AUTHOR=Wada Tatsuhiko , Hibino Makoto , Aono Hiromi , Kyoda Shunsuke , Iwadate Yosuke , Shishido Eri , Ikeda Keisuke , Kinoshita Nana , Matsuda Yasuki , Otani Sakiko , Kameda Ryo , Matoba Kenta , Nonaka Miwa , Maeda Mika , Kumagai Yuji , Ako Junya , Shichiri Masayoshi , Naoki Katsuhiko , Katagiri Masato , Takaso Masashi , Iwamura Masatsugu , Katayama Kazuhiko , Miyatsuka Takeshi , Orihashi Yasushi , Yamaoka Kunihiro , for the CORVETTE-01 Study Group TITLE=Efficacy and safety of single-dose ivermectin in mild-to-moderate COVID-19: the double-blind, randomized, placebo-controlled CORVETTE-01 trial JOURNAL=Frontiers in Medicine VOLUME=10 YEAR=2023 URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1139046 DOI=10.3389/fmed.2023.1139046 ISSN=2296-858X ABSTRACT=Background

To investigate whether ivermectin inhibits SARS-CoV-2 proliferation in patients with mild-to-moderate COVID-19 using time to a negative COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) test.

Methods

CORVETTE-01 was a double-blind, randomized, placebo-controlled study (August 2020–October 2021) conducted in Japan. Overall, 248 patients diagnosed with COVID-19 using RT-PCR were assessed for eligibility. A single oral dose of ivermectin (200  μg/kg) or placebo was administered under fasting. The primary outcome was time to a negative COVID-19 RT-PCR test result for SARS-CoV-2 nucleic acid, assessed using stratified log-rank test and Cox regression models.

Results

Overall, 112 and 109 patients were randomized to ivermectin and placebo, respectively; 106 patients from each group were included in the full analysis set (male [%], mean age: 68.9%, 47.9 years [ivermectin]; 62.3%, 47.5 years [placebo]). No significant difference was observed in the occurrence of negative RT-PCR tests between the groups (hazard ratio, 0.96; 95% confidence interval [CI] 0.70–1.32; p = 0.785). Median (95% CI) time to a negative RT-PCR test was 14.0 (13.0–16.0) and 14.0 (12.0–16.0) days for ivermectin and placebo, respectively; 82.1% and 84% of patients achieved negative RT-PCR tests, respectively.

Conclusion

In patients with COVID-19, single-dose ivermectin was ineffective in decreasing the time to a negative RT-PCR test.

Clinical Trial Registration

ClinicalTrials.gov, NCT04703205.