Trial · NCT04377620

Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)

NCT04377620, Phase 3, Terminated, Incyte Corporation; results first posted 2022-01-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT). Trials, record NCT04377620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04377620

On this page

Trial

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

Title: Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
NCT number: NCT04377620
Status: Terminated
Phases: Phase 3
Enrollment: 211 participants, actual
Lead sponsor: Incyte Corporation
Conditions: COVID-19
Interventions: Placebo, Ruxolitinib
First posted: 2020-05-06
Last updated: 2022-01-19
Results first posted: 2022-01-19

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Have Died Due to Any Cause	Study start to Day 29	To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
Secondary	Number of Ventilator Free Days	Study start to Day 29	Number of days participant did not require mechanical ventilation
Secondary	Number of ICU Free Days	Study start to Day 29	Number of days participant is out of the ICU
Secondary	Oxygen Free Days	Study start to Day 29	Number of days participant did not receive supplemental oxygen
Secondary	Vasopressor Free Days	Study start to Day 29	Number of days without use of vasopressor therapy
Secondary	Hospital Free Days	Study start to Day 29	Number of days Partcipant is out of the hospital
Secondary	Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale	Study start to Days 15 and 29	Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Secondary	Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale	Study start to Days 15 and 29	Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Secondary	Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale	Study Start to Day 29	TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Secondary	Percentage of Participants With the COVID-19 Ordinal Scale Reported	Study start to Day 29	Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Have Died Due to Any Cause	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Percentage	NUMBER
SECONDARY	Number of Ventilator Free Days	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEAN
SECONDARY	Number of ICU Free Days	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEAN
SECONDARY	Oxygen Free Days	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEAN
SECONDARY	Vasopressor Free Days	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEAN
SECONDARY	Hospital Free Days	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEAN
SECONDARY	Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale	Study start to Days 15 and 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale	Study start to Days 15 and 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Percentage of Participants	NUMBER
SECONDARY	Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale	Study Start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.	Days	MEDIAN
SECONDARY	Percentage of Participants With the COVID-19 Ordinal Scale Reported	Study start to Day 29	ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Please note that in the 15mg BID arm, 3 participants were missing scale reporting on Day 29. In the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.	Percentage	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group93

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

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Have Died Due to Any Cause	Ruxolitininb 15mg + Standard of Care (SoC)	50.6		Percentage
Percentage of Participants Who Have Died Due to Any Cause	Ruxolitinib 5mg + Standard of Care (SoC)	52.9		Percentage
Percentage of Participants Who Have Died Due to Any Cause	Placebo + Standard of Care (SoC)	70.2		Percentage
Number of Ventilator Free Days	Ruxolitininb 15mg + Standard of Care (SoC)	6.31	Standard Deviation 9.047	Days
Number of Ventilator Free Days	Ruxolitinib 5mg + Standard of Care (SoC)	4.92	Standard Deviation 8.398	Days
Number of Ventilator Free Days	Placebo + Standard of Care (SoC)	2.98	Standard Deviation 7.228	Days
Number of ICU Free Days	Ruxolitininb 15mg + Standard of Care (SoC)	4.75	Standard Deviation 7.716	Days
Number of ICU Free Days	Ruxolitinib 5mg + Standard of Care (SoC)	4.00	Standard Deviation 7.517	Days
Number of ICU Free Days	Placebo + Standard of Care (SoC)	2.45	Standard Deviation 6.362	Days
Oxygen Free Days	Ruxolitininb 15mg + Standard of Care (SoC)	2.66	Standard Deviation 6.073	Days

1 to 10 of 93Source ClinicalTrials.gov

See all 93 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ruxolitininb 15mg + Standard of Care	77
Overall Study	STARTED	Ruxolitinib 5mg + Standard of Care (SoC)	87
Overall Study	STARTED	Placebo + Standard of Care (SoC)	47
Overall Study	COMPLETED	Ruxolitininb 15mg + Standard of Care	35
Overall Study	COMPLETED	Ruxolitinib 5mg + Standard of Care (SoC)	37
Overall Study	COMPLETED	Placebo + Standard of Care (SoC)	11
Overall Study	NOT COMPLETED	Ruxolitininb 15mg + Standard of Care	42
Overall Study	NOT COMPLETED	Ruxolitinib 5mg + Standard of Care (SoC)	50
Overall Study	NOT COMPLETED	Placebo + Standard of Care (SoC)	36

Source ClinicalTrials.gov

Adverse events312

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	Alanine aminotransferase increased	Investigations	Ruxolitinib 15 mg BID	9	77	9
other	Alanine aminotransferase increased	Investigations	Ruxolitinib 5 mg BID	12	87	13
other	Alanine aminotransferase increased	Investigations	Placebo	5	45	5
other	Alanine aminotransferase increased	Investigations	Total	26	209	27
other	Anaemia	Blood and lymphatic system disorders	Ruxolitinib 15 mg BID	12	77	13
other	Anaemia	Blood and lymphatic system disorders	Ruxolitinib 5 mg BID	21	87	23
other	Anaemia	Blood and lymphatic system disorders	Placebo	9	45	9
other	Anaemia	Blood and lymphatic system disorders	Total	42	209	45
other	Anxiety	Psychiatric disorders	Ruxolitinib 15 mg BID	6	77	6
other	Anxiety	Psychiatric disorders	Ruxolitinib 5 mg BID	4	87	4

1 to 10 of 312Source ClinicalTrials.gov

See all 312 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ruxolitinib 15 mg BID	42	77
Total, all-cause mortality	Ruxolitinib 5 mg BID	48	87
Total, all-cause mortality	Placebo	36	47
Total, all-cause mortality	Total	124	209
Total, other adverse events	Ruxolitinib 15 mg BID	35	77
Total, other adverse events	Ruxolitinib 5 mg BID	46	87
Total, other adverse events	Placebo	21	45
Total, other adverse events	Total	102	209
Total, serious adverse events	Ruxolitinib 15 mg BID	23	77
Total, serious adverse events	Ruxolitinib 5 mg BID	21	87

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36226977	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 comparisons0

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

None in this release.

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/NCT04377620

GET https://conductscience.org/api/trials/v1/NCT04377620/results?page=2

API reference For AI assistants