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

NCT04382586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-10-26

Study results available
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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.

Conditions

  • COVID-19 Pulmonary Complications
  • COVID-19

Interventions

DRUG

Zanubrutinib

320 mg (4 x 80 mg) capsules administered orally once daily

DRUG

Supportive Care

Supportive care treatment was selected and administered as deemed appropriate by the study investigator

DRUG

Placebo

Placebo to match zanubrutinib

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2021-02-01
Completion
2021-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04382586 on ClinicalTrials.gov