A study of patients at high risk of severe COVID-19 disease progression found ivermectin was no more effective than standard care at preventing adverse outcomes.
COVID-19 mRNA vaccination protects against COVID-19 hospitalization and death, but investigators are still looking for other treatments for patients who experience severe disease.
Ivermectin is an inexpensive and widely accessible antiparasitic drug that has been frequently discussed as a potential COVID-19 treatment. However, because there is little data available on its efficacy, one study, published today in JAMA Internal Medicine, tested whether adding ivermectin to the standard of care reduced the risk of severe disease in immunocompromised COVID-19 patients.
The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was conducted at 20 Malaysian public hospitals from May 31-October 25, 2021. The open-label, randomized clinical trial enrolled patients within 1 week of COVID-19 symptom onset. The participants were 50 years of age and older, with comorbidities and confirmed mild-to-moderate COVID-19.
The participants received either oral ivermectin 0.4 mg/kg body weight daily for 5 days in addition to standard of care (n=241) or just standard of care (n-249). The study’s standard of care included symptomatic therapy and monitoring for signs of worsening condition, as based upon laboratory tests, clinical findings, and chest imaging.
The primary study endpoint was the proportion of patients who developed severe disease, as defined by reaching hypoxic stage and requiring supplemental oxygen to stabilize pulse oximetry oxygen saturation above 95%. Secondary trial outcomes included rates of mechanical ventilation and intensive care unit (ICU) admission, 18-day in-hospital mortality, and adverse events.
The study included 490 patients, 54.5% of whom were women, with an average age of 62.5 years. In the ivermectin group, 21.6% of patients (n=52) developed severe disease, compared to 17.3% (n=43) of the control group. There was no significant difference between the 2 groups for all the other secondary trial outcomes.
Though other studies found ivermectin reduced the risk of hospitalization, the investigators noted, “the patients in our trial were hospitalized, which permitted the observed administration of ivermectin with a high adherence rate. Furthermore, we used clearly defined criteria for ascertaining progression to severe disease.”
Among the high-risk cohort with comorbidities, ivermectin as a treatment during early COVID-19 infection did not prevent severe disease progression.