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Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04382586•BeiGene

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (10)

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

Key Dates

Start Date

July 6, 2020

Primary Completion Date

February 1, 2021

Completion Date

February 1, 2021

Last Updated

October 26, 2024

Enrollment

ACTUAL participants

Conditions

COVID-19 Pulmonary ComplicationsCOVID-19

Interventions

Zanubrutinib

DRUG

Supportive Care

DRUG

Placebo

DRUG

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COVID-19

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

Inclusion Criteria

Exclusion Criteria

A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes

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