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

NCT04527211 | Unknown Phase 3 DMC

• 1 other identifier: Epi1JaveCali
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Healthcare Worker Patient Transmission

Keywords

prophylaxis; ivermectin; COVID-19; health workers; SARS-CoV2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Seroconversion

  8 weeks

• Hospitalization requirement

  8 weeks

• Intensive Care Unit Requirement

  8 weeks

• Safety of the intervention

  8 weeks

Study Arms (2)

Ivermectin

EXPERIMENTAL

Oral administration of ivermectin 200 mcg/kg every week for seven weeks

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

Oral administration of placebo of similar characteristics every week for seven weeks

Drug: Ivermectin

Interventions

Ivermectin DRUG

Oral administration of ivermectin 200 mcg/kg every week for seven weeks

Ivermectin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Javeriana University: lead

Study Sites (1)

Pontificia Universidad Javeriana

Cali, Valle del Cauca Department, 760501, Colombia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Eduar D. Echeverri, Dr.

  Pontificia Universidad Javeriana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduar D. Echeverri, Dr.

CONTACT

+57 3004634032; echeverri.eduar@javeriana.edu.co

Julian Santaella, PhD

CONTACT

+57 3167401868; juliansantaella@javeriana.edu.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Spec. and Clinical Epidemiologist

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: September 7, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 16, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)