Interleukin-1 (IL-1) and Interferon gamma (IFNg) inhibition during COVID 19 inflammation: Randomized, controlled study assessing efficacy and safety of Anakinra and Ruxolitinib - JAKINCOV

Centre Hospitalier Intercommunal de Toulon La Seyne-sur-mer0 个研究点目标入组 54 人开始时间: 2020年4月20日最近更新: 2020年6月2日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 54

研究概览入排标准研究者记录与标识符相似试验

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

•Women and men, age = 18 years.
•Confirmed respiratory tract SARS-coV-2 infection by at least one nasopharygeal sample or bronchoalveolar lavage PCR.
•Patient hospitalized with clinical, biological and radiological features corresponding to following stages :
•Stage 2B: corresponds to stage 2A, but with hypoxemia (Sa02 < 90 mmHg on room air,respiratory rate > 30/min) with biological inflammatory syndrome (CRP>150mg/l) .
•- Stage 3: ARDS defined as mechanically ventilated patient with PaO2/FiO2 < 300 mmHg for more than 24h., acute respiratory insufficiency and a systemic hyper inflammatory syndrome which is sometimes complicated by hemophagocytic lymphohistiocytosis and multi-organ failure syndrome.
•- Severe Stage 3 : ARDS as described above associated with any organ failure or syndrome such as :
•Shock with noradrenaline > 3mg/h
•Severe oligo-anuric renal insufficiency or necessitate renal dialysis
•Hepatocellular insufficiency or coagulopathy with factor V < 50%
•Myocarditis that caused severe heart failure and/or cardiogenic shock
•Hemophagocytic syndrome
•High ferritin > 5000 ng/mL
•Social Security affiliation or entitled to universal healthcare cover.
•Subject or legal representative having expressed written consent after 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 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 54

排除标准

•Pregnant or lactating women
•Patients transplanted with solid organs or hematopoietic stem cells
•HIV, HBV or HCV infection
•Non treated bacterial or mycotic infection
•Refusal to participate in the study
•Patient under administrative or judicial supervision
•Patient on exclusion period from another research
•Patient receiving psychiatric treatment according to article L3112-1 and L3113-1 which do not apply to article L1121-8
•Patient not able to read or understand french language which might prevent him from consenting to participate
•Any condition which could compromise safety of the patient or interfere in the conduct of the research according to the investigator.

研究者

发起方

Centre Hospitalier Intercommunal de Toulon La Seyne-sur-mer

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