Situated in Jesus Maria, a city in the central Mexican state of Aguascalientes, a health provider called Centenario Hospital Miguel Hidalgo launched a Phase III clinical trial investigating the safety and efficacy of a treatment including hydroxychloroquine and ivermectin for serious COVID-19 infections in non-critical hospitalized patients. Yet another major Mexican health provider to investigate ivermectin as a potential treatment for SARS-CoV-2, the virus behind the COVID-19 pandemic. In this case, the Mexican investigation seeks to test both the anti-malaria drug (precluding those with cardiovascular risk) and the anti-parasitic drug that is increasingly used by doctors from Bangladesh to Bolivia to address COVID-19.
The sponsor, a hospital in central Mexico, seeks to investigate the safety and efficacy of a treatment involving hydroxychloroquine and ivermectin for serious COVID-19 infections in non-critical hospitalized patients.
Prior to any patient randomization the investigational team will assess cardiovascular complications determined by corrected QT interval, related to hydroxychloroquine intake is assessed. For example, if a patient is at high risk, they will be placed in an ivermectin group only or to placebo in an independent randomization; if the risk is low any of the three groups delineated below could be assigned.
Group 1 patients are randomized to receive a 400mg dose of hydroxychloroquine every 12 hours for one day and then 200 mg every 12 hours to complete a 5-day treatment schedule. Meanwhile, Group 2 patients will receive 12 mg of ivermectin every 24 hours for one day (less than 80kg) or ivermectin 18 mg every 24 hours for one day (greater than 80 kg) plus the placebo until the fifth day. Group 3 patients will receive a placebo.
The study team will assess key outcomes including first and foremost successful discharge from the hospital for improvement. The safety outcomes include the requirement of mechanical intubation, septic shock or death. The investigators will assess viral clearance by means of PCR (a standard test) which will be taken on the 5th day after admission, day 14 and day 21.
Jose Manuel Arreola Guerra, MD, MSc, PhD
Mario Gonzalez Gamez, MD, principal investigator
Lucilla Martinez, MD, PhD, sub-investigator
Victor Monroy, MD, sub-investigator