COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2031200126

Jun Yokosawa

Jun.Yokosawa@alexion.com

2020-09-23

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1.Males or females over or equal 18 years of age and over or equal 40 kg at the time of providing informed consent2.Confirmed diagnosis of SARS-CoV-2 infection presenting as severe COVID-19 requiring hospitalization3.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 care4.Severe pneumonia, acute lung injury, or acute respiratory distress syndrome requiring oxygen supplementation with invasive or noninvasive mechanical ventilation5.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 hoursPatient is on invasive mechanical ventilation with intubation for more than 48 hours prior to ScreeningSevere 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 infectionUse 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

4

Yokosawa Jun

18

100

France;Japan;Spain;United Kingdom;United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

270

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

Phase 3

[{"arm_notes": "", "treatment_id": 1065, "treatment_name": "Ravulizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1065, "treatment_name": "Ravulizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1065, "treatment_name": "Ravulizumab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]