Efficacy and safety of ANAkinra during Adult « COVID-19 » with Aggravating respiratory symptoms: a multicenter open-label controlled randomized trial - ANACONDA-COVID-19

CHRU de TOURS0 个研究点目标入组 240 人开始时间: 2020年4月15日最近更新: 2020年10月26日

试验速览

暂无简介。

•- Male or female= 18 years of age
•- Written informed consent of the patient or a proxy
•- Ability for participant to comply with the requirements of the study
•- Hospitalized patient with COVID-19 defined as
•Positive SARS-CoV2 RT-PCR
•Or typical COVID-19 Radiographic infiltrates on the CT scan (peripheral ground glass without lung cavitation, lymphadenopathy, or pulmonary nodules) other non COVID-19 diagnosis ruled out.
•- Patient with respiratory symptoms and requirement of oxygen therapy as defined:
•Oxygen therapy >= 4L/min to maintain Sp02>92% and respiratory rate >=24/min.
•Or patients under oxygen >= 1L/min and presenting worsening of oxygen requirement defined by an increase of oxygen therapy >= 2L/min to maintain Sp02>92%.
•- Inflammatory component C-Reactive Protein = 50mg/L.
•- Patients within the first 20 days from the onset of the first COVID-19 symptoms
•- Probabilistic antibiotics therapy according to local practice
•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 48
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 192

•- Respiratory failure related to other cause than COVID-19
•- Patients requiring mechanical ventilation at inclusion or requiring oxygen therapy equal or more than 11 liters per min to maintain Sp02>92%
•- Infectious diseases such as severe bacterial infections, aspergillosis, HIV, active HCV, active HBV, active tuberculosis
•- Contra indication to anti-IL1 receptor
•Known hypersensitivity to Anakinra
•Absolute neutrophil count (ANC)< 1500/mm3
•Liver cirrhosis score de Child-Pugh class C
•Live or attenuated vaccine in the past 8 weeks
•Pregnant or breast-feeding women
•- Patients with either legally protected status or who have been deprived of their freedom
•- Patient included in other interventional therapeutic research (e.g. = concurrent participation in French CoVID-19 is accepted)
•- Patients who have received previous treatment by anti-IL6R, anti-IL-6, anti-IL1R, anti-IL1 or anti-TNFa within 21 days preceding inclusion
•- Absence of Health Insurance
•- Existence of any life-threatening co-morbidity or any other medical condition which,in the opinion of the investigator, makes the patient unsuitable for inclusion.

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