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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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 
 
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