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

Covid19 Clinical Trial

— IveprofCovid19  

Official title:

Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel at All Levels of Care, During the 2020 Pandemic: A Randomized Clinical Controled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527211
• Other study ID #: Epi1JaveCali
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 7, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: August 2020
• Source: Javeriana University
• Contact: Eduar D. Echeverri, Dr.
• Phone: +57 3004634032
• Email: echeverri.eduar[@]javeriana.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Introduction: In less than four months, an outbreak of severe pneumonia, initially identified in Wuhan (China), has spread to more than 185 countries and territories, leaving more than 1,835,000 people compromised and 113,362 deaths, according to statistics provided by Johns Hopkins University (1). Additionally, this outbreak has collapsed health systems in some countries and has begun to have a huge impact on the global economy.

The etiological agent, an RNA virus of the Coronaviridae family called SARS COV-2, is characterized by having a high contagion index (R0 = 1, 4 - 5, 5) (2), high virulence and lethality rates that can go up to 10% in some populations. The contagion of health workers has led to the loss of subjects with high social value to face the pandemic further weakening health systems. Because it is necessary to wait several months for the development, testing, approval and commercialization of a SARS COV-2 vaccine, there has been an urgent need to identify drugs that can offer a prophylactic effect for health workers who have high risk of being infected with the virus.

Recently, the in vitro antiviral effect of ivermectin was described to inhibit the invasive cellular action of SARS COV-2 (3), an effect explained by the HTA (Host Target Antivirals) model. Given the known safety and effectiveness of ivermectin in the treatment of parasitic infections in humans, this drug could be used prophylactically in health workers if the effects described on in-vitro studies are also present on in-vivo scenarios. However, so far, no study has shown the antiviral effects that ivermectin could have against SARS COV-2 or its effectiveness in reducing health complications caused by this virus in humans.

Objective: To determine the effectiveness and safety of the administration 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 Colombian health workers during the COVID-19 pandemic.

Methods: It will be performed a randomized, multicenter, triple-masked, placebo-controlled clinical experiment to determine the relative risk of SARS COV-2 infection, seroconversion, and clinically presenting disease. In addition, the relative risk of requiring hospitalization or entering the intensive care unit was evaluated in doctors, nurses, respiratory therapists and assistants who have direct contact with patients with COVID-19. After being exposed to ivermectin prophylaxis or placebo for seven weeks, the results will be measured at eight weeks, with interim analyses to monitor the safety of the participating subjects.

Keywords: Coronavirus 2019, COVID-19, SARS-CoV2, ivermectin, prophylaxis, treatment, health workers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 550
• Est. completion date: December 16, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Healthcare Worker Patient Transmission
• Infection

Intervention

Drug:
• Ivermectin
Oral administration of ivermectin 200 mcg/kg every week for seven weeks

Locations

Country	Name	City	State
Colombia	Pontificia Universidad Javeriana	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Javeriana University

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical development of covid-19 disease during the intervention period	Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of Health	8 weeks
Secondary	Seroconversion	Indicate if the patient had positive serological antibodies at the end of the study	8 weeks
Secondary	Hospitalization requirement	Need for hospitalization independent of the level of complexity due to covid-19	8 weeks
Secondary	Intensive Care Unit Requirement	ICU need due to Covid-19	8 weeks
Secondary	Safety of the intervention	Adverse effect due to medication or placebo	8 weeks