Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
Purpose
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.
Conditions
- COVID-19 Pulmonary Complications
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Zanubrutinib + Supportive Care |
Participants received zanubrutinib plus supportive care |
|
Active Comparator Placebo + Supportive Care |
Participants received placebo plus supportive care alone |
|
Recruiting Locations
More Details
- NCT ID
- NCT04382586
- Status
- Completed
- Sponsor
- BeiGene