Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

COVID-19 Pulmonary Complications COVID-19 Corona Virus Infection Zanubrutinib Supportive Care

Eligibility

You can join if…

Open to people ages 18 years and up

  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

  1. Radiographic evidence of pulmonary infiltrates

You CAN'T join if...

  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.

Locations

  • UCLA Medical Center not yet accepting patients
    Sylmar California 91342 United States
  • St. Jude Medical Center accepting new patients
    Fullerton California 92835 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT04382586
Phase
Phase 2
Study Type
Interventional
Last Updated