A Phase 3 Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome
- Conditions
- COVID 19 severe pneumonia, acute lung injury, or ARDSCOVID-19
- Registration Number
- JPRN-jRCT2031200126
- Lead Sponsor
- Yokosawa Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 270
1.Males or females over or equal 18 years of age and over or equal 40 kg at the time of providing informed consent
2.Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization
3.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
4.Severe pneumonia, acute lung injury, or acute respiratory distress syndrome requiring oxygen supplementation with invasive or noninvasive mechanical ventilation
5.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
Patient is not expected to survive for more than 24 hours
Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening
Severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias)
Patient has an unresolved Neisseria meningitidis infection
Use of the following medications and therapies: Current treatment with a complement inhibitor and Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization.
Participation in another interventional treatment study within 30 days before initiation of ravulizumab on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.
History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival (based on all-cause mortality) at Day 29
- Secondary Outcome Measures
Name Time Method umber of days free of mechanical ventilation at Day 29<br>Duration of intensive care unit stay at Day 29<br>Change from baseline in SOFA score at Day 29<br>Change from baseline in SpO2/FiO2 at Day 29<br>Duration of hospitalization at Day 29<br>Survival (based on all-cause mortality) at Day 60 and Day 90