Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia

Stopped early · Phase 3

Conditions studied: COVID-19 Severe Pneumonia, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Viral

In brief

This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

Key facts

Study ID

NCT04369469

Run by

Alexion Pharmaceuticals, Inc.

People needed

202

Starts

2020-05-10

Expected to finish

2021-04-08

Last updated by the study team

2022-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or female participants ≥ 18 years of age and ≥ 40 kilograms at the time of providing informed consent.
• Confirmed diagnosis of severe acute respiratory syndrome coronavirus 2 infection (for example, via polymerase chain reaction and/or antibody test) presenting as severe COVID-19 requiring hospitalization.
• Severe pneumonia, acute lung injury, or acute respiratory distress syndrome confirmed by computed tomography or X-ray at Screening or within the 3 days prior to Screening, as part of the participant's routine clinical care.
• Respiratory distress requiring mechanical ventilation, which can be either invasive (requiring endotracheal intubation) or noninvasive (with continuous positive airway pressure or bilevel positive airway pressure).
• Female participants of childbearing potential and male participants with female partners of childbearing potential must follow protocol specified contraception guidance for avoiding pregnancy for 8 months after treatment with the study drug.

You may not qualify if…

• Participant was not expected to survive for more than 24 hours.
• Participant was on invasive mechanical ventilation with intubation for more than 48 hours prior to Screening.
• Severe pre-existing cardiac disease (that is, New York Heart Association Class 3 or Class 4, acute coronary syndrome or persistent ventricular tachyarrhythmias).
• Participant had an unresolved Neisseria meningitidis infection.
• Used the following medications and therapies:
• Current treatment with a complement inhibitor or
• Intravenous immunoglobulin within 4 weeks prior to randomization on Day 1
• Treatment with investigational therapy in a clinical study within 30 days before randomization, or within 5 half-lives of that investigational therapy, whichever was greater. Exceptions:
• Investigational therapies were allowed if received as part of BSC through an expanded access protocol or emergency approval for the treatment of COVID-19.
• Investigational antiviral therapies (such as remdesivir) were allowed even if received as part of a clinical study.
• Female participants who were breastfeeding or who have a positive pregnancy test result at Screening.
• History of hypersensitivity to any ingredient contained in the study drug, including hypersensitivity to murine proteins.
• Participant who was not currently vaccinated against Neisseria meningitidis, unless the participant 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 participant receives vaccination against Neisseria meningitidis.

Where it is running

• Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
• LAC/USC Health Center — Los Angeles, California, United States
• UC Irvine Medical Center — Orange, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• University of Florida — Jacksonville, Florida, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Baltimore VA Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Health System — Mankato, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• NYU Langone Health Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Mayo Clinic Health System in Eau Claire — Eau Claire, Wisconsin, United States
• Mayo Clinic Health System — La Crosse, Wisconsin, United States
• Hôpital Raymond Poincaré — Garches, Hauts De Seine, France

Full record on ClinicalTrials.gov

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