ravulizumab for the treatment of patients with Coronavirus Disease 2019
- Conditions
- COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndromeMedDRA version: 20.0Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001497-30-DE
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 270
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of ravulizumab + Best Supportive Care (BSC) compared with BSC alone on the survival of patients with COVID-19;Secondary Objective: To evaluate the efficacy of ravulizumab + BSC compared with BSC alone on outcomes in patients with COVID-19<br>To characterize the overall safety of ravulizumab + BSC compared with BSC alone in patients with COVID-19<br>To characterize the PK/PD and immunogenicity of ravulizumab in patients with COVID-19<br>To assess the effect of C5 inhibition on systemic activation of complement and inflammation in patients with COVID-19;Primary end point(s): Survival;Timepoint(s) of evaluation of this end point: Day 29
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Number of days free of mechanical ventilation<br>- Change from baseline in SpO2/FiO2<br>- Duration of intensive care unit stay<br>- Change from baseline in SOFA score<br>- Duration of hospitalization<br>- Survival;Timepoint(s) of evaluation of this end point: Day 29<br>Day 60 and Day 90 (survival only)