ow dose of IL-2 In Acute respiratory DistrEss syndrome related to COVID-19 LILIADE-COVID - LILIADE-COVID

Assistance Publique Hôpitaux de Paris0 个研究点目标入组 30 人开始时间: 2020年4月7日最近更新: 2020年6月15日

适应症

试验速览

暂无简介。

•-Male or female, age = 18 years
•-Laboratory (RT-PCR) confirmed infection with SARS-CoV2
•-Patient is intubated and mechanically ventilated
•-Diagnosis of ARDS according to the Berlin definition of ARDS
•-Onset of ARDS <96 hours
•-Patient with French Social Security System
•-A written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator’s decision alone.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Previous history of ARDS in the last month
•2.Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
•3.Allogeneic bone marrow transplantation
•4.Active cancer
•5.Liver cirrhosis with basal Child and Pugh of C
•6.Pulmonary fibrosis
•7.Patient with end-of-life decision
•8.Patient not expected to survive for 24 hours
•9.Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
•10.Patient already enrolled in another interventional pharmacotherapy protocol
•on COVID-19
•11.Patient with known hypersensitivity to natural or recombinant Interleukin-2 or to any of the excipients
•12.Patient with burns to = 15% of their total body surface area
•13.Patient receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
•14. Patient under legal protection (protection of the court, or in curatorship or guardianship).

发起方