Back to Search
Start Over
Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand.
- Source :
-
Journal of Infection & Chemotherapy (Elsevier Inc.) . Jun2024, Vol. 30 Issue 6, p536-543. 8p. - Publication Year :
- 2024
-
Abstract
- 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. 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. 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). 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.). [ABSTRACT FROM AUTHOR]
- Subjects :
- *COVID-19
*PATIENT safety
*DRUG side effects
*COVID-19 treatment
*IVERMECTIN
Subjects
Details
- Language :
- English
- ISSN :
- 1341321X
- Volume :
- 30
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Journal of Infection & Chemotherapy (Elsevier Inc.)
- Publication Type :
- Academic Journal
- Accession number :
- 176648401
- Full Text :
- https://doi.org/10.1016/j.jiac.2023.12.012