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CTRI Number  CTRI/2020/05/025369 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 23/09/2020
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 study on treatment of COVID-19 patients with study drug along with standard of care 
Scientific Title of Study   A Multi-center, Randomized Controlled, Phase III Study to evaluate the Clinical Outcomes and Safety of Tocilizumab along with Standard of Care in Patients with Cytokine Release Syndrome associated with COVID-19 infection  
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
TCZ/COVID-19/01/2020 Version 2.0 dated 05 May 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arvinder Soin 
Designation  National lead Investigator 
Affiliation  Medanta Institute of Education and Research (MIER) 
Address  Medanta-The Medicity Sector – 38, Gurgaon, Haryana-122001, India

Gurgaon
HARYANA
122001
India 
Phone  01244855100  
Fax  01244834111  
Email  avisoin1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pooja Sharma 
Designation  Senior Scientist and Head MIER 
Affiliation  Medanta Institute of Education and Research (MIER) 
Address  Medanta-The Medicity Sector-38, Gurgaon, Haryana-122001, India

Gurgaon
HARYANA
122001
India 
Phone  01244855100  
Fax  01244834111  
Email  pooja.sharma@medanta.org  
 
Details of Contact Person
Public Query
 
Name  Kuldeep K Chauhan  
Designation  Senior Clinical Project Leader- Research Operations 
Affiliation  Medanta Institute of Education and Research (MIER) 
Address  Medanta-The Medicity Sector-38, Gurgaon, Haryana-122001, India

Gurgaon
HARYANA
122001
India 
Phone  09971918887  
Fax  01244834111  
Email  Kuldeep.chauhan@medanta.org  
 
Source of Monetary or Material Support  
Medanta Institute of Education and Research (MIER) Medanta-The Medicity Sector – 38, Gurgaon, Haryana- 122001, India 
 
Primary Sponsor  
Name  Medanta Institute of Education and Research MIER 
Address  Medanta-The Medicity Sector – 38, Gurgaon, Haryana- 122001, India 
Type of Sponsor  Research institution and hospital 
 
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 Suneetha Narreddy  Apollo Hospitals- Hyderabad  Department of Infectious Diseases, Room No: 48, Old MHC Block, Ground Floor, Apollo Hospitals, Jubilee Hills, Hyderabad, Telangana-500096, India
Hyderabad
TELANGANA 
09966022225
04023607777
suneethanareddy@hotmail.com 
Dr D Suresh Kumar  Apollo Speciality Hospitals-Vanagaram  Infectious Disease Department, Block -B, 5th Floor, Apollo Speciality Hospitals, Plot No 64, Vanagaram-Ambattur Road, Ayanambakkam, Kilayanambakkam, Chennai-600095, Tamil Nadu, India
Chennai
TAMIL NADU 
09444186807
04428296784
dskinfdis@gmail.com 
Dr Reshma Tewari   Artemis Hospital  ICU-I, First Floor, Artemis Hospital, Sector-51, Gurugram-122001, Haryana, India
Gurgaon
HARYANA 
09958402254
01246767708
reshma@artemishospitals.com 
Dr Shashikala A Sangle  B J Medical College and S G H B J Medical College and Sassoon General Hospital  Department Of Medicine, 3rd Floor, B J Medical College and S G H B J Medical College and Sassoon General Hospital Jai Prakash Narayan Road Pune, Maharashtra - 411001 India
Pune
MAHARASHTRA 
09822874712
02026102312
shashisangle@yahoo.com 
Dr Rahul Anil Pandit  Fortis Hospitals Limited Mulund  Intensive Care Unit, Level 2, High Dependency Unit, Department, Fortis Hospitals Limited Mulund, Goregaon Link Road, Bhandup-West Mumbai- 400078, Maharashtra, India
Mumbai
MAHARASHTRA 
09606047050
02243654365
rahul.pandit@fortishealthcare.com 
Dr Manoj Kumar Goel  Fortis Memorial Research Institute  Department of Pulmonology, Lower Ground Floor, Room No 1, Fortis Memorial Research Institute, Sector - 44, Opposite HUDA City Centre Gurgaon, Haryana - 122002, India
Gurgaon
HARYANA 
09560468800
0124716222
manoj.goel@fortishealthcare.com 
Dr Rajesh Chawla  Indraprastha Apollo Hospitals  Department of Respiratory, Room No 4221, 3rd Floor, Indraprastha Apollo Hospitals Sarita Vihar, Delhi – Mathura Road, New Delhi – 110076, India
New Delhi
DELHI 
09810033395
01129871090
drchawla@hotmail.com 
Dr Mohd Tariq Ali  Medanta- The Medicity  Sector -38, Gurgaon- 122001, Haryana, India
Gurgaon
HARYANA 
09871982816

Tariq.ali@medanta.org 
Dr Sushila Kataria  Medeor Hospital  Department Name- Critical Care, Room No- 84, Block No-1, Ground floor, Manesar, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA 
09818828078
01244141414
drsushilakataria@gmail.com 
Dr Vipul Mishra  Nayati Hospital   Department of pulmonology and critical care, Nayati Medicity, Near CNG Pump, NH 2, Mathura-281001, Uttar Pradesh And Nayati Hospital,Near Sikandra, NH-19, Agra, UP, 2811071, India
Agra
UTTAR PRADESH 
09811190105
01204345509
vpcare@gmail.com 
Dr Lancelot Pinto  P. D. Hinduja Hospital and Medical Research Centre  Dept of Pulmonary Medicine (PFT department) Room no 3307 OPD building (East block), 3rd Floor, P D Hinduja National Hospital and Medical Research Centre, Veer Savarkar Marg Mahim, Mumbai-400016, India
Mumbai
MAHARASHTRA 
09820234567
024449151
lance.pinto@gmail.com 
Dr Dhruva Chaudhry  Pt. B. D. Sharma Post Graduate Institute of Medical Sciences  Department of Pulmonary & Critical Care Medicine, Emergency building, in front of ward 3, ground floor, Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana-124001, India
Rohtak
HARYANA 
09991101616

dhruvachaudhry@yahoo.co.in 
Dr Vikas Agarwal   Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Clinical Immunology & Rheumatology, Room No 3, C block, Ground Floor, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, Uttar Pradesh 226014, India
Lucknow
UTTAR PRADESH 
09793245857

vikasagr@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Artemis Health Sciences IEC Artemis Hospital  Submittted/Under Review 
IEC of B J G M C and Sassoon General Hospital, B.J G M C and Sassoon General Hospital  Submittted/Under Review 
Institutional Ethics Committee – Clinical Studies Indraprastha Apollo Hospitals  Submittted/Under Review 
Institutional Ethics Committee Fortis Hospitals Limited- Mulund  Approved 
Institutional Ethics committee P D Hinduja Hospital & Medical Research Centre  Submittted/Under Review 
Institutional Ethics Committee, Fortis Memorial Research Institute  Submittted/Under Review 
Institutional Ethics Committee, Pt. B.D. Sharma PGIMS/UHS  Approved 
Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee-Apollo Research and Innovations, Jubilee Hills Apollo Health City  Submittted/Under Review 
Institutional Ethics Committee-Clinical Studies Apollo Hospitals Enterprises Limited  Approved 
Medanta Institutional Ethics Committee  Approved 
Medanta Institutional Ethics Committee  Approved 
Nayati Multi Super Specialty Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Current Standard of Care  Standard of CARE will be as per individual Hospital (Study Site) Policy  
Intervention  Tocilizumab and Current Standard of Care  Dose: 6 mg/kg (up to a maximum of 480 mg), Frequency: Once, Route of Administration: Intravenous Infusion, Total duration of administration: 1 Hour and Standard of CARE will be as per individual Hospital (Study Site) Policy  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  I. Male or female subjects who are ≥18 years of age, on the day of signing informed consent.
II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure.
III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid).
IV. Moderate to severe COVID 19 infection (moderate disease – increased respiratory rate 15 to 30/minute and SpO2 90%-94%; and severe disease - respiratory rate ≥ 30/minute and/or SpO2 < 90% on room air, or ARDS or Septic shock
 
 
ExclusionCriteria 
Details  I. Known severe allergic reactions to TCZ or other monoclonal antibodies
II. Active tuberculosis (TB) infection.
III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19).
IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months.
VI. Participating in other drug clinical trials
VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient safe participation in and completion of the study.
X. Definite diagnosis of rheumatic immune related diseases.
XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline
XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline
XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects showing progressive COVID 19 disease from moderate to severe, or from severe disease to death   Up to Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to clinical improvement (TTCI),defined as a National Early Warning SCORE2(NEWS2) of lesser and equal to 2, maintained for 24 hours
2.Proportion of subjects showing Improvement (≥1 grade) of CRS
3.Incidence of Mechanical Ventilation
4.Ventilator Free days to day 28
5.Organ Failure-free days to day 28
6.Incidence of Intensive Care (ICU) stay
7.Duration of ICU stay
8.ICU free days
9.Time to Clinical Improvement of COVID-19 grade
10.Mortality rate 
1.Upto 28 Days
2.Upto 28 Days
3.Upto 28 Days
4.Upto Day 28
5.Upto Day 28
6.Upto 28 days
7.Upto 28 days
8.Upto 28 days
9.Upto 28 days
10.Days 7, 14, 21 and 28 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/05/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Brief Summary  

This is a multicentric, randomized, phase III to evaluate the Clinical Outcomes and Safety of Tocilizumab (TCZ) along with standard of care in patients with cytokine release syndrome associated with moderate to severe COVID-19 infection. A total of 180 patients (90 in each arm) will be enrolled in study. The enrolment period of the study will be approximately 3 months and total duration of the study will be approximately 5 months. For an individual patient, duration of the study will be approximately 30 days, including 7 study visits. In both arms, patients will be provided the Standard of care (SOC) for COVID 19 as per the protocol of the particular hospital setup (Study site). Each patient will be monitored closely throughout his/her hospitalization for the COVID -19 and will be followed for 30 days from randomization.


 
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