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WHO report
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivermectin | Experimental | Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg |
|
| Placebo | Placebo Comparator | Single dose of 2-4 placebo pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin Pill | Drug | Ivermecin as a one-time dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement | Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO) | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
Known history of Ivermectin allergy
Hypersensitivity to any component of Stromectol®
COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan
Fever or cough present for more than 7 days
Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening.
The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study:
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Drug |
Inactive medication as a one time dose |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |