NCT04392531已完成4 期
Open, Controlled, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Cyclosporine Plus Standard Treatment vs Standard Treatment Only in Hospitalized Patients With COVID-19 Infection
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz7 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2020年4月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 7
- 主要终点
- Severity Category
研究概览
简要总结
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men over 18 years old
- •Clinical diagnosis of COVID19 infection (to be subsequently confirmed by PCR or specific IgM isotype Ac and with entry criteria according to the protocol of action (see Annex 2)
- •Acceptance and signing of the consent for the study after having received the appropriate information.
- •Exclusion criteria
- •Known allergy or hypersensitivity to any of the medications included in the treatment arms or to any of their components.
- •Contraindication for the use of any of the medications included (*)
- •CsA: IR EST 4.5 (FG <30 ml / min according to the Cockcroft-Gault formula)
- •Antimalarials (Chloroquine, hydroxychloroquine): Retinopathy, Myasthenia gravis.
- •Lopinavir / ritonavir: severe liver failure
- •Remdesivir, darunovir-ritonavir
- •Doxycycline, Azithromycin
- •Kidney failure (Stages 4 and 5: GFR <30 ml / min according to the cockcroft-Gault formula).
- •Decompensated liver disease (Child-Pugh stages B or C) or chronic infection with virus B
- •Pregnancy or lactation
- •Age over 75 years
- •Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Participation in observational studies is allowed.
- •Refusal to participate
- •Patient with a poor state of health or nutrition who, in the opinion of the researcher, has sufficient criteria of severity to interfere with the development of the study or its conclusions
- •At the investigator's discretion, the patient's inability to understand or comply with the study procedures
排除标准
- 未提供
研究组 & 干预措施
Group A (control)
Active Comparator
The control group will consist on the standard treatment that patients will receive according to hospital standard of care protocol.
干预措施: Standard treatment (Drug)
Group B (experimental)
Experimental
The experimental group will consist on cyclosporine added to the standard treatment that patients will receive according to hospital standard of care protocol.
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Severity Category
时间窗: 12 days
efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
次要结局
- Mortality Rate(through study completion, an average of 6 weeks)
- Number of Days in hospital(through study completion, an average of 6 weeks)
- Number of days in ICU beds(through study completion, an average of 6 weeks)
- Change in CPK(every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies))
- Fio2 Needs(through study completion, an average of 6 weeks)
- Adverse events rate(through study completion, an average of 6 weeks)
- Change in CRP(every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies))
- Change in ferritin(every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies))
- Change in LDH(every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment))
- Change in D Dimer(every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies))
- Change in IL-6(Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment))
- Change in KL-6(Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment))
- Change in Viral Load(Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment))
- Change specific antibodies(Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment))
研究者
研究点 (7)
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