CTRI Number |
CTRI/2021/05/033446 [Registered on: 07/05/2021] Trial Registered Prospectively |
Last Modified On: |
19/09/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Study to estimate the risk factors associated with deaths due to COVID-19 infection |
Scientific Title of Study
|
Mortality in patients with Covid-19 in a tertiary center in North Kerala : clinical , demographic and laboratory parameters |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Manu Mathews |
Designation |
Associate Professor |
Affiliation |
Government Medical College Kannur,kerala |
Address |
Dhanya House,
Makuni Road,
Pallikkunnu ,
Kannur,
Kerala,
India 4th floor,
Room 406
Department of Medicine
Government Medical College, kannur,Kerala Kannur KERALA 670004 India |
Phone |
08156991383 |
Fax |
|
Email |
manumathews123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manu Mathews |
Designation |
Associate Professor |
Affiliation |
Government Medical College Kannur,kerala |
Address |
Dhanya House,
Makuni Road,
Pallikkunnu
Kannur District 4th floor,
Room 406
Department of Medicine
Government Medical College Kannur, Kerala Kannur KERALA 670004 India |
Phone |
08156991383 |
Fax |
|
Email |
manumathews123@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manu Mathews |
Designation |
Associate Professor |
Affiliation |
Government Medical College Kannur,kerala |
Address |
Dhanya House
Makuni Road
Pallikkunnu
Kannur District 4 th floor
Room 406
Department of Medicine
Government medical College kannur
Pin 670503 Kannur KERALA 670004 India |
Phone |
08156991383 |
Fax |
|
Email |
manumathews123@gmail.com |
|
Source of Monetary or Material Support
|
Government medical College Kannur Kerala |
|
Primary Sponsor
|
Name |
Dr Manu Mathews |
Address |
Dhanya, Makuni road, Pallikkunnu , Kannur, Kerala, PIN 670004 |
Type of Sponsor |
Other [Sponsored by the principal investigator , Dr Manu Mathews] |
|
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 Manu Mathews |
Government Medical College,. Kannur , Pariyaram , kerala |
4th floor
Room 406
Department of Medicine
Pariyaram , kannur District
Pin 670503
Kannur KERALA |
8156991383
manumathews123@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Government Medical College, Kannur |
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 |
All patients aged more than 18 yrs with documented covid-19 infection and expired during their hospital stay in the study period |
|
ExclusionCriteria |
Details |
Patients with documented covid -19 infection but expired due to causes definitely other than covid -19 like suicides , accidents etc |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the demographic, clinical and laboratory parameters of patient expired due to covid-19
To study the comorbidities and complications of patients expired due to the covid-19 infection |
Retrospective study with study period April 1,2020 to March 31, 2021 (1 year ) |
|
Secondary Outcome
|
Outcome |
TimePoints |
.nil |
.nil |
|
Target Sample Size
|
Total Sample Size="450" Sample Size from India="450"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/05/2021 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Mortality in covid-19 - clinical, demographic and laboratory parameters |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Study design : Descriptive cross sectional record based study The study estimates various parameters in covid -19 deaths from data available in medical records section of government Medical College Kannur. The study centre is the only major tertiary centre managing category C covid 19 patients for 2 districts , kannur and Kasargode in North Kerala. Purpose is to identify the age group , lab parameters and the comorbidities in covid-19 deaths so as to streamline the preventive and treatment measures to the vulnerable group |