NCT04382586

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

Official Title:

A Phase 2, Randomized, Double Blind, Placebo-Controlled Study of Zanubrutinib Treatment in Patients Hospitalized for COVID-19 Infection and Pulmonary Distress

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 Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.

Eligibility

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.

Disease(s) and\or Condition(s)

COVID-19 Pulmonary Complications

COVID-19

Primary Purpose
  • TREATMENT
Intervention/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
Sponsor
  • BeiGene