| Trial registration number
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ISRCTN90437126 |
Full text link
Last imported at : Dec. 15, 2021, 3 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.isrctn.com/ISRCTN90437126
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First author
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Taciana de Castro
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Contact
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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taciana@scinetinstitute.com
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Registration date
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-11-17
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Recruitment status
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Adult participants susceptible to be infected by SARS-CoV-19 (not previous infection) tested negative for IgM and IgG immunological test 2. No symptoms of COVID-19 3. Written informed consent signed by participating for the study
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Exclusion criteria
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Pregnant or breastfeeding 2. Known allergy to study medications used at intervention 3. Known or reported history of liver disease 4. Use of coumarin (anticoagulant)
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Number of arms
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Federal University of Pernambuco
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Inclusion age min
Last imported at : Dec. 4, 2020, 12:45 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. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Brazil
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Type of patients
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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800
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primary outcome
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Covid-19 case diagnosis (conversion from being asymptomatic pre-treatment to symptomatic post-treatment for COVID-19) by using a questionnaire for screening clinical symptoms of COVID-19; at baseline; and during the follow up at 7; 14; 30 and 90 days . All clinically diagnosed COVID-19 cases will be confirmed by serologic IgM and IgG anti-SARS-CoV2 test at 14 days post-initial symptoms.
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Notes
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 3
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Arms
Last imported at : Dec. 4, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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