Prophylaxis for COVID-19: Ivermectin in Close Contacts of COVID-19 Cases (IVERNEX-TUC) (IVERNEX-TUC)

December 1, 2021 updated by: Maria de los Angeles Peral de Bruno, Ministry of Public Health, Argentina

Study of Efficacy and Safety of Ivermectin for COVID-19 Prophylaxis in Post-exposure Contact or Epidemiological Link

Randomized controlled clinical trial on using oral ivermectin in COVID-19 prophylaxis supplying the drug to close contacts of confirmed cases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, and controlled clinical trial that aims to evaluate the use of oral ivermectin in COVID-19 prophylaxis. The study has two arms in a relationship of 2:1: Experimental Group (EG n=500) and Placebo Group (CG n=250).

The sample size was calculated by applying a two-proportion comparison test. Type of two-sided test, 95% confidence or safety level (1-α), 95% statistical power, 75% P1 (proportion in the placebo group), 65% P2 (proportion in the new treatment or intervention group), size sample without adjustment (n = 543), 25% expected proportion of losses, n= 724 sample adjusted for losses.

The hypothesis of the study is that treatment with ivermectin may decrease the chance of occurrence/progress of clinical manifestations and onset of severe disease. Whereas control of the contagion on the first days of development of the disease, this treatment with ivermectin in suspected cases of COVID-19 (by epidemiological nexus) would contribute to the control of contagion at the first part of the infection, even in the absence of symptoms.

Categorical variables will be represented with frequencies and proportions, while continuous quantitative variables will be expressed as mean ± standard deviation (SD) or as median and interquartile range (IQR). The proportions will be compared using Pearson's Chi-square test or Fisher's exact test as appropriate, and continuous quantitative variables with Student's t test. The estimation of the efficacy of intensive treatment with Ivermectin will be calculated using Kaplan-Meier curves and the differences will be analyzed by means of the log-rank test. The risk will be calculated as a ratio of advantages for Intensive treatment with Ivermectin (Odds Ratio, OR) with its 95% confidence intervals (95% CI). A value of p <0.05 will be considered significant. Analyzes will be performed using Stata 11.2 software.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Tucumán, Argentina, 4000
        • SI.PRO.SA, Ministerio de Salud Pública

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Over 18 years either sex
  • Women of childbearing age with a negative pregnancy test
  • In close contact group or epidemiological nexus of a positive COVID-19 case
  • Able to understand and grant informed consent
  • Real-time - polymerase chain reaction test with a negative result

Exclusion Criteria:

  • Known hypersensitivity or allergy to any component of the drug under evaluation
  • Age under 18 years
  • Use of immunosuppressants (including systemic corticosteroids) in the last 30 days
  • Pregnant or lactating
  • Patients with other acute infectious diseases
  • Patients with autoimmune disease and/or chronic decompensated diseases
  • Who have received a vaccine for COVID-19 (1/2 dose) or that have taken ivermectin (prior to 30 days of the study) or who are participating in another COVID-19 prophylaxis study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The EG receives ivermectin 0,6mg/kg of weight orally on days 1 (one) and 7 (seven) plus standard biosecurity care
Drug: Ivermectin
0,6mg/kg of weight orally on days 1 and 7
Other Names:
  • Iver
Placebo Comparator: Control Group
The CG receives a placebo on days 1 (one) and 7 (seven) plus standard biosecurity care
Other: Placebo
A substance with similar physical characteristics as ivermectin, without the active drug ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects who were diagnosed with COVID-19 in EG and CG (Negative polymerase chain reaction - real-time).
Time Frame: At 2 weeks
Pearson's Chi-square and proportion test
At 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contagion risk.
Time Frame: Up to 2 weeks
Odd Ratio
Up to 2 weeks
Prophylactic effect associated with patient's preexisting comorbidity
Time Frame: Up to 2 weeks
Logistic regression test
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Public Health, Argentina

Investigators

  • Principal Investigator: Rossana Chahla, Ph. D, Ministry of Public Health, Tucumán, Argentina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5077/410 CH 2020

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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