Official Title
A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
Brief Summary

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.

Completed
COVID-19 Pulmonary Complications
COVID-19

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

NCT Number
Keywords
Corona Virus
Covid-19
MeSH Terms
COVID-19
Zanubrutinib