CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Zanubrutinib +2 moredrug
Likely dose
Zanubrutinib 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04382586
NCT04382586Phase 2Completed
CompareCT.gov

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

BeiGene·interventional·Posted May 11, 2020·Updated Oct 26, 2024

In Brief

A Phase 2 clinical trial evaluating Zanubrutinib, Supportive Care, and 1 other intervention for COVID-19 Pulmonary Complications and COVID-19. Completed, enrolled 63 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19 Pulmonary Complications, COVID-19
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 11, 2020
Enrollment StartJul 6, 2020
Primary CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.1 years ago

Interventions

Zanubrutinibdrug

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

Supportive Caredrug

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

Placebodrug

Placebo to match zanubrutinib