The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
320 mg (4 x 80 mg) capsules administered orally once daily
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Placebo to match zanubrutinib
St Jude Medical Center
Fullerton, California, United States
Medstar Heath Research Institute Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
John D Archbold Memorial Hospital
Thomasville, Georgia, United States
Number of Participants With Respiratory Failure-free Survival
Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
Time frame: Up to Day 28
Time to Breathing Room Air
Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
Time frame: Up to 7 months
Number of Participants Experiencing Respiratory Failure or Death
Number of participants experiencing respiratory failure or death on or before Day 28
Time frame: Up to Day 28
Number of Participants With All-cause Mortality
Number of participants with all-cause mortality on or before Day 28
Time frame: Up to Day 28
Number of Participants Discharged Alive
Number of participants discharged alive on or before Day 28
Time frame: Up to Day 28
Number of Participants Discharged Alive From the ICU
Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Time frame: Up to Day 28
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
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Loyola University Medical Center
Maywood, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Brigham and Womens Hospital, Inc
Boston, Massachusetts, United States
Rutgers University Hospital
Newark, New Jersey, United States
Therapeutics Concepts
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.
Time frame: Up to Day 28
Duration of Mechanical Ventilation
Number of days on mechanical ventilation on or before Day 28
Time frame: Up to Day 28
Duration of Hospitalization
Number of days hospitalized on or before Day 28
Time frame: Up to Day 28
PaO2:FiO2 Ratio
Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Time frame: Baseline, Day 7, Day 14, Day 21 and Day 28
Number of Participants With Adverse Events
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), treatment-related adverse events (AEs), and TEAEs grade 3 or higher, including laboratory findings
Time frame: Up to 7 months