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| Column | Value |
|---|---|
| Trial registration number | NCT04377620 |
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Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
medinfo@incyte.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-06 |
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Recruitment status
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- 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. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Incyte Corporation |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
12 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Russia;United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
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Total sample size
Last imported at : March 17, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
211 |
|
primary outcome
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
Percentage of Participants Who Have Died Due to Any Cause |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "5mg", "treatment_id": 1135, "treatment_name": "Ruxolitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "15mg", "treatment_id": 1135, "treatment_name": "Ruxolitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |