UMIN ID: UMIN000049727
Registered date:08/12/2022
Xocova tablets drug use-results survey
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | SARS-CoV-2 infection |
| Date of first enrollment | 2022/12/08 |
| Target sample size | 3000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Safety Incidence of adverse drug reactions |
|---|---|
| Secondary Outcome | Clinical outcome Time to resolution of COVID-19 symptoms in SARS-CoV-2 infected patients The number and rate of hospitalization for COVID-19 or death from any cause through day 28 |
Key inclusion & exclusion criteria
| Age minimum | 12years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | NA |
Related Information
| Primary Sponsor | Shionogi & Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Shionogi & Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Satoru Takashima |
| Address | 3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan 541-0042 |
| Telephone | +81-6-6209-6929 |
| satoru.takashima@shionogi.co.jp | |
| Affiliation | Shionogi & Co., Ltd. Pharmacovigilance Department |
| scientific contact | |
| Name | Masako Kaneto |
| Address | 3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan |
| Telephone | +81-6-6209-6974 |
| masako.kaneto@shionogi.co.jp | |
| Affiliation | Shionogi & Co., Ltd. Pharmacovigilance Department |