| CTRI Number |
CTRI/2020/12/029454 [Registered on: 01/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Study |
| Study Design |
Other |
|
Public Title of Study
|
Severity of COVID among type 2 diabetes patients |
|
Scientific Title of Study
|
Study on characteristics and prognosis of diabetes and non diabetes patients with COVID 19 among southern Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IDRFARH015 Version 2.0 dated 12.11.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambady Ramachandran |
| Designation |
President |
| Affiliation |
India Diabetes Research Foundation |
| Address |
Department of Diabetology
Research Division
Room No: 1
India Diabetes Research Foundation
No:3 & 4, Montieth Road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
|
| Fax |
|
| Email |
research@ardiabetes.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambady Ramachandran |
| Designation |
President |
| Affiliation |
India Diabetes Research Foundation |
| Address |
Department of Diabetology
Research Division
Room No: 1
India Diabetes Research Foundation
No:3 & 4, Montieth Road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
|
| Fax |
|
| Email |
research@ardiabetes.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambady Ramachandran |
| Designation |
President |
| Affiliation |
India Diabetes Research Foundation |
| Address |
Department of Diabetology
Research Division
Room No: 1
India Diabetes Research Foundation
No:3 & 4, Montieth Road, Egmore
Chennai
TAMIL NADU
600008
India |
| Phone |
|
| Fax |
|
| Email |
research@ardiabetes.org |
|
|
Source of Monetary or Material Support
|
| India Diabetes Research Foundation
No 3 and 4
Montieth Road
Egmore
Chennai 600008 |
|
|
Primary Sponsor
|
| Name |
India Diabetes Research Foundation |
| Address |
No 3 and 4 Montieth Road Egmore Chennai 600008 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sruti Chandrasekaran |
Dr.Rela Institute & Medical Centre |
Room No 1
Department of Endocrinology
Research Division
7, CLC Works Road, Chromepet
Chennai
TAMIL NADU |
9380002734
research@ardiabetes.org |
| Dr T Palaniappan |
Medway Hospital |
Room No 1
Department of Medicine
Research Division
No 2 26, 1st Main Road, United India Company,
Kodambakkam
Chennai
TAMIL NADU |
9841026161
satresearch01@gmail.com |
| Dr A Subair Khan |
Orthomed Hospital |
Room No 1
Department of Medicine,
Research Division,
83 & 85, Royapettah High Road,
Royapettah
Chennai
TAMIL NADU |
9840299222
idrf.research@gmail.com |
| Dr Su Thillai Vallal |
Venkateswara Hospital |
Room No 1
Department of Medicine,
Research Division
No: 36-A, Chamiers Road, Nandanam
Chennai
TAMIL NADU |
9176335677
satmgmc69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Dr Rela Institute and Medical Center |
Approved |
| Ethics Committee of India Diabetes Research Foundation and Dr.A.Ramachandrnas Diabetes Hospitals |
Approved |
| Ethics Committee of India Diabetes Research Foundation and Dr.A.Ramachandrnas Diabetes Hospitals |
Approved |
| Ethics Committee of India Diabetes Research Foundation and Dr.A.Ramachandrnas Diabetes Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (2) 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 |
>18 yrs male or female
COVID-19 positive
|
|
| ExclusionCriteria |
| Details |
COVID 19 Negative
New-onset Diabetes with covid-19 infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of patients who were in ICU |
14 days |
| Number of patients who had tracheal intubation |
14 days |
| Number of patients who had respiratory complication |
14 days |
| Number of death |
14 days |
| Length of hospital stay |
14 days |
| No. of patients recovered and discharged |
14 days |
| • No. of patients who developed complications during the disease period (retinopathy, nephropathy, neuropathy, ischemic heart disease, cerebrovascular disease, peripheral artery disease, diabetic foot ulcer, hypertension, dyslipidemia) |
14 days |
| Pattern of treatment for coexisting diabetes, hypertension, dyslipidemia and coronary artery disease |
14 days |
|
|
Target Sample Size
|
Total Sample Size="1050"
Sample Size from India="1050"
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)
|
26/11/2020 |
| 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="6"
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
following data from a person tested positive for COVID 19 and hospitalized will
be collected. Patient’s anthropometry (height in cms, weight in kgs, and body mass index in kg/m2), blood pressure, symptoms of COVID-19 (fever,
fatigue, cough, cephalalgia, dyspnoea, rhinitis, pharyngeal symptoms, ageusia,
anosmia, digestive disorders), history of
smoking, hypertension, dyslipidemia, microvascular (retinopathy, nephropathy
and neuropathy), macrovascular (coronary artery disease, cerebrovascular
disease and peripheral vascular disease) complications and other comorbid
conditions will be recorded. Fasting blood glucose, HbA1c, and any other
relevant investigations if available and treatment for COVID-19 and other co
morbid conditions will be recorded.
Details
of patients developing new symptoms, shifted to ICU, intubated, or died during
the course of treatment will be recorded. The appearance of any complication during
the stay at the hospital will be recorded. The changes in the treatment pattern
during the course of the disease will also be noted.
The registry will be fully anonymized and statisticians will have no
access to patients’ personal identifiers. All “investigators†will have to
register before entering data in the registry. Data about clinical observations
for the individual patient will be entered by clinicians or by authorized
research personnel of the care team in the registry.
Patients’ names, dates of birth, date of death,
residential postal code, hospital number will be fully anonymized at the source. In
no circumstances, patients’ identifiable data be available to anyone outside
their own care teams or authorized local administration/research personnel. Patient
data will not at any stage be in identifiable form by the registry
managers. The data to be collected from the patients are mentioned in the visit
chart. |