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CTRI Number  CTRI/2020/08/027246 [Registered on: 19/08/2020] Trial Registered Prospectively
Last Modified On: 19/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Role of Tocilizumab in COVID-19 Pneumonia patients  
Scientific Title of Study   Role of Tocilizumab in Patients with Moderate to Severe COVID-19 Pneumonia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jay Shah 
Designation  2nd year Resident Doctor 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD No.1, General Medicine Department, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India 
Phone  7984108807  
Fax    
Email  jayhshah2393@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shaila Shah 
Designation  Associate Professor of General Medicine 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD No.1, Department of General Medicine, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India 
Phone  9825985529  
Fax    
Email  shailashah05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shaila Shah 
Designation  Associate Professor of General Medicine 
Affiliation  GCS Medical College, Hospital and Research Centre 
Address  OPD No.1, General Medicine Department, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India 
Phone  9825985529  
Fax    
Email  shailashah05@gmail.com  
 
Source of Monetary or Material Support  
GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad 
 
Primary Sponsor  
Name  GCS Medical College Hospital and Research Centre 
Address  GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jay Shah  GCS Medical College, Hospital and Research Centre  COVID ICU AND COVID Ward, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT 
7984108807

jayhshah2393@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  RT-PCR COVID-19 Test Positive patients will be included
Moderate to Severe COVID Pneumonia patients will be included
 
 
ExclusionCriteria 
Details  Patients with Active Tuberculosis, Past history of Tuberculosis, Other active suspected Viral/Fungal infection, Platelet count <50,000/ml and Absolute Pneutrophil Count <1000/ml will be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Role of Tocilizumab in COVID-19 Pneumonia  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know the efficacy of Tocilizumab in COVID-19 Pneumonia patients  3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   01/09/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Tocilizumab is a humanized monoclonal antibody against IL-6 receptors. It has a proven role in Cytokine Releasing Syndrome, Rheumatoid Arthritis, and other autoimmune diseases.
COVID-19 virus primarily affects Respiratory system and may cause mild/moderate/severe Respiratory failure. To study the outcome in COVID pneumonia, giving Injectable Tocilizumab, 8mg/kg dosage in patients with moderate to severe COVID-19 Pneumonia. 
 
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