ravulizumab for the treatment of patients with Coronavirus Disease 2019

Phase 1

Active, not recruiting

• Conditions: COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome; MedDRA version: 22.1Level: LLTClassification code 10061229Term: Lung infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001497-30-IT
• Lead Sponsor: ALEXION PHARMACEUTICALS INCORPORATED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-12
• Study Completion: 2021-04-08
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 202

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. Respiratory Distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]).
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. Intravenous immunoglobulin (IVIg) within 4 weeks prior to randomization on Day 1.
6.Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half -lives of that investigational therapy, whichever is greater
Exceptions:
a.Investigational therapies will be allowed if received as part of best supportive care through an expanded access protocol or emergency approval for the treatment of COVID 19.
b.Investigational antiviral therapies (such as remdesivir) will be allowed even if received as part of a clinical study.
7. Female patients who are breastfeeding or who have a positive pregnancy test result at Screening.
8. History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
9.Patient who is not currently vaccinated against N. meningitidis, unless the patient agrees to receive prophylactic treatment with appropriate antibiotics for at least 8 months after the last infusion of study drug or until at least 2 weeks after the patient receives vaccination against N. meningitidis.

Study & Design

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