Status:
TERMINATED
Efficacy and Safety Study of IV Ravulizumab in Patients With COVID-19 Severe Pneumonia
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
COVID-19 Severe Pneumonia
Acute Lung Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lun...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2021
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04369469
Start Date
May 10 2020
End Date
April 8 2021
Last Update
May 24 2022
Active Locations (39)
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1
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
2
LAC/USC Health Center
Los Angeles, California, United States, 90033
3
UC Irvine Medical Center
Orange, California, United States, 92868
4
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007