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Outpatient Use of Ivermectin in COVID-19

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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

Tracking Information
First Submitted Date  ICMJE August 26, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date August 28, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
Clinical Improvement [ Time Frame: 28 days ]
Clinical Improvement as measured by a standardized scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Use of Ivermectin in COVID-19
Official Title  ICMJE Outpatient Use of Ivermectin in COVID-19
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Ivermectin Pill
    Ivermecin as a one-time dose
  • Drug: Placebo
    Inactive medication as a one time dose
Study Arms  ICMJE
  • Experimental: Ivermectin
    Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg
    Intervention: Drug: Ivermectin Pill
  • Placebo Comparator: Placebo
    Single dose of 2-4 placebo pills
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Derek Isenberg, MD 2157078020 derek.isenberg@tuhs.temple.edu
Contact: Nina Gentile, MD 2157078020 nina.gentile@temple.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04530474
Other Study ID Numbers  ICMJE 1285242
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Temple University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP