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CTRI Number  CTRI/2020/09/027941 [Registered on: 21/09/2020] Trial Registered Prospectively
Last Modified On: 04/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Single Arm Study 
Public Title of Study   Single arm study of Itolizumab in the treatment of COVID 19 complication. 
Scientific Title of Study   A multicentre, single arm, phase IV clinical trial to evaluate the safety and efficacy of Itolizumab for the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID 19.  
Trial Acronym  COVID 19 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ITOLI-C19-04-I-01, Version 4.0, Dated 30-11-2020   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rosemari De Souza 
Designation  Professor-General medicine 
Affiliation  Topiwala National Medical College & B. Y.L. Nair Charitable Hospita 
Address  Department of Medicine,
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Ground Floor, Dr. A. L. Nair Road, Mumbai - 400008, India
Mumbai
MAHARASHTRA
400008
India 
Phone  9820056230  
Fax    
Email  drrosemariedesouza@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subramanian Loganathan 
Designation  General Manager  
Affiliation  Biocon Biologic India Limited 
Address  Biocon Biologic India Limited, Biocon House, Semicon Park
Electronics City Phase 2
Bangalore
KARNATAKA
560100
India 
Phone  08028085305  
Fax    
Email  subramanian.l101@biocon.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Sivakumar Vaidyanathan 
Designation  General Manager 
Affiliation  Biocon Biologic India Limited 
Address  Biocon Biologic India Limited, Biocon House, Semicon Park
Electronics City Phase 2
Bangalore
KARNATAKA
560100
India 
Phone    
Fax    
Email  sivakumar.vaidyanathan@biocon.com  
 
Source of Monetary or Material Support  
Biocon Biologics India Limited, Biocon House, Semicon Park, Bengaluru- 560100, Karnataka, India 
 
Primary Sponsor  
Name  Biocon Biologics India Limited 
Address  Biocon House, Ground Floor, Tower-3, Semicon Park, Electronic City, Phase - II, Hosur Road, Bengaluru, Karnataka – 560100 
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 = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manoj Kumar Panigrahi  All India Institute Of Medical Sciences  All India Institute Of Medical Sciences, Room No - 425, 4th Floor, Academic Block, AIIMS, Bhubaneswar, Sijua, Patrapada, Bhubaneswar -751019. India
Khordha
ORISSA 		 9438884282

pulmed_manoj@aiimsbhubaneswar.edu.in 
Dr Atul Jindal  All India Institute of Medical Sciences (AIIMS),   Department of Pediatrics, All India Institute of Medical Sciences (AIIMS), Tatibandh, Great Estern, Road, Raipur 492099, Chhattisgarh, India
Raipur
CHHATTISGARH 		 8224014667

dratuljindal@gmail.com 
DrNilesh Mahale  Deenanath Mangeshkar Hospital  Deenanath Mangeshkar Hospital,Near Deenanath Mangeshkar Hospital Road, Mhatre Bridge, Erandwane, Pune, Maharashtra 411004
Pune
MAHARASHTRA 		 9082919254

nileshmahale0@gmail.com 
Dr Nikhil Verma  ESIC Medical College and Hospital  Department of Medicine, ESIC Medical College and Hospital, NH-3, NIT Behind BK Hospital, Haryana 121001, India
Faridabad
HARYANA 		 8447748603

drnick.ver@gmail.com 
DrChirag Rathod  GMERS Medical College & Hospital,  Department of Medicine, GMERS Medical College & Hospital, Room No.601, 6th Floor, Old TB Hospital Campus, Gotri Main road, Gotri, Vadodara – 390021 Gujarat, India
Vadodara
GUJARAT 		 9173765727

chirag_rthd@rediffmail.com 
DrSushant Hiraman Meshram  Government medical college and hospital  Department of Respiratory Medicine, Super-speciality Hospital, Govt. Medical College, Room 43, 4th floor- Super Speciality Hospital, Govt. Medical College and Hospital, Nagpur-440003, Maharashtra, India.
Nagpur
MAHARASHTRA 		 9860990379

drsushant.in@gmail.com 
Dr Ajay Jhaveri  Kasturba Hospital of Infectious Disease  Department of Medicine, Kasturba Hospital of Infectious Disease, Sane Guruji Marg,Mumbai - 400 011
Mumbai
MAHARASHTRA 		 9867433330

drajayjhaveri@gmail.com 
Dr Madhu Kumar  KR Hospital  Department of General Medicine, 1st floor KR Hospital Attached to Mysore Medical College and Research Institute Irwin Road,Mysore - 570001 Karnataka
Mysore
KARNATAKA 		 9743105248

drkumarmadhu9@gmail.com 
Dr Anand Nikalje  MGM Medical College & Hospital  Department of Pharmacology, MGM Medical College & Hospital, Clinical Research Unit, Covid Ward,Basement, Bulding B, N-6, CIDCO, Aurangabad – 431003, Maharashtra, India.
Bangalore
KARNATAKA 		 9822496190

anandnikalje@rediffmail.com 
Dr Arjun Alva  Narayana Hrudayalaya Limited  Department of Intensive Care unit, Mazumdar Shaw Medical Center, Narayana Hrudalaya Ltd, No 258/A, Bommansandra Industrial Area, Hosur Road, Anekal Taluk, Bangalore -560099
Bangalore
KARNATAKA 		 9108026001

arjunalva@gmail.com 
Dr Jayanta Kumar Panda  S.C.B. Medical College & Hospital  PG Department of Medicine, S.C.B. Medical College and Hospital, Cuttack-753001, Odisha, India.
Cuttack
ORISSA 		 9437028282

drjayantpanda@gmail.com 
Dr Liyakat Ali Gauri   S.P.Medical College & AG of Hospitals,   Department of Medicine S.P.Medical College & AG of Hospitals, Bikaner 334003, Rajasthan
Bikaner
RAJASTHAN 		 9829795116

drliyakatgauri@rediffmail.com 
Dr Sudhir Bhandari  Sawai Mansingh Medical College (SMS) Medical College  Department of Medicine and Endocrine services, Sawai Mansingh Medical College (SMS) Medical College. D-126, A, Krishna Marg, University Road, Bapu Nagar, SMS, Medical College & Attached Hospitals, Jaipur – 302004, India
Jaipur
RAJASTHAN 		 9829078844

drs_bhandari@yahoo.com 
Dr Mahendran  SRM Institutes for Medical Science  Department of Critical care, SRM Institutes for Medical Science, , 21, Dr Thirumoorthy Nagar Main Rd, Tirumurthy Nagar, Nungambakkam, Chennai, Tamil Nadu 600034
Chennai
TAMIL NADU 		 9840176626

mahendran61@gmail.com 
Dr Rahul Ashok Darnule  St. Georges Hospital, Grant Government Medical College & Sir JJ Group of Hospitals  Research Department, First Floor, Near Superintendents Office, St. Georges Hospital, Grant Government Medical College & Sir JJ Group of Hospitals, P DMello Road, CST, Mumbai- 400001, Maharashtra, India
Mumbai
MAHARASHTRA 		 9372517363

rahuldarnule@gmail.com 
DrRosemarie De Souza  Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,  Department of Medicine, Topiwala National Medical College & B. Y. L. Nair Charitable Hospital, Ground Floor, Dr. A. L. Nair Road, Mumbai - 400008, India
Mumbai
MAHARASHTRA 		 9820056230

drrosemariedesouza@gmail.com 
Dr Raveendra  Victoria Hospital Bangalore Medical College and Research Institute   Department of Medicine, Victoria Hospital Bangalore Medical College and Research Institute K R Road, Fort, Bengaluru, Karnataka – 560002, India
Bangalore
KARNATAKA 		 9448134587

drkrraveendra@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
All India Institute Of Medical Sciences, AIIMS, Bhubaneswar  Approved 
Ethics Committee Jaslok Hospital and Research Centre Jaslok Hospital and Research Centre Jaslok Hospital  Approved 
Ethics Committee of BMCRI, Bangalore Medical College and Research Institute, Fort K R Road Bengaluru, (Bangalore) Urban, Karnataka   Approved 
Ethics Committee S.P Medical College & A.G. Hospitals, HRMC Cardiovascular science & Research Centre, Bikaner   Approved 
Ethics Committee, S.M.S. Medical College and Attached Hospitals, J.L.N. Marg, Jaipur, Rajasthan – 302004, India  Approved 
IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysuru, Mysuru (Mysore), Karnataka – 570001, India  Approved 
IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute, Mysore Medical College and Research Institute, Irwin Road, Mysuru (Mysore), Karnataka – 570001, India  Approved 
Institution Ethics Committee, All India Institute Of Medical Sciences (AIIMS), Department of pharmacology, 2nd floor, south wing, Medical college complex, Gate no. 5, Tatibandh  Approved 
Institutional Ethics Committee T.N.M.C and Nair Hospital Mumbai Central, Mumbai  Approved 
Institutional Ethics Committee For Sehgal Nursing Home, Sehgal Nursing Home, A6, Panchwati, Opp. Azadpur, New Sabzi Mandi, Delhi – 110033, India  Approved 
Institutional Ethics Committee, 14th Floor, Super Specialty Building, LMMFS Deenanath Mangeshkar Hospital and Research Centre, Off Karve Road, Erandawane, Pune, Maharastra-411004, India  Approved 
Institutional Ethics Committee, GMC, Nagpur Government Medical College and Hospital, Nagpur  Approved 
Institutional Ethics Committee, SCB Medical College & Hospital, Cuttack – 753007, Odisha, India  Approved 
Institutional Ethics Committee, SRM Institues for Medical Science (SIMS Hospital), No:11, Jawaharlal Nehru Salai, Vdapalani, Chennai  Approved 
Institutional Human Ethics Committee, GMERS Medical College & General Hospital, Gotri, Vadodara  Approved 
MGM Ethics Committee for Research on Human Subject (MGM-ECRHS) Pharmacology Department  Approved 
Narayana Hrudayalaya Medical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intervention  1.6 mg/kg given as IV infusion as a starting dose. Additional dose of 0.8mg/Kg can be administered after 7 days based on the physician’s discretion.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female adults above >18 years
2. Informed consent for participation in the study
3. Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR)
4. Hospitalized with ARDS due to clinical worsening of COVID-19 infection
5. Oxygen saturation at rest in ambient air ≤94%
6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of ≤ 200
7. Baseline serum ferritin level ≥ 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available


 
 
ExclusionCriteria 
Details  1. Known severe allergic reactions to monoclonal antibodies
2. Active tuberculosis (TB) infection
3. History of inadequately treated tuberculosis or latent tuberculosis
4. In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments
5. Patient on invasive mechanical ventilator support
6. Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months
7. Patient on treatment of anti-IL-6 as a part of supportive care
8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
9 Patients with known history of Hepatitis B, Hepatitis C or HIV  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)  		 Up to 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
One-month mortality rate   Up to 1 month 
Biomarkers (IL-6 and TNF-a)   up to 1 month 
Change in inflammatory markers like CRP (C-reactive protein) level, Serum Ferritin, D- dimer and LDH  Up to 1 month 
Proportion of patients without deterioration of lung function as measured by stable/ improved SpO2 without increasing FiO2   Up to 1 month 
PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen) ratio  Up to 1 month 
Duration of hospitalization   Up to 1 month 
Remission of respiratory symptoms (time to independence from non-invasive mechanical ventilation calculated in days)   Up to 1 month  
Clinical Status as improvement of 1 and 2 point on an ordinal scale   up to 1 month  
Incidence, nature and severity of adverse events causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)   Up to 1 month 
Remission of respiratory symptoms(time to independence from oxygen therapy in days)  Up to 1 month 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   26/09/2020 
Date of Study Completion (India) 10/07/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Multi-Centre, single arm, phase IV clinical trial

The study described in this protocol is designed to evaluate safety and efficacy of Itolizumab in the post marketing setting. This study will be conducted as to provide additional safety data after use of Itolizumab intravenous infusion in the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome patients due to COVID 19 administered in clinical practice as per the prescribing information. 
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