Trial · NCT04382586

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

NCT04382586, Phase 2, Completed, BeiGene; results first posted 2022-03-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants. Trials, record NCT04382586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04382586

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants
NCT number: NCT04382586
Status: Completed
Phases: Phase 2
Enrollment: 63 participants, actual
Lead sponsor: BeiGene
Conditions: COVID-19 Pulmonary Complications, COVID-19
Interventions: Zanubrutinib, Supportive Care, Placebo
First posted: 2020-05-11
Last updated: 2024-10-26
Results first posted: 2022-03-02

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Respiratory Failure-free Survival	Up to Day 28	Number of participants with respiratory failure-free survival, defined as not having died or gone into respiratory failure on or before Day 28
Primary	Time to Breathing Room Air	Up to 7 months	Time to return to breathing room air is defined as the time from randomization date to the earliest time where the participant is stable on room air without supplemental oxygen. Total follow-up time in days is the total time of all participants from the randomization date to the first event date or Day 28 if there is no event. The rate was calculated as total number of events in which a participant returned to breathing room air on or before Day 28 divided by the total follow-up time in days.
Secondary	Number of Participants Experiencing Respiratory Failure or Death	Up to Day 28	Number of participants experiencing respiratory failure or death on or before Day 28
Secondary	Number of Participants With All-cause Mortality	Up to Day 28	Number of participants with all-cause mortality on or before Day 28
Secondary	Number of Participants Discharged Alive	Up to Day 28	Number of participants discharged alive on or before Day 28
Secondary	Number of Participants Discharged Alive From the ICU	Up to Day 28	Number of participants discharged alive from the intensive care unit (ICU) on or before Day 28
Secondary	Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale	Up to Day 28	Number of participants with improvement in WHO 8-point-scale, in which improvement was considered a score that changed from ≥4 at baseline to ≤ 3 at Day 28 as assessed by the investigator. Scoring ranges from 0 = uninfected with no clinical or virologic evidence of disease to 8 = dead.
Secondary	Duration of Mechanical Ventilation	Up to Day 28	Number of days on mechanical ventilation on or before Day 28
Secondary	Duration of Hospitalization	Up to Day 28	Number of days hospitalized on or before Day 28
Secondary	PaO2:FiO2 Ratio	Baseline, Day 7, Day 14, Day 21 and Day 28	Partial pressure of oxygen (PaO2):fraction of inspired oxygen (FiO2) ratio

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Respiratory Failure-free Survival	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Time to Breathing Room Air	Up to 7 months	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Events / total follow-up in days	NUMBER
SECONDARY	Number of Participants Experiencing Respiratory Failure or Death	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With All-cause Mortality	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Discharged Alive	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Discharged Alive From the ICU	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants; Here, overall number of participants analyzed represents participants who were admitted to the ICU and are evaluable for this outcome measure	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Mechanical Ventilation	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants, excluding participants who died before event completion; Here, overall number of participants analyzed represents participants who progressed from supplemental oxygen to mechanical ventilation and are evaluable for this outcome measure	Days	MEDIAN
SECONDARY	Duration of Hospitalization	Up to Day 28	The Intent-to-Treat (ITT) Analysis Set includes all randomized participants, excluding participants who died before event completion	Days	MEDIAN
SECONDARY	PaO2:FiO2 Ratio	Baseline, Day 7, Day 14, Day 21 and Day 28	The Intent-to-Treat Analysis Set included all randomized participants; Here, overall number of participants analyzed represents participants who progressed from supplemental oxygen to mechanical ventilation and are evaluable for this outcome measure and number analyzed represents participants with evaluable data at each time point	mmHg	MEDIAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With Respiratory Failure-free Survival	Zanubrutinib + Supportive Care	27	Participants
Number of Participants With Respiratory Failure-free Survival	Placebo + Supportive Care	28	Participants
Time to Breathing Room Air	Zanubrutinib + Supportive Care	0.060	Events / total follow-up in days
Time to Breathing Room Air	Placebo + Supportive Care	0.061	Events / total follow-up in days
Number of Participants Experiencing Respiratory Failure or Death	Zanubrutinib + Supportive Care	3	Participants
Number of Participants Experiencing Respiratory Failure or Death	Placebo + Supportive Care	5	Participants
Number of Participants With All-cause Mortality	Zanubrutinib + Supportive Care	2	Participants
Number of Participants With All-cause Mortality	Placebo + Supportive Care	4	Participants
Number of Participants Discharged Alive	Zanubrutinib + Supportive Care	26	Participants
Number of Participants Discharged Alive	Placebo + Supportive Care	28	Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zanubrutinib + Supportive Care	30
Overall Study	STARTED	Placebo + Supportive Care	33
Overall Study	COMPLETED	Zanubrutinib + Supportive Care	13
Overall Study	COMPLETED	Placebo + Supportive Care	17
Overall Study	NOT COMPLETED	Zanubrutinib + Supportive Care	17
Overall Study	NOT COMPLETED	Placebo + Supportive Care	16

Source ClinicalTrials.gov

Adverse events166

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Zanubrutinib + Supportive Care	1	30	1
other	Anaemia	Blood and lymphatic system disorders	Placebo + Supportive Care	1	29	1
other	Leukocytosis	Blood and lymphatic system disorders	Zanubrutinib + Supportive Care	1	30	1
other	Leukocytosis	Blood and lymphatic system disorders	Placebo + Supportive Care	0	29	0
other	Pancytopenia	Blood and lymphatic system disorders	Zanubrutinib + Supportive Care	1	30	1
other	Pancytopenia	Blood and lymphatic system disorders	Placebo + Supportive Care	0	29	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Zanubrutinib + Supportive Care	1	30	1
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo + Supportive Care	0	29	0
other	Atrial fibrillation	Cardiac disorders	Zanubrutinib + Supportive Care	0	30	0
other	Atrial fibrillation	Cardiac disorders	Placebo + Supportive Care	1	29	1

1 to 10 of 166Source ClinicalTrials.gov

See all 166 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zanubrutinib + Supportive Care	3	30
Total, all-cause mortality	Placebo + Supportive Care	4	33
Total, other adverse events	Zanubrutinib + Supportive Care	19	30
Total, other adverse events	Placebo + Supportive Care	20	29
Total, serious adverse events	Zanubrutinib + Supportive Care	4	30
Total, serious adverse events	Placebo + Supportive Care	7	29

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39906744	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants With Respiratory Failure-free Survival	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants With All-cause Mortality	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants With Improvement in the World Health Organization (WHO) 8-point Ordinal Scale	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants Discharged Alive	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants Experiencing Respiratory Failure or Death	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: Number of Participants Discharged Alive From the ICU	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: deaths from any cause	Trial comparisons
Zanubrutinib + Supportive Care vs Placebo + Supportive Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04382586

GET https://conductscience.org/api/trials/v1/NCT04382586/results?page=2

API reference For AI assistants