Purpose

The primary objective of this study is 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.

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. Cohort 1: Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 48 hours. Cohort 2: Participants will have been on mechanical ventilation for ≤ 24 hours from the time of screening
  4. Radiographic evidence of pulmonary infiltrates

Exclusion Criteria

  1. Participant is on mechanical ventilation for > 24 hours
  2. 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
  3. On a BTK inhibitor
  4. Planned or concurrent use of tocilizumab
  5. Participants with cancer

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
Cohort 1: Zanubrutinib + Supportive Care
Participants not requiring mechanical ventilation (Cohort 1) will receive 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 is selected and administered as deemed appropriate by the study investigator.
Active Comparator
Cohort 1: Placebo + Supportive Care
Participants not requiring mechanical ventilation (Cohort 1) will receive placebo plus supportive care alone
  • Drug: Supportive Care
    Supportive care treatment is selected and administered as deemed appropriate by the study investigator.
  • Drug: Placebo
    Placebo to match zanubrutinib
Experimental
Cohort 2: Zanubrutinib+Supportive Care
Participants who have been on mechanical ventilation for ≤ 24 hours (Cohort 2) will receive zanubrutinib plus supportive care alone for respiratory distress due to COVID-19 infection for up to 28 days
  • Drug: Zanubrutinib
    320 mg (4 x 80 mg) capsules administered orally once daily.
    Other names:
    • BGB-3111
    • Brukinsa
  • Drug: Supportive Care
    Supportive care treatment is selected and administered as deemed appropriate by the study investigator.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
BeiGene

Study Contact

BeiGene
+1-877-828-5568
clinicaltrials@beigene.com

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.