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Outpatient Use of Ivermectin in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530474
Recruitment Status : Not yet recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Temple University

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
Covid19 Drug: Ivermectin Pill Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outpatient Use of Ivermectin in COVID-19
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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




Primary Outcome Measures :
  1. Clinical Improvement [ Time Frame: 28 days ]
    Clinical Improvement as measured by a standardized scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530474


Contacts
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Contact: Derek Isenberg, MD 2157078020 derek.isenberg@tuhs.temple.edu
Contact: Nina Gentile, MD 2157078020 nina.gentile@temple.edu

Locations
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United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Contact: Derek Isenberg, MD    215-707-8020    derek.isenberg@tuhs.temple.edu   
Contact: Nina Gentile, MD    215-707-8020    nina.gentile@tuhs.temple.edu   
Sponsors and Collaborators
Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04530474    
Other Study ID Numbers: 1285242
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Temple University:
IVERMECTIN
COVID
Additional relevant MeSH terms:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents