Clinical trial NCT04530474: Outpatient Use of Ivermectin in COVID-19
Official title: Outpatient Use of Ivermectin in COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Covid19
Keywords: IVERMECTIN
COVID
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Improvement
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References: