Post-Exposure Prophylaxis with Favipiravir among Household Close Contacts to Confirmed COVID-19 cases: Cluster-Randomized Trial
Phase 2
- Conditions
- Household contacts with SARS-CoV-2 index caseFavipiravir, post-exposure prophylaxis, household, Favipiravir solution, COVID-19, SARS-CoV-2
- Registration Number
- TCTR20210909002
- Lead Sponsor
- Chulabhorn Royal Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Proportion of SARS-COV-2 infection in household contacts between favipiravir PEP group compred with no treatment group 28 days Proportion/ Odds ratio/ Relative risk reduction,Hospitalization rate and mortality of SARS-COV-2 infection in household contacts between favipiravir PEP group compred with no treatment group 28 days Proportion,Severity of SARS-COV-2 infection in household contacts between favipiravir PEP group compred with no treatment group 14 days Proportion,Rate of favipiravir cessation in participants 14 days Number, percent,Adherene of favipiravir tablets compared with favipiravir solutions 7 days Proportion,Adverse events of favipiravir tablets and solutions 14 days proportion