Status:
COMPLETED
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Lead Sponsor:
BeiGene
Conditions:
COVID-19 Pulmonary Complications
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 C...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04382586
Start Date
July 6 2020
End Date
February 1 2021
Last Update
October 26 2024
Active Locations (10)
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1
St Jude Medical Center
Fullerton, California, United States, 92835
2
Medstar Heath Research Institute Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
John D Archbold Memorial Hospital
Thomasville, Georgia, United States, 31792
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153