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Early administration of the antiparasitic drug ivermectin did not significantly reduce the time to clinical improvement in 400 adults with mild COVID-19, a clinical trial JAMA find.
Led by researchers at the Centro de Estudios en Infectologia Pediatrica in Cali, Colombia, the single-center, double-blind randomized trial used a random sample of coronavirus-positive patients to identify inpatients and outpatients with mild COVID-19 during of the first 7 days. after the onset of symptoms from July 15 to November 30, 2020.
The median time to symptom resolution was 10 days in the 200 patients randomized to receive ivermectin daily for 5 days, compared to 12 days in 198 patients receiving placebo (interquartile range for both, 9 to 13 days; report of risk, 1.07).
Twenty-one days after starting treatment, 82% in the ivermectin group and 79% receiving placebo were symptom-free. Only 2% of patients in the ivermectin group and 3.5% in the placebo group experienced clinical deterioration of at least two points on an ordinal eight point scale (absolute difference, -1.53). The odds ratio for clinical deterioration in people receiving ivermectin versus placebo was 0.56.
Escalation of care, fever
There was no significant difference between the two groups in the proportion of patients requiring more aggressive care (2% who received ivermectin vs. 5% who received placebo; absolute difference, -3.05) or in the length of time intensive care was required. (median difference, 7 days).
There were also no significant differences in the proportions of febrile patients (absolute difference between ivermectin and placebo, -2.61) or in the duration of fever (absolute difference, -0.5 days). . Ivermectin did not reduce emergency room visits or telemedicine.
Seventy-seven percent of the ivermectin group and 81.3% of the placebo group had adverse events, 7.5% of the first group and 2.5% of the last group stopping treatment as a result. The most common adverse reaction was headache (52% in the ivermectin group, 56% in the placebo group). Other symptoms included coughing and changes in smell and taste.
Two patients in each group developed multi-organ failure, making this the most common serious adverse event, although neither case was considered to be treatment-related. One patient who received a placebo died.
The median age of the participants was 37 years, 58% were female, 58.3% were ambulatory patients, and 79% had no known underlying medical conditions.
Lack of strong evidence of use
Cumulatively, the results suggest that ivermectin does not significantly affect the course of early COVID-19, which is consistent with pharmacokinetic models showing that plasma levels of total and unbound ivermectin do not reach the concentration resulting in 50% viral inhibition even at a dose level 10 – times higher than the approved dose, ”the authors concluded.
“The results do not support the use of ivermectin for the treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes.”
Laboratory and animal studies have suggested that ivermectin has activity against SARS-CoV-2, the virus that causes COVID-19, the authors noted, adding that the drug showed signs of antiviral activity. at the start of other types of infections. As a result, some countries have included the drug in their coronavirus treatment guidelines, taxing supplies early in the pandemic, despite the lack of studies in clinical trials.
“To our knowledge, preliminary reports of other randomized trials of ivermectin as a treatment for COVID-19 with positive results have not yet been published in peer-reviewed journals,” the researchers wrote.
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