EUCTR2020-001319-26-ES进行中（未招募）1 期
Multicenter, randomized, controlled, open-label clinical trial to assess the prognostic implications of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive. - FJD-COVID-ESTATINAS
Instituto de Investigación Sanitaria Fundación Jiménez Díaz0 个研究点目标入组 1,080 人开始时间: 2020年5月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,080
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients older than 45 years.
- •2. Diagnosed with a positive COVID 19 and having required hospital admission and discharges in the last 3 months, even if they tried to recruit as soon as possible from the time of discharge or just for a follow-up visit when they finished with the medications to the COVID or washout period after cyclosporine.
- •3. Acceptance and signing of the consent for the study after having received the appropriate information.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1080
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1080
排除标准
- •1. Chronic statin treatment at the time of hospitalization.
- •2. Known allergy or hypersensitivity to statins or any of their components,
- •3. History of statin intolerance due to increased transaminases, CPK or intolerable myalgias.
- •4. Severe renal failure: Estimated glomerular filtration <30mL / min / 1.73 m2 calculated by the CKD-EPI formula.
- •5. Survival <1 year for any known comorbidity
- •6. Previous liver or heart transplant
- •7. Patients with myopathy
- •8. Patients with concomitant treatment with cyclosporine
- •9. Liver dysfunction (ALT / AST or BT above 3 times the upper limit of normal)
- •10. Potentially fertile women who are unwilling to use an effective method of contraception.
- •11. Pregnancy or lactation
- •12. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Simultaneous participation in observational studies is allowed.
- •13. At the investigator's discretion, the patient's inability to understand or comply with the study procedures
- •14. Refusal to participate
研究者
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