Outpatient Use of Ivermectin in COVID-19

• ClinicalTrials.gov Identifier: NCT04530474
• Recruitment Status: Withdrawn
• First Posted: August 28, 2020
• Last Update Posted: May 26, 2021
• Sponsor: Temple University
• Information provided by (Responsible Party): Temple University

Tracking Information

• First Submitted Date: August 26, 2020
• First Posted Date: August 28, 2020
• Last Update Posted Date: May 26, 2021
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2021)

Clinical Improvement [ Time Frame: 28 days ]

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

Original Primary Outcome Measures (submitted: August 26, 2020)

Clinical Improvement [ Time Frame: 28 days ]

Clinical Improvement as measured by a standardized scale

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Outpatient Use of Ivermectin in COVID-19
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Covid19

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 24, 2021): 0
• Original Estimated Enrollment (submitted: August 26, 2020): 200
• Estimated Study Completion Date: June 30, 2021
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04530474
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Temple University
• Original Responsible Party: Same as current
• Current Study Sponsor: Temple University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Temple University
• Verification Date: May 2021