Outpatient Use of Ivermectin in COVID-19

Covid19 Clinical Trial

Official title:

Outpatient Use of Ivermectin in COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04530474
• Other study ID #: 1285242
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2021
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Ivermectin Pill
Ivermecin as a one-time dose
• Placebo
Inactive medication as a one time dose

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Improvement	Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)	28 days