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| Column | Value |
|---|---|
| Trial registration number | NCT04362137 |
|
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 : Oct. 27, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 27, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
infoservice.novartis@novartis.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-24 |
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Recruitment status
Last imported at : Nov. 13, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Completed |
|
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: patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed. male and female patients aged ≥ 12 years (or ≥ the lower age limit allowed by health authority and/or ethics committee/institutional review board approvals). patients with coronavirus (sars-cov-2) infection confirmed by polymerase chain reaction (pcr) test or another rapid test from the respiratory tract prior to randomization. patients currently hospitalized or will be hospitalized prior to randomization. patients, who meet at least one of the below criteria: - pulmonary infiltrates (chest x ray or chest ct scan); - respiratory frequency ≥ 30/min; - requiring supplemental oxygen; - oxygen saturation ≤ 94% on room air; - arterial oxygen partial pressure (pao2)/ fraction of inspired oxygen (fio2) < 300mmhg (1mmhg=0.133kpa) (corrective formulation should be used for higher altitude regions (over 1000m). |
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Exclusion criteria
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib. presence of severely impaired renal function defined by serum creatinine > 2 mg/dl (>176.8 μmol/l), or have estimated creatinine clearance < 30 ml/min measured or calculated by cockroft gault equation or calculated by the updated bedside schwartz equation. suspected uncontrolled bacterial, fungal, viral, or other infection (besides covid-19). currently intubated or intubated between screening and randomization. in intensive care unit (icu) at time of randomization. intubated or in icu for covid-19 disease prior to screening. patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra). unable to ingest tablets at randomization. pregnant or nursing (lactating) women |
|
Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Novartis Pharmaceuticals |
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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 |
100 |
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Countries
Last imported at : Oct. 27, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Argentina;Brazil;Colombia;France;Germany;Mexico;Peru;Russia;Spain;Turkey;United Kingdom;United States |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Oct. 27, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
432 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Proportion of patients who die, develop respiratory failure [require mechanical ventilation] or require intensive care unit (ICU) care |
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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": "", "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"}] |