus in 2020. Interventions against SARS-CoV-2 are still in high need to prevent admissions to ICUs worldwide. FX06, a naturally occurring peptide in humans and other mammals, has the potential to reduce capillary leak by improving endothelial dysfunction and thus preventing the deterioration of patients. With IXION, we want to investigate the potential of FX06 to prevent disease progression in hospitalized, non-intubated COVID-19 patients. Methods IXION is an EU-wide, multicentre, placebo-controlled, double-blinded, parallel, randomized (2:1) phase II clinical study. Patient recruitment will start in September 2022 (to Q2/2023) in Germany, Italy, Lithuania, Spain, Romania, Portugal, and France. A total of 306 hospitalized patients (≥q 18 years and < 75 years) with a positive SARS-CoV-2 PCR test and a COVID-19 severity of 4\textendash 6 according to the WHO scale will be enrolled. After randomization to FX06 or placebo, patients will be assessed until day 28 (and followed up until day 60). FX06 (2 \texttimes 200 mg per day) or placebo will be administered intravenously for 5 consecutive days. The primary endpoint is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo. Secondary endpoints are lung function, oxygen saturation and breathing rate, systemic inflammation, survival, capillary refill time, duration of hospital stay, and drug accountability. Discussion With IXION, the multidisciplinary consortium aims to deliver a new therapy in addition to standard care against SARS-CoV-2 for the clinical management of COVID-19 during mild and moderate stages. Potential limitations might refer to a lack of recruiting and drop-out due to various possible protocol violations. While we controlled for drop-outs in the same size estimation, recruitment problems may be subject to external problems difficult to control for. Trial registration EudraCT 2021-005059-35 . Registered on 12 December 2021. Study Code TMP-2204-2021-47.

Domains

Life Sciences [q-bio]

Gestionnaire HAL 4 Sorbonne Université : Connect in order to contact the contributor

https://hal.sorbonne-universite.fr/hal-03843712

Submitted on : Tuesday, November 8, 2022-12:30:52 PM

Last modification on : Saturday, October 7, 2023-9:36:21 PM

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hal-03843712 , version 1 (08-11-2022)

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HAL Id : hal-03843712 , version 1
DOI : 10.1186/s13063-022-06609-x

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Jan Kloka, Benjamin Friedrichson, Stephanie Dauth, Ann Christina Foldenauer, Anita Bulczak-Schadendorf, et al.. Potential of FX06 to Prevent Disease Progression in Hospitalized Non-Intubated COVID-19 Patients \textemdash the Randomized, EU-wide, Placebo-Controlled, Phase II Study Design of IXION. Trials, 2022, 23 (1), pp.688. ⟨10.1186/s13063-022-06609-x⟩. ⟨hal-03843712⟩

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Potential of FX06 to Prevent Disease Progression in Hospitalized Non-Intubated COVID-19 Patients \textemdash the Randomized, EU-wide, Placebo-Controlled, Phase II Study Design of IXION

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