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.
Drug: Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
Other Name: Array
Drug: Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Drug: Placebo
Placebo to match zanubrutinib
Key Inclusion Criteria:
1. Hospitalization for COVID-19 infection
2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
polymerase chain reaction (PCR)
3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19
infection, and has been on supplemental oxygen for no more than 96 hours from time of
screening
Key Exclusion Criteria:
1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel, symptomatic inflammatory bowel disease or
ulcerative colitis, or partial or complete bowel obstruction
2. On a Bruton's tyrosine kinase (BTK) inhibitor
3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20
monoclonal antibody treatment
4. Participants with prior of current hematologic malignancy or solid tumor malignancy
with treatment within 6 months prior to study entry
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Honor Health
Scottsdale, Arizona, United States
St. Jude Medical Center
Fullerton, California, United States
Olive View - UCLA Medical Center
Sylmar, California, United States
MedStar Heath Research Institute/ MedStar Washington Hospital Center
Washington, District of Columbia, United States
Augusta University
Augusta, Georgia, United States
John D. Archbold Memorial Hospital
Thomasville, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
SIU School of Medicine
Springfield, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham And Women's Hospital
Boston, Massachusetts, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers University Hospital
Newark, New Jersey, United States
Atlantic Health System, Inc. / Chilton Medical Center
Pompton Plains, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Therapeutic Concepts
Houston, Texas, United States
Covenant Health System
Lubbock, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Study Director, Principal Investigator
BeiGene