| CTRI Number |
CTRI/2020/12/029882 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
16/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Socio demographic profile and clinical outcome in COVID 19 in a tertiary care hospital -A Retrospective study |
|
Scientific Title of Study
|
Socio-Demographic profile and clinical outcomes in COVID 19 in a tertiary care hospital -A Retrospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PunithaVC |
| Designation |
Consultant- Clinical Research |
| Affiliation |
SRM Institutes for Medical Science |
| Address |
Department of Clinical Research, Room No 5, B Block,
No 1 Jawaharlal Nehru Salai
Vadapalani
Chennai
TAMIL NADU
600026
India |
| Phone |
9884052066 |
| Fax |
|
| Email |
drpunitha77@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PunithaVC |
| Designation |
Consultant- Clinical Research |
| Affiliation |
SRM Institutes for Medical Science |
| Address |
Department of Clinical Research, Room No 5, B Block,
No 1 Jawaharlal Nehru Salai
Vadapalani
Chennai
TAMIL NADU
600026
India |
| Phone |
9884052066 |
| Fax |
|
| Email |
drpunitha77@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr PunithaVC |
| Designation |
Consultant- Clinical Research |
| Affiliation |
SRM Institutes for Medical Science |
| Address |
Department of Clinical Research, Room No 5, B Block,
No 1 Jawaharlal Nehru Salai
Vadapalani
Chennai
TAMIL NADU
600026
India |
| Phone |
9884052066 |
| Fax |
|
| Email |
drpunitha77@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SRM Institutes Of Medical Science. Vadapalani, Chennai 600026 |
|
|
Primary Sponsor
|
| Name |
SRM Institutues for Medical Science |
| Address |
No 1, Jawaharlal Nehru Salai, 100 feet road, Vadapalani, pincode: 600026 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Punitha |
SRM Institutes for Medical Science |
Department Of clinical Research, Room No 5, B Block,
vadapalani, Chennai.
Chennai
TAMIL NADU |
9884052066
drpunitha77@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- SRM Institutes for Medical Science |
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
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL: |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients testing positive for COVID 19 |
|
| ExclusionCriteria |
| Details |
Less than 18 years |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Social Demographic Profile and Clinical Outcome in COVID patients |
June 29th to Oct 31st 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Case Fatality Rate Calculation |
June 29th to Oct 31st 2020 |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
21/12/2020 |
| 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
|
The study objectives are 1) To describe the sociodemographic profile and case fatality rate among COVID 19 patients using retrospective data of the hospital. 2) To describe the hospital preparedness to tackle the COVID 19 pandemic.
After collecting the data from the medical records, the analysis will be done using the appropriate statistical methods.. |