Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Ulinastatin along with standard of care: The subjects will be administered with study product three times a day (Every 8 hours) for 5 to 7 days (as per PIs discretion). Each dose consi
Sponsors
Dr Manjunath B G
Eligibility
Inclusion criteria
Inclusion criteria: 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 -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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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] 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]. 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] 2. Baseline to 4 weeks, in both Arms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Duration of Hospital Stay [Time Frame- Up to day 28, in both Arms] 2.Number of subjects requiring ICU stay [Time Frame- Up to day 28, in both Arms] 3.Change in oxygen saturation [Time Frame- baseline to EoT, in both Arms] 4.Number of subjects required non-invasive ventilation [Time Frame-Up to day 28, in both Arms] 5.Number of subjects required mechanical ventilation [Time Frame-Up to day 28, in both Arms] 6.Lab parameter-Change in CD4/CD8, IL6, D-dimer, CRP [Time frame: baseline to EoT] Timepoint: 1.Baseline to Day 7 2.Baseline to Day 7 3.Baseline to EoT 4.Baseline to Day 7 5.Baseline to Day 7 6.Baseline to EoT | — |
Countries
India
Contacts
Public ContactDr Manjunath B G
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Outcome results
None listed