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CTRI Number  CTRI/2021/05/033703 [Registered on: 20/05/2021] Trial Registered Prospectively
Last Modified On: 22/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Test the Effectiveness and Side Effects of Hetero-Tocilizumab in Severe COVID-19 Patients 
Scientific Title of Study   A Phase-III, Multicenter, Prospective, Double Blind, Randomized, Parallel, Clinical Study Evaluating the Efficacy, Safety and Tolerability of Hetero-Tocilizumab in Cytokine Storm of Severe Coronavirus Disease (Covid-19) Pneumonia (TOCICOVID Study) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/TOCICOVID/06/2020; Version 3.0 Dated 12/May/2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Sreenivasa Chary S 
Designation  General Manager 
Affiliation  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha 
Designation  Sr. Vice President 
Affiliation  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. & Fax No.: 914023810110 
 
Primary Sponsor  
Name  Hetero Biopharma Limited 
Address  Hetero Biopharma Limited, H. No. 8-3-166/1,2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Erragadda, Hyderabad, Telangana, India, 500018. Tel No. & Fax No.: 914023810110 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swapnav Borthakur  Down Town Hospital  Department of General Medicine, GS Rd, Bormotoria, Guwahati-781006, Assam
Dhubri
ASSAM 		 9864038704

swapnav.borthakur@gmail.com 
Dr D Anil Kumar  Gandhi Hospital and Medical College  Department of Medicine, Inpatient block, 2nd floor, Musheerabad, Secunderabad-500003, Telangana
Hyderabad
TELANGANA 		 9440523902

anilddrmd@gmail.com 
Dr Chirag Chandrakant Rathod  GMERS Medical College & Hospital  Department of General Medicine, Old TB Hospital Campus, Gotri Road, Gotri, Vadodara -390002, Gujarat
Vadodara
GUJARAT 		 9909035630

Chirag.rthd@rediffmail.com 
Dr SSVV Narsinga Rao  Govt. Medical college & Govt. General Hospital (Old RIMSGGH)  Department of General Medicine, Srikakulam-532001, Andhra Pradesh
Srikakulam
ANDHRA PRADESH 		 8942279033

drnarasingaraossvv@yahoo.com 
Dr Sanjiv Maheshwari  Jawahar Lal Nehru Medical College  Department of Medicine, Kala Bagh, Ajmer-305001, Rajasthan
Ajmer
RAJASTHAN 		 9460479888

doctor.sanjiv@gmail.com 
Dr Karnik Niteen Dattatreya  Lokmanya Tilak Municipal Medical College & General Hospital  Department of General Medicine, Dr. Ambedkar Road, Sion, Mumbai - 400022, Maharashtra, India
Mumbai
MAHARASHTRA 		 9821483404

drndkarnik@hotmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Department of Pulmonary Medicine, Central Spine, Agrasen Aspatal Marg,Sector-7,Vidhyadhar Nagar,Jaipur-302039, Rajasthan
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Keyur Madan Brahme  Sir Sayaji Rao General Hospital  Department of General Medicine, Medical College of Baroda, Jail Road (Indira Avenue), Vadodara - 390001, Gujarat
Vadodara
GUJARAT 		 9727729105

keyurbrahme@gmail.com 
Dr AV Rao  St,Theresa’s Hospital  Department of General Medicine, Sanath Nagar, Hyderabad-500018, Telangana
Hyderabad
TELANGANA 		 9440040662

drvenkateshwararaoavula@gmail.com 
Dr N Kumarasamy  VHS Infectious Diseases Medical Centre  Department of Infectious Diseases, CART Clinical Research Site, Voluntary Health Services, Taramani, Chennai, 600113, Tamil Nadu
Chennai
TAMIL NADU 		 9176912007

kumarasamyn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics committee, Down Town Hospital Building G.S Road Dispur Guwahat Assam India EC Reg. No. ECR/549/Inst/AS/2014/RR-20  Submittted/Under Review 
Ethics Committee, St. Theresa’s Hospital, Sanath Nagar, Hyderabad- 500018 EC Reg. No. ECR/230/Inst/AP/2013/RR-19  Submittted/Under Review 
Institutional Ethics Committee for Human Research, Lokmanya Tilak Municipal Medical College, Staff and Research Society, L.T.M Medical College Building, 2nd Floor, Room No. 17, Sion, Mumbai - 400022 EC Reg. No. ECR/266/Lokmanya/Inst/MH/2013/RR- 19  Submittted/Under Review 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital Balaga Srikakulam Srikakulam Srikakulam Andhra Pradesh EC Reg. No. ECR/492/Inst/AP/2013/RR-20  Submittted/Under Review 
Institutional Ethics committee, Ganadhipati Purushottam Shekhawati Hospital and Research Centre A/2, Fourth Floor Opp Times Square, Central Spine Vidhyadhar Nagar Jaipur Rajasthan EC Reg. No. ECR/1222/Inst/RJ/2019  Approved 
Institutional Ethics Committee, Gandhi Medical College Gandhi Hospital Musheerabad Secunderabad Telangana India EC Reg. No. ECR/180/Inst/AP/2013/RR-16  Submittted/Under Review 
Institutional Ethics committee, Jawahar Lal Nehru Medical College, Kala Bagh, Ajmer, Rajasthan-305001 EC Reg. No. ECR/1156/Inst/RJ/2018  Submittted/Under Review 
Institutional Ethics Committee, Sir SayajiRao General Hospital, Medical College, Baroda, Jail Road (Indira Avenue), Vadodara – 390001 EC Reg. No. ECR/65/Inst/GJ/2013/RR-19  Submittted/Under Review 
Institutional Human Ethics Committee GMERS Medical College and Hospital, Gotri Old TB Hospital Campus Gotri Main Road, Gotri Vadodara Vadodara Gujarat - 390021 India EC Reg. No. ECR/28/Inst/GJ/2013/RR-19  Submittted/Under Review 
The Voluntary Health Services Institutional Ethics Committee, Voluntary Health Services, Taramani, Chennai-600113 EC Reg. No. ECR/752/Inst/TN/2015/RR-19  Submittted/Under Review 
 
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  Hetero-Tocilizumab  Hetero-Tocilizumab 8mg/kg (maximum 800mg) once on Day 1. This is a single dose administration intravenously over 60 min infusion 
Comparator Agent  RMP-Tocilizumab  RMP-Tocilizumab 8mg/kg (maximum 800mg) once on Day 1. This is a single dose administration intravenously over 60 min infusion 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent.
2. Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen
3. Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air.
4. Patients with elevated IL-6 (>40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP (>75mg/L) and ferritin 5X ULN 
 
ExclusionCriteria 
Details  1. Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation.
2. Patients requiring intubation and mechanical ventilation
3. Patients with ALT/AST ≥ 5 x upper limit of normal (ULN)
4. Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm
5. Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months
6. Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer
7. Evidence of multiorgan failure
8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cumulative proportion of patients requiring mechanical ventilation  Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Mortality Rate during the study  Day 14 and 28 
Proportion of patients with 2-point decrease in ordinal scale (as recommended by WHO)  Day 14 and 28 
Time to 2-point decrease in ordinal scale (as recommended by WHO) from randomization.  Up to Day 28 
Incidence and severity of TEAEs (clinical and laboratory) during the study  All Visits 
Proportion of patients discontinued the study due to adverse events  All Visits 
 
Target Sample Size   Total Sample Size="188"
Sample Size from India="188" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   23/05/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a multicentric, prospective, double blind, randomized, parallel, clinical study to evaluate the efficacy, safety and tolerability of Hetero-Tocilizumab therapy in patients with cytokine storm of severe corona virus disease (COVID-19) pneumonia. This is a parallel study with enrolment in 3:1 ratio. Standard of care will be given in both arms as per the Clinical Management Protocol of ICMR, Ministry of Health and Family Welfare, Government of India.

 
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