A Phase-III, Multicenter, Prospective, Double Blind, Randomized, Parallel, Clinical Study Evaluating the Efficacy, Safety and Tolerability of Hetero-Tocilizumab in Cytokine Storm of Severe Coronavirus Disease (Covid-19) Pneumonia (TOCICOVID Study)

Hetero Biopharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent.
•2. Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
•3. Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air.
•4. Patients with elevated IL-6 ( >40 pg/ml), D-dimer >1.5 Î¼gFEU /ml, Elevated CRP ( >75mg/L) and ferritin 5X

•1. Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation.
•2. Patients requiring intubation and mechanical ventilation
•3. Patients with ALT/AST >= 5 x upper limit of normal (ULN)
•4. Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm
•5. Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months
•6. Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer
•7. Evidence of multiorgan failure
•8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
•9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely

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