Randomized placebo controlled assessment of safety and efficacy of inhaled Aloxistatin (E64D) in 24 patients with CoViD-19. (CoViD-19-Aloxistatin)

  • Funded by Bundesministerium für Bildung und Forschung [German Federal Ministry of Education and Research] (BMBF)
  • Total publications:0 publications

Grant number: 01KI20386

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Known Financial Commitments (USD)

    $2,730,249.11
  • Funder

    Bundesministerium für Bildung und Forschung [German Federal Ministry of Education and Research] (BMBF)
  • Principal Investigator

    Dr. Sebastian Fähndrich
  • Research Location

    Germany
  • Lead Research Institution

    Universitätsklinikum Freiburg
  • Research Priority Alignment

    N/A
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Pre-clinical studies

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase I

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

The aim of this clinical study is to avoid severe courses of COVID-19 and thus reduce mortality from the disease. For this purpose, the safety and effectiveness of inhaled aloxistatin is checked in this project. For SARS-CoV-2 to be infectious, the virus must first be activated by various biochemical processes and penetrate the human host cells in sufficiently high concentrations. Aloxistatin is a protease inhibitor and - as already shown in mouse coronavirus model systems - prevents this activation of the virus at a crucial point. Building on the work already carried out, the preclinical testing of the inhalation of aloxistatin in an animal model and in a phase I clinical trial in humans will now be investigated. Inhaling the active ingredient should lead to higher doses of the active ingredient being achieved on site and the virus being inhibited shortly after infection. This should prevent severe disease progression from the start.