| Trial registration number
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ISRCTN44151777 |
Full text link
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN44151777
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First author
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dalton Rivabem MD
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Contact
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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daltonrivabem@yahoo.com.br
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Registration date
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-01-24
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Recruitment status
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Age =18 years. 2. Confirmed or suspected infection for COVID-19. 3. Need for hospitalization, infirmary or intensive care unit (ICU). 4. Chest tomography with image compatible with COVID-19.
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Exclusion criteria
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Known history of allergy to metrilprednisolone. 2. Use of corticosteroids for another condition. 3. Patient's refusal to participate in the study. 4. Pregnant or breastfeeding women. 5. Contraindication to the use of corticosteroids.
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Number of arms
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Hospital do Rocio
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Inclusion age min
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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400
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primary outcome
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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All-cause mortality rates at 28 days after randomization measured using patient records
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Notes
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : Feb. 3, 2022, 6:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}]
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