Back to resultsCovid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Primary Purpose
COVID-19 Pulmonary Complications, COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zanubrutinib
Supportive Care
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Pulmonary Complications focused on measuring Corona Virus, COVID-19
Eligibility Criteria
Key Inclusion Criteria:
- Hospitalization for COVID-19 infection
- Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
- 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:
- 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
- On a Bruton's tyrosine kinase (BTK) inhibitor
- Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
- 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.
Sites / Locations
- Honor Health
- St. Jude Medical Center
- Olive View - UCLA Medical Center
- MedStar Heath Research Institute/ MedStar Washington Hospital Center
- Augusta University
- John D. Archbold Memorial Hospital
- Loyola University Medical Center
- SIU School of Medicine
- University of Iowa
- Massachusetts General Hospital
- Brigham And Women's Hospital
- Morristown Medical Center
- Rutgers University Hospital
- Atlantic Health System, Inc. / Chilton Medical Center
- Overlook Medical Center
- Therapeutic Concepts
- Covenant Health System
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zanubrutinib + Supportive Care
Placebo + Supportive Care
Arm Description
Participants received zanubrutinib plus supportive care
Participants received placebo plus supportive care alone
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
Number of Participants Experiencing Respiratory Failure or Death
Number of participants experiencing respiratory failure or death on or before Day 28
Number of Participants With All-cause Mortality
Number of participants with all-cause mortality on or before Day 28
Number of Participants Discharged Alive
Number of participants discharged alive on or before 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
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
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.
Duration of Mechanical Ventilation
Number of days on mechanical ventilation on or before Day 28
Duration of Hospitalization
Number of days hospitalized on or before Day 28
PaO2:FiO2 Ratio
Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04382586
Brief Title
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Official Title
A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pulmonary Complications, COVID-19
Keywords
Corona Virus, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zanubrutinib + Supportive Care
Arm Type
Experimental
Arm Description
Participants received zanubrutinib plus supportive care
Arm Title
Placebo + Supportive Care
Arm Type
Active Comparator
Arm Description
Participants received placebo plus supportive care alone
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111, Brukinsa
Intervention Description
320 mg (4 x 80 mg) capsules administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Supportive Care
Intervention Description
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match zanubrutinib
Primary Outcome Measure Information:
Title
Number of Participants With Respiratory Failure-free Survival
Description
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
Title
Time to Breathing Room Air
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Respiratory Failure or Death
Description
Number of participants experiencing respiratory failure or death on or before Day 28
Time Frame
Up to Day 28
Title
Number of Participants With All-cause Mortality
Description
Number of participants with all-cause mortality on or before Day 28
Time Frame
Up to Day 28
Title
Number of Participants Discharged Alive
Description
Number of participants discharged alive on or before Day 28
Time Frame
Up to Day 28
Title
Number of Participants Discharged Alive From the ICU
Description
Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Time Frame
Up to Day 28
Title
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
Description
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
Title
Duration of Mechanical Ventilation
Description
Number of days on mechanical ventilation on or before Day 28
Time Frame
Up to Day 28
Title
Duration of Hospitalization
Description
Number of days hospitalized on or before Day 28
Time Frame
Up to Day 28
Title
PaO2:FiO2 Ratio
Description
Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio
Time Frame
Baseline, Day 7, Day 14, Day 21 and Day 28
Title
Number of Participants With Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Hospitalization for COVID-19 infection
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
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:
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
On a Bruton's tyrosine kinase (BTK) inhibitor
Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
St. Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
MedStar Heath Research Institute/ MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
John D. Archbold Memorial Hospital
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
SIU School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62629
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham And Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Atlantic Health System, Inc. / Chilton Medical Center
City
Pompton Plains
State/Province
New Jersey
ZIP/Postal Code
07444
Country
United States
Facility Name
Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Therapeutic Concepts
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Covenant Health System
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79140
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
We'll reach out to this number within 24 hrs