EUCTR2020-001405-23-ES进行中（未招募）1 期
Randomized phase II clinical trial of ruxolitinib plus simvastatin in the prevention and treatment of respiratory failure of COVID-19.Ruxo-Sim-20 clinical trial. - Ruxo-Sim-20
Fundación de Investigación HM Hospitales0 个研究点目标入组 94 人开始时间: 2020年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
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
- •- Patients who have given their written informed consent. If it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the SARS-Cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history.
- •- Clinical diagnosis or confirmed by analytical tests (PCR of viral RNA or detection of antiSARS-Cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the WHO 7-point ordinal scale of severity categorization for COVID.
- •- Platelets> 50,000 / uL, neutrophils> 500 / ul
- •- Kidney or liver failure is not a contraindication, dose adjustment will be made according to the SmPC
- •- Women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception:
- •* Negative serum or urine pregnancy test in the 72 hours prior to the start of treatment.
- •*Use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •- Documented concomitant severe bacterial or fungal infection
- •- Infection with HIV, HCV, HBV
- •- Age <18 years
- •- Thrombocytopenia <50,000 / uL, Neutropenia <500 / uL
- •- Women of childbearing age who do not use an effective contraceptive method.
- •- Pregnant or lactating women.
- •- Patients who do not want or cannot comply with the protocol.
- •- Patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small intestine or inability to swallow oral medication. Previous partial or total gastrectomy is not an exclusion criterion
研究者
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