| CTRI Number |
CTRI/2020/09/027686 [Registered on: 09/09/2020] Trial Registered Prospectively |
| Last Modified On: |
09/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine whether diabetes in COVID-19 patients is associated with more complications. |
|
Scientific Title of Study
|
Outcome of Diabetes patients in COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shams Kanuga |
| Designation |
2nd Year Resident Doctor in Department of General Medicine |
| Affiliation |
GCS Hospital, Medical College and Research Centre |
| Address |
Department of General Medicine, GCS Hospital, Medical College
and Research Centre, opposite DRM Office, near Chamunda Bridge,
Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429331221 |
| Fax |
|
| Email |
shamskanuga293@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shams Kanuga |
| Designation |
2nd Year Resident Doctor in Department of General Medicine |
| Affiliation |
|
| Address |
Department of General Medicine, GCS Hospital, Medical College
and Research Centre, opposite DRM Office, near Chamunda Bridge,
Naroda Road, Ahmedabad
GUJARAT
380025
India |
| Phone |
9429331221 |
| Fax |
|
| Email |
shamskanuga293@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shams Kanuga |
| Designation |
2nd Year Resident Doctor in Department of General Medicine |
| Affiliation |
GCS Hospital, Medical College and Research Centre |
| Address |
Department of General Medicine, GCS Hospital, Medical College
and Research Centre, opposite DRM Office, near Chamunda Bridge,
Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429331221 |
| Fax |
|
| Email |
shamskanuga293@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Hospital, Medical College and Research Centre, opposite DRM Office, near Chamunda
Bridge, Naroda Road, Ahmedabad 380025 |
|
|
Primary Sponsor
|
| Name |
GCS Hospital Medical College and Research Centre |
| Address |
Opposite DRM Office, near Chamunda Bridge, Naroda Road,
Ahmedabad, Gujarat |
| 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 Shams Kanuga |
GCS Hospital, Medical College and Research Centre |
Covid-19 Ward(7th
floor) and ICU(Ground
Floor), Department of
General Medicine
Ahmadabad
GUJARAT |
9429331221
shamskanuga293@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, (2) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
COVID-19 positive patients and Newly detected or known case of diabetes.
Non-diabetic patients will be taken as control group |
|
| ExclusionCriteria |
| Details |
age less than 18 years.
COVID-19 negative patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of COVID-19 patients with diabetes compared to non-diabetic patients in terms of mortality, complications and length of hospital stay. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mortality Predictors and Strength of Association
in Covid-19 Patients |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/09/2020 |
| 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="8"
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
|
This Study will be helpful to know the relation of COVID-19 patients with DIabetes in terms of death, complications and length of hospital stay. This relation will help in better COVID-19 patients management, mainly critical patients in ICU. It will predict risk of Motality in diabetic patients with Covid-19. |