Ivermectin for Management of COVID-۱۹ in Iranian Children: Results of Two Randomized, Placebo-controlled Clinical Trials

Background: The global search for effective COVID-۱۹ treatments extended to the use of ivermectin, a drug with potential antiviral properties. However, evidence remains conflicting, especially for children.  Objectives: This study aimed to investigate the efficacy and safety of ivermectin for treating COVID-۱۹ in Iranian children through two independent randomized, placebo-controlled trials.  Methods: Two multicenter, randomized, double-blind, placebo-controlled clinical trials were conducted to evaluate the efficacy of ivermectin in ۱۹۵ children with COVID-۱۹, including ۶۶ inpatients (۳۵ in the ivermectin group and ۳۱ in the placebo group) and ۱۲۹ outpatients (۷۰ in the ivermectin group and ۵۹ in the placebo group). The treatment group received a daily oral dose of ivermectin (۴۰۰ μg/kg/day, ۶ mg tablet) for three consecutive days, while the control group received an identical placebo. The primary outcome was disease prognosis. The secondary outcomes for inpatients included duration of hospitalization, need for pediatric intensive care unit (PICU) admission, need for oxygen, adverse events, and mortality. For outpatients, secondary outcomes were need for hospitalization, need for PICU admission, viral clearance, adverse events, and mortality. Results: All inpatients in both ivermectin and placebo groups fully recovered from COVID-۱۹. Among outpatients, ۹۸.۶% recovered after ivermectin use, and ۱۰۰% recovered with placebo. A significant difference was found in the need for PICU admission among inpatients (۲.۸% in the ivermectin group and ۲۵.۸% in the placebo group; P=۰.۰۱۰). Additionally, viral clearance differed significantly, with more patients in the ivermectin group testing negative for COVID-۱۹ on day six than in the placebo group (P=۰.۰۴۲). The length of hospital stay was similar for both groups.  Conclusions: Although ivermectin can reduce the need for PICU admission among inpatient children with COVID-۱۹, it did not improve overall clinical recovery or length of hospital stay. For outpatients, ivermectin does not enhance recovery or reduce the need for hospitalization but showed promising viral clearance effects. Considering all aspects, the use of ivermectin in the treatment of children with COVID-۱۹ cannot be recommended.

کلیدواژه ها:

Ivermectin ، COVID-۱۹ ، Children ، Clinical trial