Ulinastatin for COVID-19 in patients with breathlessness

Phase 3

Completed

• Conditions: Acute respiratory distress syndrome, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,

• Registration Number: CTRI/2020/06/025704
• Lead Sponsor: Bharat Serums and Vaccines ltd

Brief Summary

This is prospective,randomized, open label, comparative, clinical study to evaluate efficacy andsafety of Ulinastatin plus Standard-of-care compared to Standard-of-care (SOC) intreatment of acute respiratory distress syndrome (ARDS) in hospitalized COVID-19infection patient.



The patient will be randomized after informed consent to either group A or B.  Group A will receive ulinastatin for 7 days with SOC and group B will receive on SOC. The patient will be observed closely for any respiratory dysfunction or other organ dysfunction on drug administration days and day 14 and discharge. The patient will be discharged at investigator’s discretion.  The change from baseline values of respiratory functions,  inflammatory markers, APACHE Score will be noted. The patient will be telephoned on day 28 to note any morbidity or mortality.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2020-07-11
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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 (≤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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Number of days of use of Mechanical Ventilation	1.Number of days of use of Mechanical Ventilation | 2.Change from baseline in PF ratio (PaO2/FiO2)
2.Change from baseline in PF ratio (PaO2/FiO2)	1.Number of days of use of Mechanical Ventilation | 2.Change from baseline in PF ratio (PaO2/FiO2)

Secondary Outcome Measures

Name	Time	Method
Change in inflammatory markers	Change in Respiratory rate

Trial Locations

Locations (13)

All India Institute of Medical Sciences (AIIMS) Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

Atharva Multispecialty Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

B J Medical College and Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Belgavi Institute of Medical Sciences and Hospital; 🇮🇳 Belgaum, KARNATAKA, India

CARE Hospitals, Nampally; 🇮🇳 Hyderabad, TELANGANA, India

ESIC Medical College & Hospital; 🇮🇳 Faridabad, HARYANA, India

G.S.V.M. Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Indraprastha Apollo Hospitals; 🇮🇳 Delhi, DELHI, India

Mazumdar Shaw Medical Center Narayana Hrudayalaya; 🇮🇳 Bangalore, KARNATAKA, India

Medanta- The Medicity; 🇮🇳 Gurgaon, HARYANA, India

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All India Institute of Medical Sciences (AIIMS) Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Dibakar Sahu

Principal investigator

8059753143

dibakarsahu@aiimsraipur.edu.in