tetano
Editor, Senior Moderator
J Infect Chemother
. 2023 Dec 26:S1341-321X(23)00316-1.
doi: 10.1016/j.jiac.2023.12.012. Online ahead of print. Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand
Hiroshige Mikamo[SUP] 1 [/SUP], Satoshi Takahashi[SUP] 2 [/SUP], Yuka Yamagishi[SUP] 3 [/SUP], Akihiro Hirakawa[SUP] 4 [/SUP], Toshiyuki Harada[SUP] 5 [/SUP], Hirotaka Nagashima[SUP] 6 [/SUP], Chiaki Noguchi[SUP] 7 [/SUP], Kentaro Masuko[SUP] 8 [/SUP], Hiromitsu Maekawa[SUP] 9 [/SUP], Tatsuhiko Kashii[SUP] 10 [/SUP], Hiroyuki Ohbayashi[SUP] 11 [/SUP], Shinichiro Hosokawa[SUP] 12 [/SUP], Katsuyuki Maejima[SUP] 13 [/SUP], Masaya Yamato[SUP] 14 [/SUP], Weerawat Manosuthi[SUP] 15 [/SUP], Supachai Paiboonpol[SUP] 16 [/SUP], Hideki Suganami[SUP] 17 [/SUP], Ryohei Tanigawa[SUP] 18 [/SUP], Hitoshi Kawamura[SUP] 19 [/SUP]; IVERMILCO Study Group
Affiliations
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.).
Keywords: COVID-19; Clinical trial; Drug repositioning; Ivermectin; Randomized controlled trial; SARS-CoV-2.
. 2023 Dec 26:S1341-321X(23)00316-1.
doi: 10.1016/j.jiac.2023.12.012. Online ahead of print. Efficacy and safety of ivermectin in patients with mild COVID-19 in Japan and Thailand
Hiroshige Mikamo[SUP] 1 [/SUP], Satoshi Takahashi[SUP] 2 [/SUP], Yuka Yamagishi[SUP] 3 [/SUP], Akihiro Hirakawa[SUP] 4 [/SUP], Toshiyuki Harada[SUP] 5 [/SUP], Hirotaka Nagashima[SUP] 6 [/SUP], Chiaki Noguchi[SUP] 7 [/SUP], Kentaro Masuko[SUP] 8 [/SUP], Hiromitsu Maekawa[SUP] 9 [/SUP], Tatsuhiko Kashii[SUP] 10 [/SUP], Hiroyuki Ohbayashi[SUP] 11 [/SUP], Shinichiro Hosokawa[SUP] 12 [/SUP], Katsuyuki Maejima[SUP] 13 [/SUP], Masaya Yamato[SUP] 14 [/SUP], Weerawat Manosuthi[SUP] 15 [/SUP], Supachai Paiboonpol[SUP] 16 [/SUP], Hideki Suganami[SUP] 17 [/SUP], Ryohei Tanigawa[SUP] 18 [/SUP], Hitoshi Kawamura[SUP] 19 [/SUP]; IVERMILCO Study Group
Affiliations
- PMID: 38154616
- DOI: 10.1016/j.jiac.2023.12.012
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.).
Keywords: COVID-19; Clinical trial; Drug repositioning; Ivermectin; Randomized controlled trial; SARS-CoV-2.