Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel (IveprofCovid19)

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; Healthcare Worker Patient Transmission
• Intervention / Treatment: Drug: Ivermectin

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Eduar D. Echeverri, Dr.; Phone Number: +57 3004634032; Email: echeverri.eduar@javeriana.edu.co
• Study Contact Backup: Name: Julian Santaella, PhD; Phone Number: +57 3167401868; Email: juliansantaella@javeriana.edu.co

Study Locations

• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760501
      • Pontificia Universidad Javeriana
      • Contact: Eduar d Echeverri, Dr.; Phone Number: 3004634032; Email: dr.echeverri@gmail.com
      • Contact: Julian Santaella, PhD; Phone Number: 3167401868; Email: juliansantaella@javeriana.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ivermectin; Oral administration of ivermectin 200 mcg/kg every week for seven weeks	Drug: Ivermectin; Oral administration of ivermectin 200 mcg/kg every week for seven weeks
Placebo Comparator: Placebo; Oral administration of placebo of similar characteristics every week for seven weeks	Drug: Ivermectin; Oral administration of ivermectin 200 mcg/kg every week for seven weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion	Indicate if the patient had positive serological antibodies at the end of the study	8 weeks
Hospitalization requirement	Need for hospitalization independent of the level of complexity due to covid-19	8 weeks
Intensive Care Unit Requirement	ICU need due to Covid-19	8 weeks
Safety of the intervention	Adverse effect due to medication or placebo	8 weeks

Collaborators and Investigators

• Sponsor: Javeriana University
• Investigators: Principal Investigator: Eduar D. Echeverri, Dr., Pontificia Universidad Javeriana

Study record dates

Study Major Dates

• Study Start (Anticipated): September 7, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): December 16, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; prophylaxis; SARS-CoV2; ivermectin; health workers
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: Epi1JaveCali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No