Mexican Federal Government Commences Ivermectin Clinical Trials Targeting COVID-19

May 23, 2020 | Coronavirus, COVID-19, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Ivermectin, Mexico, SARS-CoV-2

Mexican Federal Government Commences Ivermectin Clinical Trials Targeting COVID-19

Mexico’s Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado represents the federal government’s Civil Service Social Security and Services Institute, a federal organization in that nation of 126 million that administers part of the country’s health care and social security systems as well as provide assistance in the areas of disability, aging, and other social services. Known as the ISSSTE, this federal institution covers federal government workers. ISSSTE recently disclosed a small ongoing clinical trial investigating the efficacy of Ivermectin-Azithromycin-Cholecalciferol (Vitamin D) combination in early stages of COVID-19 with outpatient management.

A Major Economy

With 126 million, Mexico has been hit with 62,000 known SARS-CoV-2 cases, along with 6,989 deaths as of this writing. With a recent spike of the disease, the country must push to reopen its fragile economy. Being the 15th largest GDP worldwide, it is the 10th most populous. With enormous potential and growing industry, the country has been ravaged by cartel-driven drug wars and a government known to struggle with significant pockets of corruption. A progressing and reforming Mexico would lead to an absolute renaissance in the North American economy.

Hence the importance of health overall and the pressures for a balanced reopening, despite some turbulence, while establishing policies and procedures that facilitate safety. The government has implemented a number of COVID-19 educational programs, such as social distancing educational programs, especially for rural areas with limited or no internet connections.

ISSSTE is one of the federal government’s important health services providers in the overall fragmented Mexican health care system—the system has over 12 million beneficiaries of public sector employees (active or retired) and their family members.

The Study

This ISSSTE-sponsored study seeks to assess the efficacy of the Ivermectin-Azithromycin-Cholecalciferol combination in early stages of COVID-19 with outpatient management. Once participants provide written informed consent, the sponsors will enroll 30 COVID-19 cases that meet the study’s eligibility requirements—with a 3:1 proportion divided into two groups. 

The first group shall be treated with ivermectin (6mg once daily in days 0, 1, 7, and 8) plus Azithromycin (500mg once daily for four days) and Cholecalciferol (400 IU twice daily for 30 days) in an outpatient regimen. The second group who refused treatment shall be allocated as a control group for monitoring.

The sponsors will test for the virus on days 1 and 14 from the beginning of the clinical trial. Clinical systems under monitor every day of the study include oxygen saturation and oxygenation index. To participate, patients must have a confirmed SARS-CoV-2 infection, respiratory symptoms, cough, fever (T>38 °C), and no drug allergies.

The study started March 15 and runs till June 10, 2020. The study’s principal investigator, Guadalupe Espitia Hernandez, MD, PhD, is associated with Universidad Autonoma del Estado de Hidalgo or The Autonomous University of the State of Hidalgo, a public university located in Pachuca, the capital of the State of Hidalgo, in east-central Mexico.

Primary & Secondary Outcome Measures

First and foremost, Dr. Hernandez and the team will measure viral clearance within a 14-day time frame. Secondly, they will assess 1) duration of symptoms, 2) oxygen saturation, and 3) oxygen saturation (spO2)/fraction of inspired oxygen (FiO2) ration.

The Sponsor

Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado represents the federal government’s Civil Service Social Security and Services Institute, a federal organization that administers part of the country’s health care and social security systems as well as provides assistance in the areas of disability, aging, and other social services. Known as the ISSSTE, this federal institution covers federal government workers. It falls under the Secretariat of Health. The agency was founded in 1959 by President Adolfo Lopez Mateos as part of a kind of war on poverty at the time. The agency has been subject to several criticisms and allegations ranging from corruption to urban bias dominated by certain labor unions. Regardless, with 126 million people, Mexico is the world’s 10th most populous country with a massive federal bureaucracy—the ISSSTE must care for a large number of federal employees. ISSSTE is one of the federal government’s important health services providers in what is an overall fragmented Mexican health care system—the system covers more than 12 million beneficiaries of public sector employees (active or retired) and their family members.

Lead Research/Investigator

Guadalupe Espitia Hernandez, MD, PhD, is associated with Universidad Autonoma del Estado de Hidalgo.

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2 Comments

  1. bh

    Well at least the FDA has not killed Ivermectin yet. They will as soon as their big Pharma friend Gilead sees it as a threat to their Remdesivir. No money to be made off Ivermectin. Lots of money to be made of Remdesivir.

    • John Lipovsky

      Big Pharma has lots of money and lobbyists. FDA is not immune.