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Trial - NCT04477993


Column Value
Trial registration number NCT04477993
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04477993

First author
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Vanderson Rocha, MD.PhD

Contact
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

vanderson.rocha@hc.fm.usp.br

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-20

Recruitment status
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - patients hospitalized with sars-cov-2 pneumonia confirmed by rt-pcr or serology (iga); - pao2/fio2 < 300 (not fully explained by heart failure or volume overload) or spo2 < 90% on room air.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- symptom onset > 14 days; - neutrophil count < 1,000/mm3; - platelets < 50,000/mm3; - icu care at enrollment; - on invasive mechanical ventilation at enrollment; - current use of experimental therapy for covid-19 (except: azithromycin or corticosteroids) - uncontrolled arterial hypertension; - current or previous use of systemic immunosuppressive therapy in the last 30 days; - pregnancy or lactation; - estimated creatinine clearance < 30 ml/min or receiving crrt or intermittent hemodialysis; - allergy to ruxolitinib; - active tuberculosis; - hiv seropositivity; - prior history of progressive multifocal leukoencephalopathy; - use of any jak inhibitor in the last 30 days before study enrollment; - not qualifying according to investigators' perception.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Vanderson Geraldo Rocha

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

95

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : April 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

5

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

A composite outcome of death or ICU admission or mechanical ventilation at day 14.

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2/Phase 3

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"}]