A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia

Genentech0 个研究点目标入组 452 人开始时间: 2021年1月21日最近更新: 2021年3月30日

试验速览

2020 non-peer-reviewed results in preprint https://doi.org/10.1101/2020.08.27.20183442 (added 21/01/2021) 2021 results in https://doi.org/10.1056/NEJMoa2028700 (added 17/03/2021)

•1. Hospitalized with COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan

•1. Known severe allergic reactions to TCZ or other monoclonal antibodies
•2. Active tuberculosis (TB) infection
•3. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
•4. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
•5. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
•6. Participating in other drug clinical trials (participation in COVID-19 antiviral trials may be permitted if approved by Medical Monitor)
•7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
•8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
•9. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
•10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
•11. Absolute neutrophil count (ANC) < 1000/ml at screening (per local lab)
•12. Platelet count < 50,000/mL at screening (per local lab)

发起方