Covid19 Clinical Trial
Official title:
Outpatient Use of Ivermectin in COVID-19
NCT number | NCT04530474 |
Other study ID # | 1285242 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 1, 2021 |
Est. completion date | June 30, 2021 |
Verified date | May 2021 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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: 1. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Improvement | Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO) | 28 days |
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