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According to a study published in JAMA Today, researchers from the Center for Studies in Pediatric Infectology in Cali, Colombia, analyzed the effect of ivermectin over time to resolution of symptoms in adults with mild COVID-19.
Importance Ivermectin is widely prescribed as a potential treatment for COVID-19 despite uncertainty about its clinical benefit.
Aim Determine if ivermectin is an effective treatment for mild COVID-19.
Design, stage and participants Randomized, double-blind, single-site trial in Cali, Colombia. Potential study participants were identified by simple random sampling from the state department of health electronic database of patients with laboratory-confirmed symptomatic COVID-19 during the study period. A total of 476 adult patients with mild illness and symptoms were enrolled for 7 days or less (at home or hospitalized) between July 15 and November 30, 2020, and followed through December 21, 2020.
Intervention Patients were randomized to receive ivermectin, 300 μg / kg of body weight per day for 5 days (n = 200), or placebo (n = 200).
Main results and measures The primary outcome was time to resolution of symptoms within a 21-day follow-up period. Requested adverse events and serious adverse events were also collected.
Results Among the 400 patients who were randomized into the primary analysis population (median age, 37 years [interquartile range {IQR}, 29-48]; 231 women [58%]), 398 (99.5%) completed the test. Median time to resolution of symptoms was 10 days (IQR, 9-13) in the ivermectin group compared to 12 days (IQR, 9-13) in the placebo group (hazard ratio for resolution of symptoms, 1.07 [95% CI, 0.87 to 1.32]; P= .53 by log rank test). By day 21, 82% in the ivermectin group and 79% in the placebo group had resolved their symptoms. The most common solicited adverse event was headache, reported by 104 patients (52%) who received ivermectin and 111 (56%) who received placebo. The most common serious adverse event was multi-organ failure, which occurred in 4 patients (2 in each group).
Conclusion and relevance Among adults with mild COVID-19, a 5-day cycle of ivermectin, compared to placebo, did not significantly improve time to resolution of symptoms. The findings do not support the use of ivermectin for the treatment of mild COVID-19, although larger trials may be necessary to understand the effects of ivermectin on other clinically relevant outcomes.
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