CClinicalTrials.gg
Sign In
TerminatedNCT04377620Updated Jan 19, 2022Results posted

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

A Phase 3 interventional study of Placebo and Ruxolitinib in COVID-19, sponsored by Incyte Corporation. Terminated at 36 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment

Why this study was terminated
Study terminated by sponsor
Phase
Phase 3
Study type
Interventional
Enrollment
211
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.

02

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • Cytokine storm
  • COVID-19
  • ARDS
  • SARS-CoV-2
  • ruxolitinib
  • pneumonia
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 211 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant or guardian health proxy must provide informed consent before any study assessment is performed.
  • Male or female participants aged ≥ 12 years.
  • Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.
  • Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.

Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.

Exclusion criteria

Exclusion Criteria:

  • Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
  • Presence of severely impaired renal function defined by estimated creatinine clearance \< 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.
  • In the opinion of the investigator, unlikely to survive for > 24 hours from randomization.
  • Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
  • Currently receiving ECMO.
  • Participant may not be sharing a ventilator, or co-ventilating, with any other patient.
  • Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.
  • Treatment with a JAK inhibitor within 30 days of randomization.
  • Participants who are on long-term use of antirejection or immunomodulatory drugs.
  • Pregnant or nursing (lactating) women.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
211 participants (actual)

Study arms

  • Placebo comparator
    Placebo + Standard of Care (SoC)

    Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

    Drug: Placebo

  • Experimental
    Ruxolitinib 5mg + Standard of Care (SoC)

    Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

    Drug: Ruxolitinib

  • Experimental
    Ruxolitininb 15mg + Standard of Care (SoC)

    Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.

    Drug: Ruxolitinib

Interventions

  • DrugPlacebo

    Placebo administered BID approximately 12 hours apart

  • DrugRuxolitinib

    Ruxolitinb administered BID approximately 12 hours apart

    Also known as: INCB018424, Oral Jak Inhibitor

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Have Died Due to Any Cause

    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.

    Time frame: Study start to Day 29

Secondary outcomes

  1. Number of Ventilator Free Days

    Number of days participant did not require mechanical ventilation

    Time frame: Study start to Day 29

  2. Number of ICU Free Days

    Number of days participant is out of the ICU

    Time frame: Study start to Day 29

  3. Oxygen Free Days

    Number of days participant did not receive supplemental oxygen

    Time frame: Study start to Day 29

  4. Vasopressor Free Days

    Number of days without use of vasopressor therapy

    Time frame: Study start to Day 29

  5. Hospital Free Days

    Number of days Partcipant is out of the hospital

    Time frame: Study start to Day 29

  6. Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale

    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

    Time frame: Study start to Days 15 and 29

  7. Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale

    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

    Time frame: Study start to Days 15 and 29

  8. Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale

    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

    Time frame: Study Start to Day 29

  9. Percentage of Participants With the COVID-19 Ordinal Scale Reported

    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

    Time frame: Study start to Day 29

  10. Change in the COVID-19 9-point Ordinal Scale

    Change in the Clinical status of participant 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

    Time frame: Study start to Days 15 and 29

  11. Change in SOFA Score

    Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

    Time frame: from baseline to Days 3, 5, 8, 11, 15, and 29

  12. Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events

    Treatment-emergent AEs are judged as related by the investigator or have a missing causality.

    Time frame: Study start to Day 29

07

Results

Posted Jan 19, 2022

Participant flow

This study was conducted at 33 study centers in the United States (29) and Russia (4), and 211 participants were enrolled and analyzed for efficacy.; 209 participants were analyzed for safety. Enrollment in this study was stopped early and was not due to safety reasons.

Participant flow — Overall Study
MilestoneRuxolitininb 15mg + Standard of CareRuxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Started778747
Completed353711
Not completed425036
Withdrew: Death424836
Withdrew: Withdrawal by subject020

Outcome measures

PrimaryPercentage of Participants Who Have Died Due to Any Cause

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.

Time frame:
Study start to Day 29
Reported as:
Number · Percentage
Percentage of Participants Who Have Died Due to Any Cause
PercentageRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Percentage of Participants Who Have Died Due to Any Cause50.652.970.2
Statistical analysis
  • Ruxolitininb 15mg + Standard of Care (SoC) · Mixed Models Analysis · p = 0.0292 · Odds ratio (or): 0.46 · 95% CI 0.201 to 1.028logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.
  • Ruxolitinib 5mg + Standard of Care (SoC) · Mixed Models Analysis · p = 0.0280 · Odds ratio (or): 0.42 · 95% CI 0.171 to 1.023logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.
SecondaryNumber of Ventilator Free Days

Number of days participant did not require mechanical ventilation

Time frame:
Study start to Day 29
Reported as:
Mean · Days
Number of Ventilator Free Days
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Number of Ventilator Free Days6.31 ± 9.0474.92 ± 8.3982.98 ± 7.228
SecondaryNumber of ICU Free Days

Number of days participant is out of the ICU

Time frame:
Study start to Day 29
Reported as:
Mean · Days
Number of ICU Free Days
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Number of ICU Free Days4.75 ± 7.7164.00 ± 7.5172.45 ± 6.362
SecondaryOxygen Free Days

Number of days participant did not receive supplemental oxygen

Time frame:
Study start to Day 29
Reported as:
Mean · Days
Oxygen Free Days
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Oxygen Free Days2.66 ± 6.0732.98 ± 6.7451.53 ± 4.690
SecondaryVasopressor Free Days

Number of days without use of vasopressor therapy

Time frame:
Study start to Day 29
Reported as:
Mean · Days
Vasopressor Free Days
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Vasopressor Free Days8.95 ± 11.7387.53 ± 10.8614.47 ± 9.322
SecondaryHospital Free Days

Number of days Partcipant is out of the hospital

Time frame:
Study start to Day 29
Reported as:
Mean · Days
Hospital Free Days
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Hospital Free Days2.09 ± 4.8892.35 ± 5.2591.38 ± 3.976
SecondaryPercentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale

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

Time frame:
Study start to Days 15 and 29
Reported as:
Number · Percentage of Participants
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale
Percentage of ParticipantsRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Day 1522.1 (13.4 to 33.)15.3 (8.4 to 24.7)10.6 (3.5 to 23.1)
Day 2929.7 (19.7 to 41.5)25.3 (16.4 to 36.0)17.0 (7.6 to 30.8)
SecondaryPercentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale

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

Time frame:
Study start to Days 15 and 29
Reported as:
Number · Percentage of Participants
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale
Percentage of ParticipantsRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Day 1541.6 (30.4 to 53.4)32.9 (23.1 to 44.0)21.3 (10.7 to 35.7)
Day 2943.2 (31.8 to 55.3)32.5 (22.6 to 43.7)17.0 (7.6 to 30.8)
SecondaryTime to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale

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

Time frame:
Study Start to Day 29
Reported as:
Median · Days
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale
DaysRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale0.91 (0.711 to 0.992)0.75 (0.614 to 0.867)0.61 (0.408 to 0.818)
SecondaryPercentage of Participants With the COVID-19 Ordinal Scale Reported

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

Time frame:
Study start to Day 29
Reported as:
Number · Percentage
Percentage of Participants With the COVID-19 Ordinal Scale Reported
PercentageRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Score 0 = Uninfected04.60
Score 1 = Ambulatory (no limitation of activities)2.602.1
Score 2 = Ambulatory (limitation of activities)16.916.110.6
Score 3 = Hospitalized/Mild Disease (no oxygen therapy)01.10
Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs)9.11.14.3
Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen)3.94.60.0
Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization)10.48.02.1
Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support)2.68.010.6
Score 8 - Death50.651.770.2
SecondaryChange in the COVID-19 9-point Ordinal Scale

Change in the Clinical status of participant 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

Time frame:
Study start to Days 15 and 29
Reported as:
Mean · Score on a Scale
Change in the COVID-19 9-point Ordinal Scale
Score on a ScaleRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Change from Day 1 to Day 15-0.4 ± 1.80-0.2 ± 1.730.6 ± 1.69
Change from Day 1 to Day 29-0.5 ± 2.53-0.4 ± 2.570.4 ± 2.23
SecondaryChange in SOFA Score

Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).

Time frame:
from baseline to Days 3, 5, 8, 11, 15, and 29
Reported as:
Mean · Scores on a Scale
Change in SOFA Score
Scores on a ScaleRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Baseline - Day 19.2 ± 2.359.6 ± 2.539.4 ± 2.69
Day 3-0.1 ± 2.770.4 ± 3.142.6 ± 5.89
Day 50.2 ± 4.270.7 ± 4.583.3 ± 6.60
Day 81.9 ± 6.772.0 ± 6.304.5 ± 7.87
Day 112.5 ± 7.642.0 ± 7.026.5 ± 8.26
Day 154.2 ± 9.244.1 ± 7.7210.3 ± 7.89
Day 2910.3 ± 8.5410.4 ± 7.0412.8 ± 5.41
SecondaryNumber and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events

Treatment-emergent AEs are judged as related by the investigator or have a missing causality.

Time frame:
Study start to Day 29
Reported as:
Count of participants · Participants
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
ParticipantsRuxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)
Treatment-Emergent Adverse Events (TEAEs)222311
Serious TEAEs232111

Adverse events

Collected over Up to approximately 2 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ruxolitinib 15 mg BID42/77 (54.5%)23/77 (29.9%)35/77 (45.5%)
Ruxolitinib 5 mg BID48/87 (55.2%)21/87 (24.1%)46/87 (52.9%)
Placebo36/47 (76.6%)11/45 (24.4%)21/45 (46.7%)
Total124/209 (59.3%)55/209 (26.3%)102/209 (48.8%)
Most frequent serious events
Showing 10 of 54
Most frequent serious events
EventRuxolitinib 15 mg BIDRuxolitinib 5 mg BIDPlaceboTotal
HypoxiaRespiratory, thoracic and mediastinal disorders1/771/873/455/209
PneumoniaInfections and infestations2/774/872/458/209
Alanine aminotransferase increasedInvestigations3/771/871/455/209
PneumothoraxRespiratory, thoracic and mediastinal disorders3/770/871/454/209
SepsisInfections and infestations3/771/870/454/209
HypotensionVascular disorders1/773/871/455/209
Aspartate aminotransferase increasedInvestigations2/771/871/454/209
HypertensionVascular disorders2/771/870/453/209
Acute kidney injuryRenal and urinary disorders1/772/870/453/209
Blood alkaline phosphatase increasedInvestigations0/772/870/452/209
Most frequent other events
Showing 10 of 24
Most frequent other events
EventRuxolitinib 15 mg BIDRuxolitinib 5 mg BIDPlaceboTotal
AnaemiaBlood and lymphatic system disorders12/7721/879/4542/209
HypernatraemiaMetabolism and nutrition disorders8/777/877/4522/209
Alanine aminotransferase increasedInvestigations9/7712/875/4526/209
Aspartate aminotransferase increasedInvestigations10/7711/873/4524/209
HypertensionVascular disorders5/7711/875/4521/209
HypokalaemiaMetabolism and nutrition disorders9/779/874/4522/209
HyperglycaemiaMetabolism and nutrition disorders3/778/871/4512/209
HypoalbuminaemiaMetabolism and nutrition disorders1/777/874/4512/209
PyrexiaGeneral disorders2/775/874/4511/209
AnxietyPsychiatric disorders6/774/871/4511/209

Baseline characteristics

Intent-to-treat (ITT) population included all participants who were randomized to the study.

Age, Continuous
Age, Continuous(Years)Ruxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)Total
Mean63.6 ± 12.9263.6 ± 12.2562.5 ± 13.3463.4 ± 12.69
Sex: Female, Male
Sex: Female, Male(Participants)Ruxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)Total
Female29321374
Male485534137
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ruxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)Total
Hispanic or Latino21211254
Not Hispanic or Latino536434151
Unknown or Not Reported3216
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ruxolitininb 15mg + Standard of Care (SoC)Ruxolitinib 5mg + Standard of Care (SoC)Placebo + Standard of Care (SoC)Total
American Indian or Alaska Native0022
Asian3317
Native Hawaiian or Other Pacific Islander0000
Black or African American912526
White576131149
More than one race0000
Unknown or Not Reported811827
08

Study locations

36 sites
  • Honor Health Research Institute
    Scottsdale, Arizona 85258, United States
  • Sharp Memorial Hospital
    San Diego, California 92123, United States
  • Georgetown University Hospital
    Washington, District of Columbia 20007, United States
  • Teradan Clinical Trials
    Brandon, Florida 33511, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • Tampa General Hospital
    Tampa, Florida 33606, United States
  • University of South Florida
    Tampa, Florida 33613, United States
  • Northshore University Health System
    Chicago, Illinois 60678, United States
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Indiana University Simon Cancer Center
    Indianapolis, Indiana 46202, United States
  • Indiana University Health Central Indiana Cancer Centers
    Indianapolis, Indiana 46219, United States
  • East Jefferson General Hospital
    Metairie, Louisiana 70006, United States
  • Johns Hopkins University
    Baltimore, Maryland 21224, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • Lahey Hospital & Medical Center
    Burlington, Massachusetts 01805, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
  • Healthpartners Cancer Care Center - Regions Hospital
    Saint Paul, Minnesota 55101, United States
  • Mercy Research
    Springfield, Missouri 65804, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Rutgers Njms Clinical Research Unit
    Newark, New Jersey 07103, United States
  • Holy Name Medical Center
    Teaneck, New Jersey 07666, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • East Carolina University
    Greenville, North Carolina 27858, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • Kettering Cancer Care
    Dayton, Ohio 45429, United States
  • Jefferson University Hospitals
    Philadelphia, Pennsylvania 19107, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • West Penn Hospital
    Pittsburgh, Pennsylvania 15224, United States
  • Allegheny Health Network
    Wexford, Pennsylvania 15090, United States
  • St David'S Medical Center
    Austin, Texas 78705, United States
  • University of Texas Health Science Center At Houston - McGovern Medical School
    Houston, Texas 77030, United States
  • University of Texas Health Science Cente
    San Antonio, Texas 78229, United States
  • Wenatchee Valley Hospital and Clinics
    Wenatchee, Washington 98801, United States
  • Aurora Research Institute
    Milwaukee, Wisconsin 53233, United States
  • Sbih City Hospital 15
    Saint Petersburg, 198205, Russian Federation
09

References and documents

Publications

  • Rein L, Calero K, Shah R, Ojielo C, Hudock KM, Lodhi S, Sadaka F, Bellam S, Palma C, Hager DN, Daniel J, Schaub R, O'Hayer K, Theodoropoulos NM. Randomized Phase 3 Trial of Ruxolitinib for COVID-19-Associated Acute Respiratory Distress Syndrome. Crit Care Med. 2022 Dec 1;50(12):1701-1713. doi: 10.1097/CCM.0000000000005682. Epub 2022 Oct 13. PubMed 36226977 ↗

Study documents

  • Study protocol · Jun 2, 2020
  • Statistical analysis plan · Feb 22, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04377620
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
May 6, 2020
Start date
May 24, 2020
Primary completion
Feb 26, 2021
Completion
Feb 26, 2021
Results posted
Jan 19, 2022
Last update
Jan 19, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19→

Other studies from this sponsor

Incyte Corporation

Start the discussion