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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200126

Enrollment

270

Registered

2020-09-23

Start date

2020-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19 severe pneumonia, acute lung injury, or ARDS COVID-19

Interventions

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 Day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Survival (based on all-cause mortality) at Day 29	—

Secondary

Measure	Time frame
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	—

Countries

France, Japan, Spain, United Kingdom, United States

Contacts

Public ContactJun Yokosawa

Alexion Pharm GK

Jun.Yokosawa@alexion.com+81-3-5795-0775

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026