Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand.

BACKGROUND: Ivermectin is an antiparasitic drug administered to hundreds of millions of people worldwide. Fundamental research suggests that ivermectin is effective against coronavirus disease 2019 (COVID-19); therefore, we investigated the efficacy and safety of ivermectin as a COVID-19 treatment option. METHODS: This multi-regional (Japan and Thailand), multicenter, placebo-controlled, randomized, double-blind, parallel-group, Phase III study evaluated the efficacy and safety of ivermectin in patients with mild COVID-19 (IVERMILCO Study). The participants took a specified number of the investigational product (ivermectin or placebo) tablets of, adjusted to a dose of 0.3-0.4 mg/kg, orally on an empty stomach once daily for three days. The primary efficacy endpoint was the time at which clinical symptoms first showed an improving trend by 168 h after investigational product administration. RESULTS: A total of 1030 eligible participants were assigned to receive the investigational product; 502 participants received ivermectin and 527 participants received a placebo. The primary efficacy endpoint was approximately 96 h (approximately four days) for both ivermectin and placebo groups, which did not show statistically significant difference (stratified log-rank test, p = 0.61). The incidence of adverse events and adverse drug reactions did not show statistically significant differences between the ivermectin and placebo groups (chi-square test, p = 0.97, p = 0.59). CONCLUSIONS: The results show that ivermectin (0.3-0.4 mg/kg), as a treatment for patients with mild COVID-19, is ineffective; however, its safety has been confirmed for participants, including minor participants of 12 years or older (IVERMILCO Study ClinicalTrials.gov number, NCT05056883.).

Pediatric surgery triage: problems and improvements.

BACKGROUND: The Canadian Paediatric Triage and Acuity Scale (P-CTAS) is used and modified at hospitals as a triage tool for pediatric patients before they are seen in emergency rooms. Pediatric surgery patients account for very few of the many patients in emergency departments, but they should be triaged as emergency or urgent because they might be candidates for surgery. Problems with and improvements for triaging pediatric surgery patients using the P-CTAS were studied. METHODS: This retrospective study evaluated all patients <16 years old who visited the emergency department of Kyorin University Hospital during an approximately 4 year period between 1 May 2005, and 11 February 2009. Pediatric surgery patients were divided into two groups to evaluate the efficiency of P-CTAS triage. Patients who needed emergency treatment were in group A, and the others were in group B. RESULTS: Most group A patients were level I, II, or III (97%, 111/114). In contrast, 60% (71/119) of group B patients were level IV or greater. Some problems with and suggestions for the P-CTAS were identified. Many patients with trauma were under 1 year of age, and many with a foreign body were under 2 years of age. Age categories should be added for patients with trauma or foreign body aspiration. Patients with abdominal pain, and without anal bleeding or vomiting who are >2 years old are triaged as level IV and they accounted for 12% of patients with possible intussusception in this study. A category of 'possible intussusception' should be made for level II. Most patients with acute scrotum, whether operated on or not, were level III. 'Red or purple color of scrotal skin' and/or 'within 6 h from onset' could be added to level II for patients with acute scrotum. CONCLUSIONS: P-CTAS worked well for pediatric surgery patients, and it needs to be modified and improved for such patients based on these results.