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Alexion Pharmaceuticals intends to assess its blood disorder drug Ultomiris (ravulizumab-cwvz) to treat adult Covid-19 patients hospitalised with severe pneumonia or acute respiratory distress syndrome (ARDS).
The US Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for the drug in severe Covid-19 indication.
Ultomiris is a long-acting C5 complement inhibitor. The biologic medicine has approvals to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and complement-mediated thrombotic microangiopathy.
The new trial is designed to assess the drug’s effect on survival, mechanical ventilation duration, and hospital stay when compared to best supportive care.
Starting in May, the open-label, randomised, controlled study is set to recruit around 270 patients in countries with high Covid-19 cases.
The primary endpoint is survival at day 29, while secondary endpoints include the need for mechanical ventilation, oxygenation, ICU stay and hospitalisation duration, and safety.
A four-week treatment period will be followed by safety monitoring for three months.
Alexion Pharmaceuticals Research & Development executive vice-president and head John Orloff said: “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.
“As we move quickly to initiate this programme, we also remain committed to serving the patients who currently rely on our medicines and providing continuous supply to these patients.”
The company noted that independent investigators are interested in assessing the potential of C5 inhibition for severe Covid-19 pneumonia.
While several independent studies are ongoing, Alexion believes that a controlled clinical programme is necessary to determine C5 inhibition’s impact with Ultomiris.