Outpatient Use of Ivermectin in COVID-19
Purpose
Covid 19, a novel coronavirus, causes infection that, while mild to moderate in many people, can lead to severe disease in a significant portion. Currently, it is expected that the majority, 81%, of patients with COVID-19 will have mild to moderate disease, with 14% having more severe disease (2). There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease. Simple, safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection. Ivermectin is a drug initially synthesized and used as an anthelmintic. It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin α/β-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function. A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours. A recent multi-continent retrospective study of 1,400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 1.4% versus 8.5%. Given these findings and its safety profile, cost and ease of administration, Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection.
Condition
- Covid19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Symptoms highly suspicious for COVID-19. 2. Age at least 18 years 3. Negative pregnancy test for women of child bearing age 4. Able to consent to participate in the study.
Exclusion Criteria
- Known history of Ivermectin allergy 2. Hypersensitivity to any component of Stromectol® 3. COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan 4. Fever or cough present for more than 7 days 5. Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening. 6. The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study: 1. Immunosuppression 2. HIV 3. Acute or chronic renal failure 4. Current neoplasm 7. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal within the prior 6 months if available OR clinical evidence of liver failure with jaundice, ascites, encephalopathy. 8. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Ivermectin |
Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg |
|
Placebo Comparator Placebo |
Single dose of 2-4 placebo pills |
|
Recruiting Locations
More Details
- NCT ID
- NCT04530474
- Status
- Withdrawn
- Sponsor
- Temple University