| Trial registration number
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RBR-8969zg |
Full text link
Last imported at : Jan. 8, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://ensaiosclinicos.gov.br/rg/RBR-8969zg
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First author
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Julio Alencar
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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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julio.alencar@hc.fm.usp.br
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-04-13
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Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Volunteers, Both genders, Admitted to the Emergency Department with diagnosis of Acute Respiratory Syndrome, presumed or confirmed, Age equal to or greater than 18 years, Informed consent form (ICF) signed by the patient or legal guardian.
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Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients with known allergy to N acetylcysteine, Pregnant women, In need of immediate mechanical ventilation or Refusal or inability to obtain consent
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Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Universidade de São Paulo
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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None
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Countries
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Severe/critical disease at enrollment
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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7: Severe/critical disease at enrollment
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Total sample size
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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0
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primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Reduction in in-hospital mortality in 5%; verified by medical record analysis; in patients receiving N-acetylcysteine compared to the group receiving Placebo
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Notes
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Dec. 15, 2020, 2:47 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 18, "treatment_name": "Acetylcysteine", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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