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CTRI Number  CTRI/2020/06/025704 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 16/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ulinastatin for COVID-19 in patients with breathlessness  
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BSV_ULINA_20_03_IN ver 02/19-May-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhusudan Jaju 
Designation  Director-Critical Care Medicine 
Affiliation  CARE Hospitals 
Address  Room No 301, Department of Critical Care, Inpatient Building, CARE Hospitals-Nampally Exhibition Grounds, Road, Nampally

Hyderabad
TELANGANA
500001
India 
Phone  9440379476  
Fax    
Email  madhu_jaju123@rediffmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Mr Anirban Roy Chowdhury 
Designation  Vice President- Clinical Research and Pharmacovigilance 
Affiliation  Bharat serums and Vaccines LTd 
Address  3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai

Thane
MAHARASHTRA
400708
India 
Phone  022-45043456  
Fax  022-45043200   
Email  Anirban.roychowdhuryh@bharatserums.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Anirban Roychowdhury 
Designation  VP Clinical research and pharmacovigilance 
Affiliation  Bharat serums and Vaccines LTd 
Address  3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai

Thane
MAHARASHTRA
400708
India 
Phone  022-45043456  
Fax  022-45043200   
Email  anirban.roychowdhury@bharatserums.com  
 
Source of Monetary or Material Support  
Bharat Serums and Vaccines ltd. 3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai MAHARASHTRA 400708 India  
 
Primary Sponsor  
Name  Bharat Serums and Vaccines ltd 
Address  3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai MAHARASHTRA 400708 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dibakar Sahu  All India Institute of Medical Sciences (AIIMS) Raipur  PM 108, first floor, Department of Pulmonary, D-Block, Gate no. 04, GE Road, Tatibandh, Raipur, Chhattisgarh- 492099
Raipur
CHHATTISGARH 		 8059753143

dibakarsahu@aiimsraipur.edu.in 
Dr Sandeep Kumar Gupta  Atharva Multispecialty Hospital & Research Centre  Ground Floor, Atharva Multispecialty Hospital & Research Centre H-4lcomm-2. Constiirction Dive-2l. UP Avas Vikas Parishad Sector- E, Lucknow 226003
Lucknow
UTTAR PRADESH 		 9336077839

sandepkumar.gupta@rediffmail.com 
Dr Rohidas Borse   B J Medical College and Sassoon General Hospital   3rd Floor, Department of Medicine, Sassoon Road Station Road 411001
Pune
MAHARASHTRA 		 9923912525

rohidas_borse@gmail.com 
Dr Giridhar Patil  Belgavi Institute of Medical Sciences and Hospital  3rd Floor, Department of Medicine, Dr. B. R. Ambedkar Road, Belgavi, Karnataka- 590001
Belgaum
KARNATAKA 		 9845111575

drgiridharpatil@gmail.com 
Dr Madhusudhan Jaju  CARE Hospitals, Nampally  Room No 301, Department of Critical Care, Inpatient Building, CARE Hospitals-Nampally Exhibition Grounds, Road, Nampally
Hyderabad
TELANGANA 		 9440379476

madhu_jaju123@rediffmail.com 
Dr Salim Sheikh  ESIC Medical College & Hospital  Room No. 329, 3rd Floor, Academic Block, Department of Pharmacology, ESIC Medical College and Hospital, NH-3, NIT Behind BK Hospital
Faridabad
HARYANA 		 8470923822

drsalimsheikh@gmail.com 
Dr Apurva Agarwal  G.S.V.M. Medical College  Ground Floor, Department of Anaesthesia, Critical Care & Pain Management, G.S.V.M. Medical College Building, Swaroop Nagar,UP-208002
Kanpur Nagar
UTTAR PRADESH 		 9415368678

drapurva.agarwal@gmail.com 
Dr Sudha Kansal  Indraprastha Apollo Hospitals  Ground Floor, Department of Respiratory Medicine, Sarita Vihar, New Delhi- 110076
New Delhi
DELHI 		 9810399558

kansalsudha08@gmail.com 
Dr Harish Mallapura Maheshwarappa  Mazumdar Shaw Medical Center Narayana Hrudayalaya  Department of critical care medicine MICU 3rd floor, Mazumdar Shaw Medical Center Narayana Hrudayalaya, 258/A, Bommasandra Industrial Area, Hosur Road, Anekal Taluk, 560099
Bangalore
KARNATAKA 		 9869250397

dr.harishmm@rocketmail.com 
Dr Yatin Mehta  Medanta- The Medicity  Dept. of Critical Care & Anaesthesiology, Medanta- The Medicity,SECTOR-38, Gurgaon, Haryana- 122001, India
Gurgaon
HARYANA 		 911244141414

yatinmehta@hotmail.com 
Dr Sauren Panja  NH- Rabindranath Tagore International Institute of Cardiac Sciences  Critical Care Medicine, NH- Rabindranath Tagore International Institute of Cardiac Sciences, Premises no. 1489, 124, Mukundapur, E.M. Bypass, Kolkata 700099
Kolkata
WEST BENGAL 		 9831555433

drsauren@yahoo.co.in 
Dr Ajoy Krishna Sarkar  Peerless Hospitex Hospital and Research Center Ltd.  2nd Floor, Critical Care Department, Peerless Hospitex Hospital & Research Center Ltd., 360, Panchasayar, Kolkata- 700094 West Bengal.
Kolkata
WEST BENGAL 		 9830006644

ajoysarkar29@gmail.com 
Dr Nirav Bhalani  Rhythm Heart Institute  Ground Floor, Near Siddharth Bungalows, Sama-Salvi Road, Vadodara, Gujarat- 390022,India
Vadodara
GUJARAT 		 8128995863

drniravbhalani@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Clinical Research Ethics Committee, Peerless Hospitex Hospital and Research Center Ltd.  Approved 
Ethics Committee of All India Institute of Medical Sciences, Raipur  Approved 
Ethics Committee, G.S.V.M. Medical College  Approved 
Institutional Ethics Committee - Clinical Studies, Indraprastha Apollo Hospitals, New Delhi  Approved 
Institutional Ethics Committee B J Medical College and SGH  Approved 
Institutional Ethics Committee Belgavi Institute of Medical Sciences  Approved 
Institutional Ethics Committee CARE Hospitals  Approved 
Institutional Ethics Committee Human Research Translational Health Science and Technology Institute- ESIC hospital  Approved 
Institutional Ethics Committee, Atharva Multispecialty Hospital and Research Centre  Approved 
Medanta Institutional Ethics Committee  Approved 
NARAYANA HEALTH MEDICAL ETHICS COMMITTEE NH HEALTH CITY  Approved 
NHRTIICS Ethics Committee  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard of care  SOC -Hydroxychloroquine (400mg BD – for 1 day followed by 200mg BD for 4 days) + Azithromycin (500 mg OD for 5 days).  
Intervention  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 - Hydroxychloroquine (400mg BD – for 1 day followed by 200mg BD for 4 days) + Azithromycin (500 mg OD for 5 days).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Number of days of use of Mechanical Ventilation
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  
Outcome  TimePoints 
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
 		 baseline, day 1,2,3,4,5,6,7, 14 and discharge, day 28 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2020 
Date of Study Completion (India) 07/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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

 
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