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Outpatient Use of Ivermectin in COVID-19

Primary Purpose

Covid19

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ivermectin Pill
Placebo
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring IVERMECTIN, COVID

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Temple University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin

Placebo

Arm Description

Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg

Single dose of 2-4 placebo pills

Outcomes

Primary Outcome Measures

Clinical Improvement
Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)

Secondary Outcome Measures

Full Information

First Posted
August 26, 2020
Last Updated
May 24, 2021
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT04530474
Brief Title
Outpatient Use of Ivermectin in COVID-19
Official Title
Outpatient Use of Ivermectin in COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
WHO report
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
IVERMECTIN, COVID

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin
Arm Type
Experimental
Arm Description
Single dose of 0.15-2 mg/kg/dose to a maximum of 12 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of 2-4 placebo pills
Intervention Type
Drug
Intervention Name(s)
Ivermectin Pill
Intervention Description
Ivermecin as a one-time dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive medication as a one time dose
Primary Outcome Measure Information:
Title
Clinical Improvement
Description
Clinical Improvement as measured by the inFLUenza Patient-Reported Outcome (FLU-PRO)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms highly suspicious for COVID-19. Age at least 18 years Negative pregnancy test for women of child bearing age Able to consent to participate in the study. Exclusion Criteria: Known history of Ivermectin allergy Hypersensitivity to any component of Stromectol® COVID-19 Pneumonia identified by chest X-ray or high resolution CT scan Fever or cough present for more than 7 days Positive IgG against SARS-CoV-2 by rapid test if available on baseline screening. The following co-morbidities (or any other disease that, in the opinion of the investigators, might interfere with the study: Immunosuppression HIV Acute or chronic renal failure Current neoplasm 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. 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.
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outpatient Use of Ivermectin in COVID-19

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