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

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.