Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia (GI-COVID)

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

Grant number: 01KI20237

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Known Financial Commitments (USD)

    $2,148,006.78
  • Funder

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

    Pending
  • Research Location

    Germany, Europe
  • Lead Research Institution

    Justus-Liebig-Universität Gießen
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Clinical trial (unspecified trial phase)

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

In December 2019, an outbreak of viral pneumonia was observed in China which developed into a pandemic. A new type of corona virus (Sars-CoV-2) is considered to be the cause of this disease, which is known as COVID-19. In the course of COVID-19, pneumonia occurs in some cases, which can develop into an acute, life-threatening lung failure (respiratory distress syndrome, ARDS). This leads to destruction of the lung structure, which makes artificial respiration through a mask or intubation tube necessary. There is currently no specific therapy for COVID-19. The planned randomized, placebo-controlled clinical trial will investigate the efficacy of the drug substance Molgramostim (trade name Molgradex®) by inhalation in patients with COVID-19 pneumonia. Molgramostim promotes the formation and activation of immune cells and a similar preparation (sagramostim) is approved and used in the USA in a different dosage form in immunocompromised patients. Preclinical studies of Molgramostim and first applications of Sagramostim in patients with severe lung infections with organ failure have shown that inhaled administration significantly enhances the immune response of the lungs while accelerating the regeneration of lung tissue. The aim of this study is to measure whether the administration of Molgramostim (Molgradex®) compared to placebo leads to acute lung failure in fewer COVID-19 patients.