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A 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 Syndrome

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

Yokosawa Jun

Alexion Pharm GK

Ebisu First Square 1-18-14 Ebisu, Shibuya-Ku, Tokyo

Jun.Yokosawa@alexion.com

Yokosawa Jun

Alexion Pharm GK

Ebisu First Square 1-18-14 Ebisu, Shibuya-Ku, Tokyo

+81-3-5795-0775

Jun.Yokosawa@alexion.com

Suspended

Sept. 10, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

Both

COVID 19 severe pneumonia, acute lung injury, or ARDS

The ravulizumab will be administered via IV infusion as below dosage regimen;
In cae Patient Body Weight (kg) is 40 to 60, 2400mg at Day1, 600mg at at Day5 and Day10 and 900mg at Day15
In cae Patient Body Weight (kg) is 60 to 100, 2700mg at Day1, 900mg at at Day5, Day10 and Day15
In cae Patient Body Weight (kg) is over 100, 3000mg at Day1, 900mg at at Day5, Day10 and Day15

COVID-19

Survival (based on all-cause mortality) at Day 29

Number of days free of mechanical ventilation at Day 29
Duration of intensive care unit stay at Day 29
Change from baseline in SOFA score at Day 29
Change from baseline in SpO2/FiO2 at Day 29
Duration of hospitalization at Day 29
Survival (based on all-cause mortality) at Day 60 and Day 90

+81-3-5803-4575

June. 23, 2020

United States/United Kingdom/France/Spain