Clinical Trial TitleA 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 ARDS
National Clinical Trial Number:NCT04369469
Clinical Trial Protocol Description:
The purpose of the study is 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 syndrome. Subjects s will be randomly assigned to receive ravulizumab in addition to best supportive care or best supportive care alone.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are a male or female ≥ 18 years of age and ≥ 40 kg at the time of providing informed consent.
- Have a confirmed diagnosis of SARS-CoV-2 infection (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization.
- Have severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography (CT) or X-ray at Screening or within the 3 days prior to Screening, as part of the patient's routine clinical care.
- Have respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]).
- Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.
You will be excluded from the study if any of the following criteria apply to you:
- Are not expected to survive for more than 24 hours.
- Are on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
- Have severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
- Have an unresolved Neisseria meningitidis infection.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.