Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
  • Drug: Zanubrutinib
    320 mg (4 x 80 mg) capsules administered orally once daily
    Other names:
    • BGB-3111
    • Brukinsa
  • Drug: Supportive Care
    Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Active Comparator
Placebo + Supportive Care
Participants received placebo plus supportive care alone
  • Drug: Supportive Care
    Supportive care treatment was selected and administered as deemed appropriate by the study investigator
  • Drug: Placebo
    Placebo to match zanubrutinib

More Details

Status
Completed
Sponsor
BeiGene

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.