ANVISA authorizes Dompé's REPAVID-19, a Phase II COVID-19 trial
Brazil's health regulatory agency, ANVISA, has greenlighted privately-held Italian biopharma company Dompé's REPAVID-19, a clinical trial of reparixin for treatment of severe COVID-19 patients.
Reparixin inhibits the action of interleukin 8 (IL-8), one of the inflammatory signaling proteins that is thought to be associated with the lung injury seen in patients with SARS-CoV2 infection. Consequently, this action is aimed to be useful in the treatment of COVID-19 pneumonia patients. The treatment is based on reparixin oral tablets 1200mg TID till 21 days, in case of confirmed improvement after seven days.
REPAVID-19 will enroll 48 for Phase II, 111 for Phase III with severe COVID-19 pneumonia randomized 2:1 in the Phase II, and the results will inform the study design for the Phase III. The study involves a minimum of 10 Brazilian centers.
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