Ulinastatin for COVID-19 in patients with breathlessness

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025704

Enrollment

120

Registered

2020-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

Intervention1: ulinastatin with Standard of care : Ulinastatin -IV infusion in a dose of 200,000 units (diluted in 100 ml of 0.9% saline) 3 times a day (Every 8 hours) for 7 days SOC - Hydroxychloroq

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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 ( 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

Design outcomes

Primary

Measure	Time frame
1. Number of days of use of Mechanical Ventilation 2. Change from baseline in PF ratio (PaO2/FiO2) Timepoint: 1. Number of days of use of Mechanical Ventilation 2. Change from baseline in PF ratio (PaO2/FiO2)	—

Secondary

Measure	Time frame
Change in inflammatory markers Change in Respiratory rate Change in SpO2 Days of ICU stay Days of hospital stay progressed to organ dysfunction Change in APACHE 2 score progressed to sepsis or septic shock Mortality within day 28 Timepoint: baseline, day 1,2,3,4,5,6,7, 14 and discharge, day 28	—

Countries

India

Contacts

Public ContactAnirban Roychowdhury

Bharat serums and Vaccines LTd

Anirban.roychowdhuryh@bharatserums.com022-45043456

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026