An Investigator Initiated Prospective Multicentre, Double arm Interventional study of Ulinastatinalong with SOC in comparison to SOC alone (Pooled historical data) in hospitalised Subjects with moderate COVID-19.

Dr Manjunath B G0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•For Arm 1 & 2:
•Patients who meet all the following criteria are eligible to be enrolled
•in the study:
•-Males/females of Ã¢â?°Â¥ 18 years to Ã¢â?°Â¤ 65 years of age at the time of
•-Patients who can and willing to provide written Informed Consent (applicable only for Arm 1).
•-Hospitalized patients with confirmed diagnosis of moderate severity of COVID-19 infection with a real time or conventional RT-PCR positive test report (generated <72 hrs from baseline) from an ICMR approved laboratory for COVID testing.
•-Patients with SpO2 between 93 % - 90 % on room air.
•-Patients with Respiratory Rate Ã¢â?°Â¥24 breath /min.
•-Patients who are hospitalized within 24 hours at the time of enrolment.
•Additionally for Arm 2:
•-Patients discharged as per discharge criteria (defined in Protocol
•Section-5).
•-Patients with minimum one post discharge follow-up after 28 days of admission.
•-Patients for whom ordinal scale assessment is done during admission and discharge.

•Patients with any of the following are not to be enrolled in the study:
•-Patients who fall under mild or severity of COVID-19 (defined in Protocol section 5).
•-Patients with history of HIV/HCV/HBV positive or immunocompromised or tuberculosis.
•-Patients with significant co-morbidities at screening, as judged by the treating Investigator.
•-Patients with Moribund state in which death is perceived to be
•imminent (48 hours).
•-Patients with Chest CT severity score >15.
•-Patients with suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
•-Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma.
•-Patients who require mechanical ventilation or ECMO at Screening.
•-Patients with persisting hypotension despite volume resuscitation, requiring vasopressors to maintain MAP Ã¢â?°Â¥65 mmHg at screening.
•-Patients who have participated in any other clinical study within past three months.
•-Patients with known hypersensitivity to Ulinastatin.
•-Female patient who is breast-feeding, pregnant, or intends to
•become pregnant during the study.

发起方

Dr Manjunath B G