| CTRI Number |
CTRI/2020/08/027246 [Registered on: 19/08/2020] Trial Registered Prospectively |
| Last Modified On: |
09/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cohort 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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. |