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

Launched by MINISTRY OF PUBLIC HEALTH, ARGENTINA · May 12, 2021

Keywords

ClinConnect Summary

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=...

Gender

ALL

Eligibility criteria

• 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