Study on the effects of using ivermectin to prevent COVID-19 in an adult population in Brazil
Phase 3
- Conditions
- Prevention of COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN90437126
- Lead Sponsor
- Federal University of Pernambuco
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
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
Exclusion Criteria
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method <br> 1. Clinical status of COVID-19 using the WHO Clinical Progression Scale measured at 14 and 30 days after COVID-19 diagnosis (if applicable)<br> 2. Incidence of severe COVID-19 cases determined by active cases detection and defined by WHO Clinical Progression Scale at days 14 and 30 after treatment<br> 3. Rate of adverse events using active case detection with questionnaire and adverse events grades (mild, moderate and severe) using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at days 2 and 7 after treatment<br> 4. Hospitalization rate at 7,14, 30 and 90 days measured using patient records<br> 5. Deaths at the follow-up period (90 days) measured using patient records<br>