COVID 19: Experimental use of tocilizumab (Roactemra®) in severe SARS-CoV-2 related pneumonia.

CHU AMBROISE PARE0 个研究点目标入组 60 人开始时间: 2020年4月15日最近更新: 2020年8月10日

试验速览

暂无简介。

•- Positive COVID status as defined by:
•PCR documented SARS-CoV-2 carriage in nasopharyngeal sample or evocative thoracic scan
•images of COVID-19 associated with typical clinical presentation
•- Hospitalized patients aged = 18 and = 75 years old
•- Signs of severe COVID-19 pneumonia (3 of the followings)
•- Patient wheezing or unable to speak in full sentences while at rest/with minimal
•- Respiratory rate >22
•- PaO2 <65 mmHg or SpO2 <90%
•- Repeated chest imaging is significantly worsening
•despite being on standard of care, which may include anti-viral treatment, low dose steroids
•and antibiotics.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- Immunosuppresion
•- End stage renal failure and dialysis
•- Life expectancy < 1 year (due to a condition other than COVID)
•- Active neoplasia (treated or not)
•- Breastfeeding and pregnant patients
•- Known severe allergic reactions to TCZ or other monoclonal antibodies
•- Non treated HIV infection, chronic B hepatitis, active C hepatitis, active tuberculosis
•- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past
•- Participating in other drug clinical trials

发起方

CHU AMBROISE PARE