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

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ClinicalTrials.gov Identifier: NCT04527211
Recruitment Status : Not yet recruiting
First Posted : August 26, 2020
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Eduar d. Echeverri, Javeriana University

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE August 26, 2020
Last Update Posted Date August 26, 2020
Estimated Study Start Date  ICMJE September 7, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
Clinical development of covid-19 disease during the intervention period [ Time Frame: 8 weeks ]
Development of of the disease according to the definitions of cases found in the guidelines from the Colombian National Institute of Health
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Seroconversion [ Time Frame: 8 weeks ]
    Indicate if the patient had positive serological antibodies at the end of the study
  • Hospitalization requirement [ Time Frame: 8 weeks ]
    Need for hospitalization independent of the level of complexity due to covid-19
  • Intensive Care Unit Requirement [ Time Frame: 8 weeks ]
    ICU need due to Covid-19
  • Safety of the intervention [ Time Frame: 8 weeks ]
    Adverse effect due to medication or placebo
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Simple randomization will be done with a random number generator and masking will be maintained by concealing the allocation with opaque envelopes. The active medicine as the control will have the same presentation, color and taste, it will be differentiated by a pre-established code from the maker. This will maintain the concealment of patients, caregivers and evaluators. At the central level, only an intervention safety coordinator will know the assignment of each patient in case serious adverse events occur and the concealment needs to be lifted. The outcomes of interest will be obtained from the clinical history of the patients and through direct measurement in the follow-up visits.
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • Healthcare Worker Patient Transmission
Intervention  ICMJE Drug: Ivermectin
Oral administration of ivermectin 200 mcg/kg every week for seven weeks
Study Arms  ICMJE
  • Experimental: Ivermectin
    Oral administration of ivermectin 200 mcg/kg every week for seven weeks
    Intervention: Drug: Ivermectin
  • Placebo Comparator: Placebo
    Oral administration of placebo of similar characteristics every week for seven weeks
    Intervention: Drug: Ivermectin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2020)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 16, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eduar D. Echeverri, Dr. +57 3004634032 echeverri.eduar@javeriana.edu.co
Contact: Julian Santaella, PhD +57 3167401868 juliansantaella@javeriana.edu.co
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04527211
Other Study ID Numbers  ICMJE Epi1JaveCali
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eduar d. Echeverri, Javeriana University
Study Sponsor  ICMJE Javeriana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduar D. Echeverri, Dr. Pontificia Universidad Javeriana
PRS Account Javeriana University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP