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COVID-19
This section is an excerpt from COVID-19 drug repurposing research § Ivermectin
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In vitro, ivermectin has antiviral effects against several distinct positive-sense single-strand RNA viruses, including SARS-CoV-2.[57] Subsequent studies found that ivermectin could inhibit replication of SARS-CoV-2 in monkey kidney cell culture with an IC50 of 2.2–2.8 μM.[58][59] Based on this information, however, doses much higher than the maximum approved or safely achievable for use in humans would be required for an antiviral effect.[60] Aside from practical difficulties, such high doses are not covered by current human-use approvals of the drug and would be toxic, as the antiviral mechanism of action is considered to operate via the suppression of a host cellular process,[60] specifically the inhibition of nuclear transport by importin α/β1.[61]
In November 2020, a systematic review found weak evidence of benefit when ivermectin is used as an add-on therapy for people with non-severe COVID-19.[62] A randomized controlled trial (RCT) of 24 patients with non-severe COVID-19 and no risk factors found no difference in PCR-positive nasal swabs nor in viral load between patients who received ivermectin and those given placebo, thus failing the primary outcome of the study.[63] Merck, the company from which the drug originated, has said that there is no good evidence ivermectin is plausible or effective as a drug used against COVID-19, and that attempting such use may be unsafe.[64]
As of January 2021, the U.S. National Institutes of Health COVID-19 Treatment Guidelines state that the evidence for ivermectin is too limited to allow for a recommendation for or against its use.[65] Ivermectin is not approved by the U.S. Food and Drug Administration (FDA) for anti-viral use.[65] Additional evidence from RCTs and dose-response studies are needed.[66] At least 45 such trials were listed as of January 2021.[63]
It was reported in June 2020 that despite the absence of high-quality evidence to suggest any efficacy, use of ivermectin for prevention or treatment of early-stage COVID-19 has become increasingly widespread especially in Latin America, raising concerns about self-medication, safety, and the feasibility of future clinical trials.[67][68] In response, the Brazilian Health Regulatory Agency, Brazilian Society of Infectious Diseases, and Brazilian Thoracic Society all issued position statements in July[69] or January 2021[70][71] advising against the use of ivermectin for this purpose. Furthermore, the government of Peru rescinded a previous recommendation for the use of ivermectin (alongside azithromycin and hydroxychloroquine) in hospitalized patients,[72] although as of January 2021 it is still prescribed for outpatient use.[73]
In March 2021, both the FDA and the European Medicines Agency (EMA) issued guidance that ivermectin should not be used to treat or prevent COVID-19.[74][75] After reviewing the evidence on ivermectin the EMA said that "the available data do not support its use for COVID-19 outside well-designed clinical trials".[75] Ivermectin is not authorized for use to treat COVID-19 within the European Union.[75] In the United Kingdom the national COVID-19 Therapeutics Advisory Panel determined that the evidence base and plausibility of ivermectin as a COVID-19 treatment were insufficient to pursue further investigations.[76] The WHO say that ivermectin should not be used to treat COVID-19 except in a clinical trial.[77]