ravulizumab for the treatment of patients with Coronavirus Disease 2019

Phase 1

• Conditions: COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome; MedDRA version: 20.0Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001497-30-FR
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-28
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Males or females = 18 years of age and = 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 ARDS 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 ARDS 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Patient is not expected to survive for more than 24 hours.
2. Patient is on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
3. Severe pre-existing cardiac disease (ie, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
4. Patient has an unresolved Neisseria meningitidis infection.
5. Use of the following medications and therapies:
a. Current treatment with a complement inhibitor,
b. Rituximab within 3 months of Screening,
c. Mitoxantrone within 3 months of Screening, and
d. Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening.
6. 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.
7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening or on Day 1.
8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified