Phase 3 Open-label Randomized Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia Acute Lung Injury or Acute Respiratory Distress

Brief description of study

ULTOMIRIS® (ravulizumab), an effective and widely studied terminal complement inhibitor with a well-established safety profile, is proposed for the treatment of patients who have a confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with a clinical presentation consistent with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome (ARDS). The use of ULTOMIRIS in this study is “investigational”. “Investigational” means that it is not approved by health authorities for treating severe pneumonia, ALI or ARDS associated with COVID- 19 infection. Treatment with ravulizumab could decrease COVID-19-induced lung injury. The purpose is to study the safety and efficacy of ravulizumab.


Clinical Study Identifier: s20-00680
ClinicalTrials.gov Identifier: NCT04369469
Principal Investigator: Howard Belmont.


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