Clinical study of Ulinastatin along with standard of care in comparison to standard of care alone (Pooled historical data) in hospitalised moderate COVID-19 patients
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/08/035593
- Lead Sponsor
- Dr Manjunath B G
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
For Arm 1 & 2:
Patients who meet all the following criteria are eligible to be enrolled
in the study:
-Males/females of � 18 years to � 65 years of age at the time of
consent.
-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 �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 �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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Incidences of all-cause mortality [Time Frame: From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days, in both Arms] <br/ ><br> <br/ ><br>2.Evaluation of Clinical progression based on 8-point ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID- 2019) R and D) [Time frame: baseline to EoT, in both Arms]. <br/ ><br>Timepoint: 1. From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks, in both Arms] <br/ ><br> <br/ ><br>2. Baseline to 4 weeks, in both Arms <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Duration of Hospital Stay [Time Frame- Up to day 28, in both Arms] <br/ ><br>2.Number of subjects requiring ICU stay [Time Frame- Up to day 28, in both Arms] <br/ ><br>3.Change in oxygen saturation [Time Frame- baseline to EoT, in both Arms] <br/ ><br>4.Number of subjects required non-invasive ventilation [Time Frame-Up to day 28, in both Arms] <br/ ><br>5.Number of subjects required mechanical ventilation [Time Frame-Up to day 28, in both Arms] <br/ ><br>6.Lab parameter-Change in CD4/CD8, IL6, D-dimer, CRP [Time frame: baseline to EoT] <br/ ><br>Timepoint: 1.Baseline to Day 7 <br/ ><br>2.Baseline to Day 7 <br/ ><br>3.Baseline to EoT <br/ ><br>4.Baseline to Day 7 <br/ ><br>5.Baseline to Day 7 <br/ ><br>6.Baseline to EoT