UMIN ID: UMIN000054128
Registered date:12/04/2024
Ensitrelvir Fumaric Acid in Health care workers with SARS-CoV-2 Retrospective Chart Review - Tokyo Rinkai Hospital -
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | COVID-19 |
| Date of first enrollment | 2024/04/12 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Average number of days from onset of symptoms to return to work. |
|---|---|
| Secondary Outcome | Virus residual rate proportion (antigen quantitative test >100 pg / ml) on the planned date of return to work for the re-examination. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Healthcare workers at Tokyo Rinkai Hospital who meet any of the following criteria will be excluded from the study. 1)Healthcare workers who were not treated according to the package insert 2)Healthcare workers who received anti-SARS-CoV-2 drugs other than ensitrevir 3)Healthcare workers who refused to participate in this study |
Related Information
| Primary Sponsor | SHIONOGI & Co., Ltd. |
|---|---|
| Secondary Sponsor | Japan |
| Source(s) of Monetary Support | SHIONOGI & Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuko Ariwa |
| Address | 1-8, Dosho-machi 3-chome, Chuo-ku, Osaka 541-0045, Japan Japan 541-0045 |
| Telephone | 06-6202-2161 |
| yasuko.ariwa@shionogi.co.jp | |
| Affiliation | SHIONOGI & Co., Ltd. Medical Affair |
| scientific contact | |
| Name | Makoto Katsuta |
| Address | 1-4-2 Rinkaicho, Edogawa-ku, Tokyo-to Japan |
| Telephone | 03-5605-8811 |
| katsuta-m@tokyorinkai.jp | |
| Affiliation | Tokyo Rinkai Hospital Pharmacy |