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SilCOVID19 clinical trial: silibinin to prevent respiratory failure caused by SARS-CoV-2 infection
Silibinin is a natural molecule that has shown antiviral activity against different viruses. Silibinin has a pharmacological behaviour against SARS-CoV-2 RNA polymerase, and inhibits the activated STAT3 protein, a transcription factor that regulates acute respiratory distress syndrome (ARDS). We aim, through a clinical trial, to explore the efficacy of silibinin in preventing ARDS associated with COVID19 in onco-haematological patients.
The study will focus on onco-hematological patients, which are a high risk mortality population by COVID19. The study consists of a first phase, safety cohort (n = 10). The second phase is randomized with both arms (experimental and control, n = 41 per arm). The objective of the phase II is to determine the efficacy of the administration of silibinin, in addition the treatment of the protocol of the center of the researcher, in the early reduction of the inflammatory response caused by the infection of SARS-COV2 and the development of the acute respiratory distress syndrome (ARDS) after 14 days of treatment in comparation with the control arm.