A Phase 3, Prospective, Randomized, Open Label, Comparative, Clinical Study To Evaluate Efficacy And Safety Of Ulinastatin Plus Standard-Of-Care Compared To Standard-Of-Care In Treatment Of Acute Respiratory Distress Syndrome (ARDS) In Hospitalized COVID-19 Infection Patient

Bharat Serums and Vaccines ltd0 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

试验速览

暂无简介。

•1.Hospitalized adult aged >18-65 years inclusive
•2.Confirmed COVID-19 infection (RT â??PCR-test)
•3.Symptoms of mild or moderate ARDS
•(Ref: MoHFW/ ICMR Revised guidelines on clinical management of COVID-19- 31Mar2020)

•1.Patients with history of HIV/HCV/HBV positive or immunocompromised or TB
•2.Patients with significant co-morbidities at screening, as judged by the treating Investigator
•3.Moribund state in which death is perceived to be imminent (<=48 hours)
•4.Known hypersensitivity to any component of the investigational product
•5.Pregnant or nursing (lactating) women.
•6.Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
•7.Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
•8.Participation in any other clinical study

发起方

Bharat Serums and Vaccines ltd