1. Ivermectin treatment did not lower the incidence of medical admission to a hospital due to the progression of Covid-19.
2. Ivermectin treatment did not reduce the length of observation in the emergency department in patients with an early diagnosis of Covid-19.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Identifying inexpensive, widely available, and effective therapies for Covid-19 is important, as major challenges remain regarding vaccine production and allocation. Ivermectin, which is typically used as an antiparasitic drug, has been proposed to have efficacy for the treatment of Covid-19, although previously has been used for the treatment of onchocerciasis, strongyloidiasis, and ectoparasitic infection. Therefore, there is a gap in knowledge as to understanding the efficacy of ivermectin for the prevention of progression of Covid-19 resulting in hospitalization among outpatients with SARS-CoV-2 infection. This study found that administration of ivermectin did not result in a lower incidence of hospitalization or prolonged emergency department observation for Covid-19. This study was limited by potential criticism that the study’s administration regimen was inadequate given the public interest in ivermectin and the support of its use by paramedical groups. Nevertheless, these study’s findings are significant, as they demonstrate that early treatment of Covid-19 patients with ivermectin does not result in a lower incidence of hospital admission or prolonged emergency department observation for patients at high risk for serious illness.
In-Depth [randomized clinical trial]: This double-blind, randomized, placebo-controlled, adaptive platform trial studied Covid-19 positive patients from 12 public health clinics in Brazil. Patients who were 18 years or older, and presented to an outpatient clinic with symptoms of Covid-19, and at least one high-risk criterion for progression of Covid-19 such as diabetes mellitus, hypertension, lung disease, or cardiovascular disease were eligible for the study. Patients who were previously vaccinated against Covid-10 were also eligible for the study. Patients who did not have at least one high-risk criterion for Covid-19 progression were excluded from the study. The primary outcome measured was hospitalization due to Covid-19 within 28 days after randomization or an emergency department visit due to worsening of Covid-19 symptoms within 28 days after randomization. Outcomes in the primary analysis were assessed via an intention-to-treat population and a Bayesian framework. Based on the analysis, this study randomly assigned 3515 patients to receive ivermectin, placebo, or another intervention. Overall, 14.7% of patients in the ivermectin group had a primary outcome event such as hospitalization, while 16.3% of patients in the placebo group had a primary outcome event (relative risk, 0.9; 95% Bayesian credible interval, 0.7 to 1.16). 81% of these primary outcome events consisted of hospital admissions. These findings were similar to a modified intention-to-treat analysis that included patients who received at least one dose of ivermectin or placebo (relative risk, 0.89; 95% Bayesian credible interval, 0.69 to 1.15). In a per-protocol analysis that included patients who were 100% adherent to their assigned regimen, the findings were similar as well, with a relative risk of 0.94 (95% Bayesian credible interval, 0.67 to 1.35). Overall, this study demonstrates that early ivermectin treatment does not significantly reduce the incidence of hospital admission or prolonged emergency department observation for outpatients with an early diagnosis of Covid-19 and at high risk for serious illness or disease progression.
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