Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
NCT ID: NCT04382586
Last Updated: 2024-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2020-07-06
2021-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pyridostigmine in Severe SARS-CoV-2 Infection
NCT04343963
A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19
NCT04380961
SLV213 Treatment in Ambulatory COVID-19 Patients
NCT04843787
Safety, Tolerability and Efficacy of S-1226 in Post-COVID-19 Subjects With Persistent Respiratory Symptoms.
NCT04949386
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
NCT04569227
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zanubrutinib + Supportive Care
Participants received zanubrutinib plus supportive care
Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Placebo + Supportive Care
Participants received placebo plus supportive care alone
Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Placebo
Placebo to match zanubrutinib
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zanubrutinib
320 mg (4 x 80 mg) capsules administered orally once daily
Supportive Care
Supportive care treatment was selected and administered as deemed appropriate by the study investigator
Placebo
Placebo to match zanubrutinib
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BeiGene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: PRINCIPAL_INVESTIGATOR
BeiGene
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Jude Medical Center
Fullerton, California, United States
Medstar Heath Research Institute Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
John D Archbold Memorial Hospital
Thomasville, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Brigham and Womens Hospital, Inc
Boston, Massachusetts, United States
Rutgers University Hospital
Newark, New Jersey, United States
Therapeutics Concepts
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BGB-3111-219
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.