Outpatient Use of Ivermectin in COVID-19

NCT04530474 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 1285242
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

IVERMECTIN; COVID

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

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

  28 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

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

Drug: Ivermectin Pill

Placebo

PLACEBO COMPARATOR

Single dose of 2-4 placebo pills

Drug: Placebo

Interventions

Ivermectin Pill DRUG

Ivermecin as a one-time dose

Ivermectin

Placebo DRUG

Inactive medication as a one time dose

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: April 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)