Outpatient Use of Ivermectin in COVID-19
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ivermectin Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg |
Drug: Ivermectin Pill
Ivermecin as a one-time dose
|
| Placebo Comparator: Placebo Single dose of 2-4 placebo pills |
Drug: Placebo
Inactive medication as a one time dose
|
Outcome Measures
Primary Outcome Measures
- Clinical Improvement [28 days]
Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Symptoms highly suspicious for COVID-19.
-
Age at least 18 years
-
Negative pregnancy test for women of child bearing age
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Able to consent to participate in the study.
Exclusion Criteria:
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Known history of Ivermectin allergy
-
Hypersensitivity to any component of Stromectol®
-
COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan
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Fever or cough present for more than 7 days
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Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening.
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The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study:
-
Immunosuppression
-
HIV
-
Acute or chronic renal failure
-
Current neoplasm
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
Sponsors and Collaborators
- Temple University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1285242