COVID-19 Clinical Trial
Official title:
Single-center, Prospective, Open-label, Comparator Study, Blind for Central Accessor to Access the Efficacy, Safety, and Tolerability of Inhalations of Low-doses of Melphalan in Patients With Pneumonia With Confirmed or Suspected COVID-19
This single-center, prospective, open-label, comparator study, blind for central accessor evaluates the efficacy, safety of inhalations of low-doses of melphalan in patients with pneumonia with confirmed or suspected COVID-19. All patients will receive 0,1 mg of melphalan in 7-10 daily inhalations 1 time per day.
It was previously shown that in ultra-low (more than 100 times lower than conventional
therapeutic) doses inhalations of alkylating drug (melphalan) are effective in severe
steroid-resistant bronchial asthma, a form of the disease often characterised by neutrophilic
type of inflammation. The exacerbation frequency reduced after the treatment, steroid-sparing
effect was shown, morphological signs of bronchial epithelial regeneration were revealed and
quality of life of asthmatic patients, treated with ultra-low doses of melphalan, improved.
In preclinical studies and studies with volunteers, it was found that inhalations of
ultra-low doses of melphalan do not have cytotoxic properties, but have local and systemic
anti-inflammatory effects and decrease the activation of lymphocytes due to blockade of heavy
β-chain of the interleukin (IL)-2 surface receptor. In addition, in ultra-low concentrations,
alkylating agents are able to disrupt the cell signalling through the receptor for tumor
necrosis factor (TNF), thereby exerting a protective effect from the cytotoxic activity of
TNF-α, which leads to the anti-inflammatory response.
Taking into account, that severe cases of COVID are characterised with hyperergic
inflammatory response (and in some cases even with the development of "cytokine storm") it
can be assumed that the inhalation use of low-doses of melphalan due to its anti-inflammatory
properties can be effective treatment for patients with COVID-associated pneumonia.
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