drugset / Trial / NCT05007522
Ketotifen and Indomethacin Combination Treatment Clinical Trial for COVID-19
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and effectiveness of ketotifen and indomethacin taken together to improve symptoms related with COVID-19. Ketotifen and indomethacin are medications approved by the Food and Drug Administration (FDA) to treat diseases other than COVID-19. Their use in this study is investigational, meaning they have not been approved by the FDA to treat COVID-19.
Timeline
- Start
- 2022-05-03
- Primary completion
- 2024-06-20
- Completion
- 2024-06-20
Publications
- Background St John AL, Rathore APS. Early Insights into Immune Responses during COVID-19. J Immunol. 2020 Aug 1;205(3):555-564. doi: 10.4049/jimmunol.2000526. Epub 2020 Jun 8.
- Background Abraham SN, St John AL. Mast cell-orchestrated immunity to pathogens. Nat Rev Immunol. 2010 Jun;10(6):440-52. doi: 10.1038/nri2782.
- Background St John AL, Abraham SN. Innate immunity and its regulation by mast cells. J Immunol. 2013 May 1;190(9):4458-63. doi: 10.4049/jimmunol.1203420.
- Background Rathore AP, St John AL. Protective and pathogenic roles for mast cells during viral infections. Curr Opin Immunol. 2020 Oct;66:74-81. doi: 10.1016/j.coi.2020.05.003. Epub 2020 Jun 18.
- Background Kiani P, Scholey A, Dahl TA, McMann L, Iversen JM, Verster JC. In Vitro Assessment of the Antiviral Activity of Ketotifen, Indomethacin and Naproxen, Alone and in Combination, against SARS-CoV-2. Viruses. 2021 Mar 26;13(4):558. doi: 10.3390/v13040558.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indomethacin | Small molecule | 75 mg | — |
| Subject | Ketotifen | Small molecule | 2 mg | — |