EUCTR2020-001825-29-ES进行中（未招募）1 期
CLINICAL TRIAL OF THE USE OF ANAKINRA (ANTI IL-1) IN CYTOKINE STORM SYNDROME (CSS) SECONDARY TO COVID-19 - ANA-COVID-GEAS
AVARRABIOMED - FUNDACIÓN MIGUEL SERVET0 个研究点目标入组 180 人开始时间: 2020年5月5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
- 180
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
- •? Age 18-80 years.
- •? Severe pneumonia COVID-19 defined as:
- •o Nasopharyngeal smear with RCP positive for SARS-CoV-2
- •o X-Rays (or other technique) pulmonary infiltrates compatible with pneumonia.
- •o 1 or more of the following criteria:
- •? Ambient air oxygen saturation <= 94% measured with a pulse oximeter.
- •? Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300.
- •? Sa:FiO2 (O2 saturation measured with pulse oximeter/ fraction of inspired O2) <=350.
- •?High suspicion of CSS that could resemble MAS-like: represented by IL-6 values > 40 pg/mL and/or ferritin >500 ug/L and/or PCR > 30 mg/L (rationale: = 5 upper normal limit) and/or LDH >300 UI/L. We have chosen these parameters because they are implemented in all the participating hospitals, they are a reflection of the cytokine storm and they have also been significant in terms of predicting mortality in patients with COVID-19 (9).
- •? Written informed consent. The protocol will be explained to the patient in front of a nurse who will act as a legal witness by signing the document on behalf of the patient.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •? Need for oro-tracheal intubation and/or invasive mechanical ventilation at the start of the study.
- •? AST/ALT with values greater than 5 times normal levels.
- •? Neutrophils < 1500 cell/mmc.
- •? Platelets < 50.000 cell/mmc.
- •? Sepsis or pneumonia documented by other pathogens than SARS-CoV-2.
- •? Existence of any life-threatening comorbidity or any other medical condition that, in the investigator's opinion, makes the patient unsuitable for inclusion.
- •? Inability to obtain informed consent.
- •? Positivity for HBV, HCV or tuberculin test serology.
- •? Pregnancy.
- •? Use of other previous or concomitant biological treatments. Patients in concomitant treatment with other biologicals that may interfere will be excluded: tocilizumab, canakinumab, TNFalfa inhibitors, JAKiinibs
- •? Severe renal dysfunction (estimated glomerular filtration rate = 30 ml / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
- •? Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
- •? Administration of plasma from convalescent patients who have recovered from SARS-CoV-2 infection.
- •? History of hypersensitivity or allergy to any component of the study drug.
- •? Enrollment in another concurrent intervention clinical trial, or intake of an investigational medication within three months or 5 half-lives prior to inclusion in this study, if deemed to interfere with the objectives of this study as assessed by the investigator.
- •? Predictable inability to cooperate with given instructions or study procedures.
研究者
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