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

BeiGene

Status and phase: Completed; Phase 2

Conditions: COVID-19 Pulmonary Complications; COVID-19

Treatments: Drug: Placebo; Drug: Zanubrutinib; Drug: Supportive Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04382586

BGB-3111-219

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups

Zanubrutinib + Supportive Care

Experimental group

Description:

Participants received zanubrutinib plus supportive care

Treatment:

Drug: Supportive Care

Drug: Zanubrutinib

Placebo + Supportive Care

Active Comparator group

Description:

Participants received placebo plus supportive care alone

Treatment:

Drug: Supportive Care

Drug: Placebo