Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04527211
Study type Interventional
Source Javeriana University
Contact Eduar D. Echeverri, Dr.
Phone +57 3004634032
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date September 7, 2020
Completion date December 16, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT04395768 - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19 Phase 2
Recruiting NCT04555096 - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19 Phase 2
Enrolling by invitation NCT04508777 - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed NCT04506268 - COVID-19 SAFE Enrollment N/A
Recruiting NCT04581915 - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19 Phase 2/Phase 3
Recruiting NCT04546737 - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients N/A
Active, not recruiting NCT04542993 - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy Phase 2
Not yet recruiting NCT04543006 - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19 N/A
Completed NCT04494646 - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19) Phase 2
Completed NCT04532294 - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants Phase 1
Recruiting NCT04387292 - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic N/A
Completed NCT04610502 - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients Phase 2
Recruiting NCT04505774 - Anti-thrombotics for Adults Hospitalized With COVID-19 (ACTIV-4) Phase 4
Active, not recruiting NCT04596839 - Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19) Phase 2
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Not yet recruiting NCT04361032 - Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia Phase 3
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT04338126 - Tranexamic Acid (TXA) and Corona Virus 2019 (COVID19) in Inpatients Phase 2
Recruiting NCT04870307 - Community-engaged Approaches to Testing in Community and Healthcare Settings for Underserved Populations N/A
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3