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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Weight-based doses of ravulizumab were administered intravenously on Days 1, 5, 10, and 15.
Participants received medications, therapies, and interventions per standard hospital treatment protocols.
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
Survival (Based On All-Cause Mortality) in Participants in the ITT Population At Day 29
Survival (based on all-cause mortality) in Participants in the ITT Population at Day 29 was analyzed. The result for the survival was estimated survival combined over all imputations.
Time frame: Day 29
Number Of Days Free Of Mechanical Ventilation At Day 29
The number of days free of mechanical ventilation was defined as the total number of days from Day 1 to Day 29 without invasive or non-invasive mechanical ventilation.
Time frame: Day 29
Number of Days the Participants Were Alive and Not in ICU
The number of days that the participants were alive and not in the ICU from Day 1 through Day 29 are presented.
Time frame: Day 1 through Day 29
Change From Baseline In Sequential Organ Failure Assessment (SOFA) At Day 29
Baseline was defined as the last available assessment on or before Day 1 for all participants. Participants were evaluated using the SOFA score, an assessment tool that included a review of 6 organ systems: respiratory, renal, hepatic, cardiac, coagulation, and central nervous system. Each organ system was scored from 0 to 4 points using the worst value observed within the previous 24 hours. The total score ranged from 0 to 24, with a higher score indicating a worse condition.
Time frame: Baseline, Day 29
Change From Baseline In Peripheral Capillary Oxygen Saturation/Fraction Of Inspired Oxygen (SpO2/FiO2) At Day 29
Oxygenation was measured using the SpO2 and the amount of supplemental oxygen as measured by the FiO2 received by taking the ratio of these 2 measures at the same time point.
Time frame: Baseline, Day 29
Number of Days the Participants Were Alive and Not in the Hospital
The number of days that the participants were alive and not in the hospital from Day 1 through Day 29 are presented.
Time frame: Day 1 through Day 29
Estimated Number of Participants Alive At Up To Day 60 and At Up To Day 90
For this analysis, 2 participants in Group 1 (Ravulizumab + BSC) and 1 participant in Group 2 (BSC Alone) were censored at Day 90. The estimated number of participants alive for this analysis was calculated using the method of Kaplan and Meier (KM) and compared using a log-rank test stratified by intubated or not intubated on Day 1 as a sensitivity analysis. This Outcome Measure was designed to project an estimate of how many participants would be alive and not the actual number of alive participants. All-Cause Mortality data is provided in the Adverse Events Section.
Time frame: Up to Day 60 and Up to Day 90
Serum Ravulizumab Concentrations Prior to Dosing on Day 1 and Day 29
Results are reported in micrograms/milliliter (μg/mL).
Time frame: Day 1 and Day 29
Change From Baseline In Serum Free Complement Component 5 Concentrations At Day 29
Time frame: Baseline, Day 29
Change From Baseline In Terminal Complement Complex C5b-9 At Day 29
Time frame: Baseline, Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 29 more locations