COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome MedDRA version: 20.0 Level: PT Classification code 10061229 Term: Lung infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ravulizumab
Current Sponsor code: ALXN1210
Other
Sponsors
Alexion Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To characterize the overall safety of ravulizumab + BSC compared with BSC alone in patients with COVID-19 To characterize the PK/PD and immunogenicity of ravulizumab in patients with COVID-19 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 - Duration of hospitalization at day 29 -Change from baseline in SpO2/FiO2 at Day 29 - Survival (based on all-cause mortality) at Day 60 and Day 90;Timepoint(s) of evaluation of this end point: Day 29 Day 60 and Day 90 (survival only) | — |
Countries
France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactEuropean Clinical Trial Information
Alexion Europe SAS
Outcome results
None listed