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 - Sorbonne Université Access content directly
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

Stephanie Dauth
  • Function : Author
Ann Christina Foldenauer
  • Function : Author
Anita Bulczak-Schadendorf
  • Function : Author
Francisco Maio Matos
  • Function : Author
Antoinette D. I. Van Asselt
  • Function : Author
Vilma Traskaite Juskeviciene
  • Function : Author
Coen D. A. Stehouwer
  • Function : Author
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.

Dates and versions

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

Identifiers

Cite

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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