Study to assess efficacy of Ivermectin as prophylaxis of COVID -19
Phase 2
- Registration Number
- CTRI/2020/05/025333
- Lead Sponsor
- R D Gardi Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Following are eligible to participate after giving written consent/assent -
1. Healthy health care workers
2. Contact of COVID 19
Exclusion Criteria
1. Un healthy 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Ivermectin as prophylaxis of virus <br/ ><br> <br/ ><br>Outcome indicators are : <br/ ><br>1. Resolution of sign and symptoms of COVID 19 <br/ ><br>2. Negative RTPCR done 48 hours after Ivermectin dose <br/ ><br>OR <br/ ><br>Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay. <br/ ><br>Timepoint: Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.
- Secondary Outcome Measures
Name Time Method Overall safety of the study drug <br/ ><br> <br/ ><br>The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form. <br/ ><br>Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee <br/ ><br>Lab values : CT value of RTPCR as reported in primary outcome. <br/ ><br>Timepoint: 7 Days