Purpose

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult patients with Coronavirus Disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Patients will be randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the patients) or BSC alone (1/3 of the patients). Best supportive care will consist of medical treatment and/or medical interventions per routine hospital practice.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 (eg, via polymerase chain reaction [PCR] and/or antibody test) presenting as severe COVID-19 requiring hospitalization 3. 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 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

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: - Current treatment with a complement inhibitor or - 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: - 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 - 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ravulizumab plus Best Supportive Care
  • Biological: Ravulizumab
    Weight-based doses of ravulizumab will be administered intravenously on Days 1, 5, 10, and 15.
    Other names:
    • Ultomiris
    • ALXN1210
  • Other: Best Supportive Care
    Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.
Other
Best Supportive Care
  • Biological: Ravulizumab
    Weight-based doses of ravulizumab will be administered intravenously on Days 1, 5, 10, and 15.
    Other names:
    • Ultomiris
    • ALXN1210
  • Other: Best Supportive Care
    Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.

Recruiting Locations

MedStar Georgetown University Hospital
Washington, District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Alexion Pharmaceuticals

Study Contact

Alexion Pharmaceuticals, Inc.
+1 855-752-2356
clinicaltrials@alexion.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.