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

• Status: Completed
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Zanubrutinib

Criteria

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. Cohort 1: Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 48 hours. Cohort 2: Participants will have been on mechanical ventilation for ≤ 24 hours from the time of screening

4. Radiographic evidence of pulmonary infiltrates

Key Exclusion Criteria:

1. Participant is on mechanical ventilation for > 24 hours

2. 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

3. On a BTK inhibitor

4. Planned or concurrent use of tocilizumab

5. Participants with cancer

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.