On Aug. 3, 2021, CytoDyn announced that Brazil’s regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved the previously submitted clinical trial protocol to commence patient enrollment in its CD17 trial for severe COVID-19 patients. The Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH) in Brazil conducted the trial.

The COVID-19 trial in Brazil was intended to provide ANVISA with the requisite data to consider advancing the availability of leronlimab to Brazilians infected with COVID-19. This Phase 3 trial was conducted in up to 35 clinical sites with 612 patients who are hospitalized and in need of oxygenation support. The trial aimed to prevent the disease from evolving into a more severe case, requiring invasive mechanical ventilation. Additionally, ANVISA was reviewing another protocol submitted for a second clinical trial for 316 critically ill COVID-19 patients.