NCT04382586
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
PHASE2
COMPLETED
NCT04382586
INTERVENTIONAL
A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress
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.
Key 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
Key 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
COVID-19 Pulmonary Complications
COVID-19
- TREATMENT
-
- Type: DRUG
- Name: Zanubrutinib
- Description: 320 mg (4 x 80 mg) capsules administered orally once daily
- Arm Group Labels: Zanubrutinib + Supportive Care
-
- Type: DRUG
- Name: Supportive Care
- Description: Supportive care treatment was selected and administered as deemed appropriate by the study investigator
- Arm Group Labels: Placebo + Supportive Care, Zanubrutinib + Supportive Care
-
- Type: DRUG
- Name: Placebo
- Description: Placebo to match zanubrutinib
- Arm Group Labels: Placebo + Supportive Care
- BeiGene