An Open Label Randomized Controlled Trial of Ivermectin Plus Favipiravir-Based Standard of Care versus Favipiravir-Based Standard of Care For Treatment of Moderate COVID-19 in Thailand
Phase 4
Recruiting
- Conditions
- improvement in the WHO-category ordinal scale by 2 points in moderate COVID-19Ivermectin,Favipiravir,COVID-19,Treatment,Thailand
- Registration Number
- TCTR20220427005
- Lead Sponsor
- Dr. Anucha Apisarnthanarak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
1. Moderate COVID-19 infection by RT-PCR technique
2. Date of onset <7 days
3. Admitted at Thammasat University hospital or Thammasat Field hospital
Exclusion Criteria
1. Asymptomatic patient
2. Patient with severe symptom (on high flow nasal canular oxygen or above)
3. Pregnancy women
4. Lactating women
5. Chronic liver disease
6. Meningitis patient
7. Epilepsy who on barbiturate, benzodiazepine or valproic aside as medication
8. Who can't tolerate to oral feeding
9. Who participate other experimental drugs
10. Who had symptom that might mimicking severe drug adverse reaction (uncontrollable nausea/vomitting, liver function test 3 times UNL or above)
11. Who wish not to participate the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in WHO-category ordinal scale by 2 points at day 3, 7, 14, 21 after treatment WHO-category ordinal scale
- Secondary Outcome Measures
Name Time Method Duration of illness at day 3, 7, 14, 21 after treatment days,development of severe COVID-19 at day 3, 7, 14, 21 after treatment worsening in WHO-category ordinal scale by 2 points, requiring intensive care unit admission,Adverse reaction at day 3, 7 after treatment By questionnaire