| Trial registration number
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RBR-7nzwkpg |
Full text link
Last imported at : Jan. 30, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://ensaiosclinicos.gov.br/rg/RBR-7nzwkpg
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First author
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Anna Piovezan
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Contact
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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anna.piovezan@unisul.br
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Registration date
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-01-06
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Recruitment status
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Treatment
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Inclusion criteria
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients over 18 years of age, clinical suspicion of Covid-19, oxygen saturation between 93% and 97%, at least one more symptom according to the Ministry of Health criteria including tiredness or shortness of breath, fever and chills reported, cough and loss of smell or taste, positive result for the D-dimer test
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Exclusion criteria
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients with active infectious diseases, immunosuppressive diseases or active cancer, pregnant or lactating women, known renal failure, current use of anticoagulants, contraindication to the use of Edoxaban or Moxifloxacin
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Number of arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Universidade do Sul de Santa Catarina
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Inclusion age min
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Mild/moderate disease at enrollment
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Severity scale
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2: Mild/moderate disease at enrollment
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Total sample size
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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0
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primary outcome
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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frequency of individuals who required hospitalization after starting treatment (in %)
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Notes
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Dec. 10, 2021, 2 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Feb. 11, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 1636, "treatment_name": "Edoxaban+moxifloxacine", "treatment_type": "Coagulation modifiers+antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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