Efficacy of Ivermectin for the Treatment and Prophylaxis of COVID-19 disease
- Conditions
- Coronavirus disease 2019
- Registration Number
- PACTR202102535686338
- Lead Sponsor
- agos State Ministry of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 240
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
(1) Provide written informed consent prior to initiation of any study procedures
(2) Understand and agree to comply with planned study procedures
(3) Agree to the collection of nasopharyngeal swabs, sputum, and venous blood per protocol
(4) Be a male or non-pregnant female adult =18 years of age at the time of enrolment
(5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 7 days prior to randomization OR be a household contact (within 7 days) of an individual with lab positive COVID-19 disease.
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30)
2. Pregnant or breastfeeding.
3. Anticipated transfer to another facility that is not a study site within 72 hours.
4. Participants with known haematological diseases (G6PD deficiency)
5. Participants with chronic liver and kidney disease and reaching end-stage.
6. Participants with arrhythmia and chronic heart disease.
7. Participants known to have or hearing loss.
8. Participants known to have a mental disability.
9. Skin disorders (including rash, dermatitis, psoriasis).
10. Allergy to Ivermectin or its analogues.
11. Participants known to have filaria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: 1. Mortality in both groups on day 7<br>2. Resolution of symptoms assessed by clinical status and daily NEWS score until discharge and on Day 7. 3. SARS-CoV-2 clearance time based on samples taken on Days 1, 4, and 6.
- Secondary Outcome Measures
Name Time Method Secondary endpoint: 1. Percentage of household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin that developed SARS-CoV-2 infection compared to household contacts or other enrolled PCR Negative patients that received no prophylactic therapy on or before day 60.<br>2. Time to onset of SARS-CoV-2 infection in household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin compared to those who received no prophylactic therapy, on or before day 60.<br>