Trial registration number
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TCTR20210909002 |
Full text link
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://www.thaiclinicaltrials.org/show/TCTR20210909002
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First author
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Taweegrit Siripongboonsitti
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Contact
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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taweegrit.sir@pccms.ac.th
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Registration date
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-09-09
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Recruitment status
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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single-center
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Study aim
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. age equal or more than 7-year-old
2. Close contact with SARS-CoV-2 index case confirmed with SARS-CoV-2 PCR
3. Contact with index case less than 72 hours before enrollment
4. Comminacability by electronic module
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Exclusion criteria
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Household contacts who have symptoms compatible with SARS-CoV-2 infection definition or SARS-CoV-2 PCR showed a positive result.
2. Previous receiving favipiravir in 14 days
3. Contraindication of favipiravir treatment
4. Pregnancy in any trimester
5. Allergy to favipiravir
6. Moderate to severe liver disease
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Number of arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Chulabhorn Royal Academy
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Inclusion age min
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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7
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Inclusion age max
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Thailand
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Type of patients
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Close contacts to covid patients
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Severity scale
Last imported at : Oct. 7, 2021, 9:30 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 : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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156
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primary outcome
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Proportion of SARS-COV-2 infection in household contacts between favipiravir PEP group compred with no treatment group 14 days Proportion/ Odd ratio/ Relative Risk Reduction
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Notes
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2/Phase 3
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Arms
Last imported at : Oct. 7, 2021, 9:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "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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