Trial · NCT04375397

Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury

NCT04375397, Phase 2, Completed, AbbVie; results first posted 2022-06-01

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury. Trials, record NCT04375397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04375397

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Trial

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

Title: Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Pulmonary Injury
NCT number: NCT04375397
Status: Completed
Phases: Phase 2
Enrollment: 46 participants, actual
Lead sponsor: AbbVie
Conditions: CoronaVirus Induced Disease-2019 (COVID-19)
Interventions: Ibrutinib, Placebo
First posted: 2020-05-05
Last updated: 2022-06-01
Results first posted: 2022-06-01

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Alive and Without Respiratory Failure Through Day 28	Through Day 28	Respiratory failure is defined as a clinical diagnosis of respiratory failure and initiation of one of the following therapies: endotracheal intubation and mechanical ventilation; OR extracorporeal membrane oxygenation; OR high-flow nasal cannula oxygen delivery (i.e., reinforced nasal cannula delivering heated, humidified oxygen with fraction of delivered oxygen ≥ 0.5 and flow rates of ≥ 30 L/min); OR non-invasive positive pressure ventilation; OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation.
Secondary	Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	At Day 14	The WHO-8 is an ordinal scale for clinical improvement with scores ranging from 0 to 8, where a lower score indicates better clinical status. A score of 0 represents uninfected; 1 (ambulatory, no limitation of activities); 2 (ambulatory, limitation of activities); 3 (hospitalized with mild disease, no oxygen therapy); 4 (hospitalized with mild disease, oxygen by mask or nasal prongs); 5 (hospitalized with severe disease, non-invasive ventilation or high-flow oxygen); 6 (hospitalized with severe disease, intubation and mechanical ventilation); 7 (hospitalized with severe disease, ventilation and additional organ support \[pressors, renal replacement therapy, extracorporeal membrane oxygenation\]); and 8 (death). Negative values indicate improvement from baseline.
Secondary	Median Reduction in Days Spent on Supplemental Oxygen	Up to Day 28	Days spent on supplemental oxygen was set as the date of the participant being off of supplemental oxygen minus the date of initiation of supplemental oxygen + 1 day. If a participant received more than 1 period of supplemental oxygen therapy during the study or switched from supplemental oxygen to a more intensive therapy, then the days spent on supplemental oxygen were to be calculated as the sum of all the periods where the participant was on supplemental oxygen or a more intensive therapy through Day 28. If the date of the first initiation of supplemental oxygen was before Baseline Day 1, then the days spent on supplemental oxygen were to be calculated from Baseline Day 1 to the date of the participant being off the supplemental oxygen. Time on supplemental oxygen was to be imputed to the maximum number of days on study drug (28) for all points following the death of a participant.
Secondary	All-Cause Mortality at Study Days 7, 14, 21, and 28	At Study Days 7, 14, 21, and 28	The percentage of participants with mortality from any cause was recorded.
Secondary	Percentage of Participants Experiencing Respiratory Failure or Death on Study Days 7, 14, 21, and 28	At Study Days 7, 14, 21, and 28	Respiratory failure is defined as a clinical diagnosis of respiratory failure and initiation of one of the following therapies: endotracheal intubation and mechanical ventilation; OR extracorporeal membrane oxygenation; OR high-flow nasal cannula oxygen delivery (i.e., reinforced nasal cannula delivering heated, humidified oxygen with fraction of delivered oxygen ≥ 0.5 and flow rates of ≥ 30 L/min), OR non-invasive positive pressure ventilation; OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making is driven solely by resource limitation.
Secondary	Mechanical Ventilation-Free Survival	Up to Day 28	Mechanical ventilation-free survival is defined as the number of days from Baseline Day 1 to the date when a participant initiated mechanical ventilation or died, whichever occurred first, during the 28 days post baseline. If the specified event did not occur by Day 28, participants were to be censored. Specifically, a participant without any post-baseline assessment record was to be censored at Baseline Day 1, a participant who prematurely discontinued from study without a record of death or start of mechanical ventilation was to be censored at the earlier timepoint of the date of study discontinuation or Day 28, an ongoing participant in the study without a record of death or start of mechanical ventilation was to be censored at the earlier timepoint of the date of the last evidence that the participant is not on mechanical ventilation or Day 28.
Secondary	Days on Mechanical Ventilation	Up to Day 28	Days spent on mechanical ventilation was defined as the date of the participant being off mechanical ventilation - date of initiation of mechanical ventilation + 1 day. If a participant received more than 1 period of mechanical ventilation during the study or switched from mechanical ventilation to a more intensive therapy, then the days spent on mechanical ventilation were to be calculated as the sum of all the periods where the participant is on mechanical ventilation or a more intensive therapy through Day 28.
Secondary	Median Duration of Hospitalization	Up to Day 28	Median duration of hospitalization is defined as the hospitalization discharge date - hospitalization admission date + 1 day. If a participant was hospitalized more than once during the study then the hospitalization time was to be calculated as the sum of all the periods when the participant was hospitalized through Day 28.
Secondary	Time to Discharge From Hospital	Up to Day 28	Time to discharge from hospital is defined as the number of days from Baseline Day 1 to the date of the last evidence that a participant is last discharged from hospital, during the 28 days post baseline. If the specified event did not occur by Day 28, participants were censored. Specifically, a participant without any postbaseline assessment record was to be censored at Baseline Day 1, a participant who died was to have time to discharge from hospital censored at Day 28, a participant who prematurely discontinued from study without a record of hospitalization discharge was to be censored at the earlier timepoint of the date of study discontinuation or Day 28, an on-going participant in the study without a record of hospitalization discharge was to be censored at the earlier timepoint of the date of the last evidence that the participant is hospitalized or Day 28.
Secondary	Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio	At Study Days 7, 14, 21, and 28	The PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2). A PaO2/FiO2 ratio of 300 to 200 is mild, 200 to 100 moderate, and \<100 is severe Adult Respiratory Distress Syndrome (ARDS).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Alive and Without Respiratory Failure Through Day 28	Through Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	percentage of participants	NUMBER
SECONDARY	Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	At Day 14	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug; participants with baseline and Day 14 score data	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Reduction in Days Spent on Supplemental Oxygen	Up to Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	days	MEDIAN
SECONDARY	All-Cause Mortality at Study Days 7, 14, 21, and 28	At Study Days 7, 14, 21, and 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Experiencing Respiratory Failure or Death on Study Days 7, 14, 21, and 28	At Study Days 7, 14, 21, and 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	percentage of participants	NUMBER
SECONDARY	Mechanical Ventilation-Free Survival	Up to Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	days	MEDIAN
SECONDARY	Days on Mechanical Ventilation	Up to Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	days	MEDIAN
SECONDARY	Median Duration of Hospitalization	Up to Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	days	MEDIAN
SECONDARY	Time to Discharge From Hospital	Up to Day 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug	days	MEDIAN
SECONDARY	Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio	At Study Days 7, 14, 21, and 28	Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug. Participants with non-missing baseline and at least one post-baseline value are included in the analyses.	mmHg	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group53

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Alive and Without Respiratory Failure Through Day 28	Ibrutinib 420 mg + SOC		86.4	80% Confidence Interval 74.4 to 93.2	percentage of participants
Percentage of Participants Alive and Without Respiratory Failure Through Day 28	Placebo + SOC		79.2	80% Confidence Interval 66.9 to 87.7	percentage of participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Ibrutinib 420 mg + SOC	-4 points	2		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Placebo + SOC	-4 points	3		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Ibrutinib 420 mg + SOC	-3 points	12		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Placebo + SOC	-3 points	9		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Ibrutinib 420 mg + SOC	-2 points	5		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Placebo + SOC	-2 points	7		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Ibrutinib 420 mg + SOC	-1 point	0		Participants
Change in the World Health Organization (WHO)-8 Ordinal Scale From Baseline at Study Day 14	Placebo + SOC	-1 point	2		Participants

1 to 10 of 53Source ClinicalTrials.gov

See all 53 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ibrutinib 420 mg + SOC	22
Overall Study	STARTED	Placebo + SOC	24
Overall Study	COMPLETED	Ibrutinib 420 mg + SOC	13
Overall Study	COMPLETED	Placebo + SOC	18
Overall Study	NOT COMPLETED	Ibrutinib 420 mg + SOC	9
Overall Study	NOT COMPLETED	Placebo + SOC	6

Source ClinicalTrials.gov

Adverse events28

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	Ibrutinib 420 mg + SOC	3	22	3
other	ANAEMIA	Blood and lymphatic system disorders	Placebo + SOC	2	24	2
other	NAUSEA	Gastrointestinal disorders	Ibrutinib 420 mg + SOC	2	22	2
other	NAUSEA	Gastrointestinal disorders	Placebo + SOC	1	24	1
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	Ibrutinib 420 mg + SOC	2	22	2
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	Placebo + SOC	3	24	3
other	ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	Ibrutinib 420 mg + SOC	1	22	1
other	ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	Placebo + SOC	2	24	2
other	HYPERTENSION	Vascular disorders	Ibrutinib 420 mg + SOC	3	22	3
other	HYPERTENSION	Vascular disorders	Placebo + SOC	1	24	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ibrutinib 420 mg + SOC	1	22
Total, all-cause mortality	Placebo + SOC	1	24
Total, other adverse events	Ibrutinib 420 mg + SOC	8	22
Total, other adverse events	Placebo + SOC	6	24
Total, serious adverse events	Ibrutinib 420 mg + SOC	4	22
Total, serious adverse events	Placebo + SOC	3	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35493119	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 comparisons3

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

Comparison	Source
Ibrutinib 420 mg + SOC vs Placebo + SOC: deaths from any cause	Trial comparisons
Ibrutinib 420 mg + SOC vs Placebo + SOC: Number of Participants With Adverse Events	Trial comparisons
Ibrutinib 420 mg + SOC vs Placebo + SOC: 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

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

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