Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel

• Status: Not yet recruiting
• Trial end date: 2020-12-16
• Target enrollment: 0
• Participant gender: All

Summary

It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the effectiveness and safety of the administration to of ivermectin at a dose of 200 mcg/kg once a week for 7 weeks in a prophylactic treatment against SARS COV-2 infection in 550 Colombian health workers during the COVID-19 pandemic.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Javeriana University
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

• Subjects over 18 years old of any sex who work as health care workers, laboriously active during the recruitment of the study in health services that do not screen for the exclusion of acutely ill patients.

• Subjects who have not presented general symptoms such as general discomfort, fever, cough, dyspnoea or muscle pain in the last week.

• Subjects with negative COVID-19 serological antibody diagnostic tests.

Exclusion Criteria:

• Subjects considered as a resolved case of COVID-19 infection, according to guidelines from the Colombian National Institute of Health.

• Health personnel with social distancing due to close contact without personal protective equipment with confirmed patients of infection, or who are taking any medication as possible prophylaxis for COVID-19 (example; chloroquine, hydroxychloroquine, azithromycin)

• Health workers who have permits or temporary withdrawal from their hospital work for more than one week during the first month of the study.

• Subjects with known allergy to ivermectin.

• Women in a state of pregnancy or lactation.

• |Subjects with a body mass index less than 18.5 and greater than 35.