Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
1 other identifier
interventional
63
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2020
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2020
CompletedFirst Posted
Study publicly available on registry
May 11, 2020
CompletedStudy Start
First participant enrolled
July 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedResults Posted
Study results publicly available
March 2, 2022
CompletedOctober 26, 2024
October 1, 2024
7 months
May 7, 2020
January 31, 2022
October 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Up to 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.
Up to 7 months
Secondary Outcomes (9)
Number of Participants Experiencing Respiratory Failure or Death
Up to Day 28
Number of Participants With All-cause Mortality
Up to Day 28
Number of Participants Discharged Alive
Up to Day 28
Number of Participants Discharged Alive From the ICU
Up to Day 28
Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale
Up to Day 28
- +4 more secondary outcomes
Study Arms (2)
Zanubrutinib + Supportive Care
EXPERIMENTALParticipants received zanubrutinib plus supportive care
Placebo + Supportive Care
ACTIVE COMPARATORParticipants received placebo plus supportive care alone
Interventions
320 mg (4 x 80 mg) capsules administered orally once daily
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (10)
St Jude Medical Center
Fullerton, California, 92835, United States
Medstar Heath Research Institute Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
John D Archbold Memorial Hospital
Thomasville, Georgia, 31792, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
The Brigham and Womens Hospital, Inc
Boston, Massachusetts, 02115, United States
Rutgers University Hospital
Newark, New Jersey, 07103, United States
Therapeutics Concepts
Houston, Texas, 77004, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Treon SP, Kotton CN, Park DJ, Moranzoni G, Lemvigh CK, Gathe JC Jr, Varughese TA, Barnett CF, Belenchia JM, Clark NM, Farber CM, Abid MB, Ahmed G, Patterson CJ, Guerrera ML, Soumerai JD, Chea VA, Carulli IP, Southard J, Li S, Wu CJ, Livak KJ, Holmgren E, Kim P, Shi C, Lin H, Ramakrishnan V, Ou Y, Olszewski S, Olsen LR, Keskin DB, Hunter ZR, Tankersley C, Zimmerman T, Dhakal B. A randomized, placebo-controlled trial of the BTK inhibitor zanubrutinib in hospitalized patients with COVID-19 respiratory distress: immune biomarker and clinical findings. Front Immunol. 2025 Jan 21;15:1369619. doi: 10.3389/fimmu.2024.1369619. eCollection 2024.
PMID: 39906744DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- PRINCIPAL INVESTIGATOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2020
First Posted
May 11, 2020
Study Start
July 6, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
October 26, 2024
Results First Posted
March 2, 2022
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share