Trial registration number
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RBR-6wgwxsy |
Full text link
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://ensaiosclinicos.gov.br/rg/RBR-6wgwxsy
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First author
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Evônio Campelo
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Contact
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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evoniocampelo55@gmail.com
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Registration date
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2022-03-14
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Recruitment status
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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outpacients with positive diagnosis for COVID-19
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Exclusion criteria
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients with indication for hospital admission, patients with other protease inhibitors, pregnant, infants, more than 5 days from the onset of symptoms, HIV positive patients
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Number of arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Hospital das Clínicas da Universidade Federal de Pernambuco
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Inclusion age min
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild disease at enrollment
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Severity scale
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1: Mild disease at enrollment
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Total sample size
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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953
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primary outcome
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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To evaluate the number of hospitalizations; verified by the percentage of hospitalization of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.;To evaluate hospital discharge rate; verified by the percentage of discharge rate of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.;To evaluate hospital death rate; verified by the percentage of death rate of the experimental and control groups; based on a finding of a variation of at least 5% in pre- and post-intervention measurements.
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Notes
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2
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Arms
Last imported at : April 8, 2022, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2427, "treatment_name": "Atazanavir+doxycycline+ritonavir", "treatment_type": "Antivirals+antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1422, "treatment_name": "Atazanavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
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