A study to assess the safety and efficacy of Clazakizumab in patients with COVID-19 and kidney disease. - CLiCK Study

Imperial College London0 个研究点目标入组 20 人开始时间: 2020年6月29日最近更新: 2020年8月3日

试验速览

暂无简介。

•1. Hospitalised with COVID-19 infection with pulmonary involvement (i.e. consistent chest imaging abnormalities).
•2. COVID-19 infection defined by as per WHO criteria (including a positive PCR of any specimen e.g., respiratory, blood, urine, stool, other bodily fluid) or detectable IgM antibody
•3. Clinical deterioration following admission to hospital defined as increasing oxygen requirement and clinical signs of hyper-inflammation (raised ferritin, d-dimer, CRP)
•4. >18 years of age
•5. Able to give consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•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 10

•1. Unable to provide informed consent
•2. Known severe allergic reactions to Clazakizumab
•3. Active tuberculosis (TB) infection
•4. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19), which in the investigator’s opinion, precludes the patient's safe participation in and completion of the study.
•5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening or at baseline
•6. Absolute neutrophil count (ANC) < 1000/mL at screening and baseline
•7. Platelet count < 50,000/mL at screening and baseline
•8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
•9. Patients with inflammatory bowel disease (except fully excised ulcerative colitis), diverticular disease (unless fully excised), or history of GI perforation
•10. Able to participate in other COVID19 drug clinical trials (participation in COVID19 antiviral trials may be permitted)

发起方