A phase 3 study evaluating Ultomiris (ravulizumab-cwvz; Alexion) in hospitalized patients with coronavirus disease 2019 (COVID-19) is expected to begin in May.
The Food and Drug Administration recently accepted Alexion’s investigational new drug (IND) application for Ultmoiris for severe COVID-19. Ravulizumab-cwvz works by inhibiting the C5 protein in the terminal complement cascade. Some preclinical data suggest that inhibition of terminal complement can lower cytokine and chemokine levels and significantly reduce lung inflammation in animal models of viral pneumonia.
The open-label, randomized, controlled study will include approximately 270 adult patients hospitalized with COVID-19 and severe pneumonia, acute lung injury or acute respiratory distress syndrome. Patients will be randomized 2:1 to receive ravulizumab-cwvz or best supportive care. In the treatment arm, patients will receive a weight-based loading dose of ravulizumab-cwvz on Day 1, with follow-up dosing on Days 5, 10 and 15. All patients will also continue to receive standard hospital treatment protocols for the duration of the study.
The primary end point of the study will be survival at day 29. Secondary end points will assess the need for mechanical ventilation, oxygenation, duration of ICU stay and hospitalization, and safety, among others.
“Based on early anecdotal information available from compassionate use cases in multiple countries, we are launching a controlled clinical trial to evaluate the potential of Ultomiris in mitigating the severe pneumonia and lung injury caused by the virus,” said John Orloff, MD, EVP and head of research and development at Alexion.
Ultomiris is currently approved as a treatment for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy.
For more information visit alexion.com.