Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host

Infectious diseases of respiratory system (COVID-19)

Percentage of patients with treatment-related AEs of grade ≥3 within 28 days and 90 days after the start of therapy, Percentage of patients with AEs (of any grade and those with serious conditions) of any grade and regardless of causality within 28 days and 90 days after the start of therapy

Percentage of patients who decide to discontinue therapy before day 10 or discharge, Difference between number of tablets taken and expected number of cysteamine tablets, Pharmacokinetic curve of cysteamine at day 7±1 (blood draws at 0, 1, 2 and 3 hours after drug administration), Cytokines and blood biomarkers at baseline and days 3, 7±1 (or hospital discharge if before day 10), 28±3., Modulation of gene expression induced by cysteamine therapy at day 7±1 compared with baseline, Number of days required for SARS-COV-2 swab negativization., Clinical status expressed by the 11 items of the WHO Clinical Progression Scale at day 7, 10 and 28., Number of days to hospital discharge

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