Ivermectin for Severe COVID-19 Management
Summary
In this multicenter study; it was aimed to investigate the effectiveness and safety of ivermectin use in the treatment of patients with severe COVID-19 pneumonia that have no mutations which alter ivermectin metabolism and cause side effects.
Timeline
- Start
- 2020-05-11
- Primary completion
- 2020-09-02
- Completion
- 2020-09-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Control Group vs Study Group; p = 0.43; Chi-squared NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.14; Wilcoxon (Mann-Whitney) NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.68; Wilcoxon (Mann-Whitney) NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.15; Wilcoxon (Mann-Whitney) NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.37; Wilcoxon (Mann-Whitney) NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.12; Wilcoxon (Mann-Whitney) NCT04646109 ↗
registry analysis (superiority test); Control Group vs Study Group; p = 0.22; Wilcoxon (Mann-Whitney) NCT04646109 ↗
Publications
- Background Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background Jean SS, Lee PI, Hsueh PR. Treatment options for COVID-19: The reality and challenges. J Microbiol Immunol Infect. 2020 Jun;53(3):436-443. doi: 10.1016/j.jmii.2020.03.034. Epub 2020 Apr 4.
- Background Croci R, Bottaro E, Chan KW, Watanabe S, Pezzullo M, Mastrangelo E, Nastruzzi C. Liposomal Systems as Nanocarriers for the Antiviral Agent Ivermectin. Int J Biomater. 2016;2016:8043983. doi: 10.1155/2016/8043983. Epub 2016 May 8.
- Background Heidary F, Gharebaghi R. Ivermectin: a systematic review from antiviral effects to COVID-19 complementary regimen. J Antibiot (Tokyo). 2020 Sep;73(9):593-602. doi: 10.1038/s41429-020-0336-z. Epub 2020 Jun 12.
- Background Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivermectin | Small molecule | 200 ug/kg | Other |