europeanpharmaceuticalreviewMarch 08, 2021
Tag: Ivermectin , COVID-19 , Clinical Trial
In a randomised trial of 476 patients with mild COVID-19, a five-day course of ivermectin did not significantly improve the time to resolution of symptoms and therefore the investigators concluded that the trial does not support the use of ivermectin for treatment of mild COVID-19.
Ivermectin is a broad-spectrum antiparasitic drug. It is also known to have antiviral properties and was shown to have some activity against SARS-CoV-2 (the virus that causes COVID-19) in vitro and in vivo. As its safety profile is well characterised, ivermectin has therefore garnered a lot of interest from scientists and policy makers with regards to its potential use against COVID-19. In fact, several countries have included ivermectin in their treatment guidelines.
However, according to the investigators, clinical trials are needed to determine the effects of ivermectin on COVID-19 in the clinical setting. They therefore set up a trial to ascertain whether ivermectin has any beneficial effect on duration of symptoms in adults with mild COVID-19.
The double-blind randomised study (NCT04405843) enrolled a total of 476 adult patients with mild disease and symptoms for less than days (at home or hospitalised). The participants were randomised 1:1 to receive either ivermectin at a dose of 300μg/kg of body weight per day or placebo. The primary outcome was time to resolution of symptoms within a 21-day follow-up period, adverse events associated with the treatment were also assessed.
The primary analysis includes 398 people who completed the trial. According to the investigators, the median time to resolution of symptoms was 10 days in the ivermectin group compared with 12 days in the placebo group. By day 21, 82 percent in the ivermectin group and 79 percent in the placebo group had resolved symptoms. The most common solicited adverse event was headache, reported by 52 percent of those given ivermectin (104 patients) and 56 percent of people receiving placebo (111 participants) who received placebo. The most common serious adverse event was multiorgan failure, occurring in two patients in each group (four total).
From this analysis the researchers concluded that while larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes, the drug does not significantly improve the time to resolution of mild symptoms of COVID-19.
The results were published in JAMA.
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