Since the onset of the disease, more than 40.5 million people have been diagnosed with
COVID-19 and nearly 1.2 million people have died (October 21, 2020). There is no complete
understanding of the pathogenesis of SARS-CoV-2 infection and to this day there is no
specific therapy or vaccine available. Thus, patient care is based on symptomatic therapy and
treatment of complications.
Ivermectin has been used for more than 30 years for the treatment of several diseases. More
than one million doses of the drug are administered daily, particularly in low- and
middle-income countries. Due to the low prevalence of adverse events with the use of this
drug, ivermectin is considered to have a good safety profile and its potential benefit in
other diseases is currently under investigation.
An in vitro study of ivermectin in SARS-CoV-2 in Australia showed a significant reduction of
viral load in infected cells. Subsequently, a descriptive study of 704 critical patients with
COVID-19 showed a reduction in mortality, hospitalization, and intensive care unit
length-of-stay in those patients who received the drug. Unfortunately, this study was
withdrawn by its authors, leaving more questions than answers.
Some countries in Latin America have authorized its use for the management of patients with
COVID-19 even in the absence of solid evidence, and several other countries are conducting
clinical trials to evaluate its efficacy for the treatment of moderate and severe disease.
Since there is no specific treatment for COVID-19 and the therapeutic options are scarce, the
researchers believe it is completely plausible, urgent, and necessary to evaluate if
ivermectin use reduces the risk of admission to an intensive care unit (ICU) in hospitalized
adults with severe COVID-19. The proposal is a randomized, double-blind clinical trial,
conducted at CES Clinic, Medellin-Colombia. The investigators will randomize 100 patients
with severe, non-critical illness, into two groups, one group will receive ivermectin in
addition to standard management and the other group will receive placebo plus standard
management. Clinical outcomes to evaluate will be ICU admission, need for mechanical
ventilation, length of hospital stay, days in the ICU and mechanical ventilation, and
finally, the incidence of adverse events related to the intervention. The estimated time to
complete the study is approximately five months.