Use of ivermectin for the treatment of patients with COVID-19

INTRODUCTION: Since the declaration of the pandemic by COVID-19, various drugs have been proposed to treat this disease. One of these drugs is ivermectin, an antiparasitic that has shown positive effects in vitro and that has received the attention of various health professionals as a possible treatment for patients with COVID-19 in recent weeks. On April 9, the IETSI published a brief report in which it concluded that, until then, the evidence was limited to an in vitro effect on virus replication. As more studies were lacking before being evaluated in humans, it was not possible to make a recommendation in favor of the use of ivermectin in the treatment of patients with COVID-19. METHODOLOGY: this brief report was updated. For this update, a bibliographic search of systematic reviews (SR), randomized clinical trials (RCTs) and observational studies in PubMed (https://www.ncbi.nlm.nih.gov/pubmed/) and Embase (https: / /www.embase.com/). RESULTS: Two studies on the pharmacokinetics of ivermectin, one observational study and seven clinical trials on the use of ivermectin in the treatment of patients with COVID-19, registered on the website of the National Institutes of Health (NIH) of the United States, were identified. (www.clinicaltrials.gov) and two communications made by the FDA. ANALYSIS: Since the last update, April 9, to date, May 08, only three new publications (in preprint) were identified: two pharmacokinetic studies and one observational study in humans. The two pharmacokinetic studies aimed to estimate the doses of ivermectin to be used in humans; so that the IC50 necessary to observe the inhibitory effect on SARS-CoV-2 is reached, as published by Caly et al (Caly et al. 2020). Both studies reported that according to the available pharmacokinetic information, the currently authorized doses of ivermectin would produce IC50 values ​​well below the IC50 required to observe the inhibitory effect reported by Caly et al (Caly et al. 2020). In other words, using the currently authorized doses of ivermectin, no results would be observed in patients with COVID-19. An alternative to this problem would be to increase the dose of ivermectin; however, treatment of patients with COVID 19 using ivermectin would require doses that are well above those authorized and for which no safety information is available. These results indicate that more studies are required before ivermectin can be considered as an alternative for the treatment of patients with COVID-19. CONCLUSION: Due to the limited evidence available to date (May 8, 2020), the IETSI maintains the conclusion expressed in the previous version of this brief report that it is not possible to support a recommendation in favor of the use of ivermectin in patients with COVID-19. The evidence on the viability of ivermectin as a COVID-19 treatment is still in the early stages of development; highlighting that pharmacokinetic predictions are theoretical and evidence from human studies is sparse and observational. For all the reasons expressed herein, it is recommended that the use of ivermectin be restricted to use in clinical trials. And you should be alert to the results of clinical trials currently underway.