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CTRI Number  CTRI/2021/06/034469 [Registered on: 30/06/2021] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   PROSPECTIVE 
Study Design  Single Arm Study 
Public Title of Study   Cardiac Effects In Moderate To Severe COVID-19 Patients Receiving Treatment In Critical Care Unit Of A Tertiary Care Hospital, West Bengal  
Scientific Title of Study   Cardiovascular Manifestation In Moderate To Severe COVID-19 Patients Undergoing Treatment In Critical Care Unit Of A Tertiary Care Hospital, West Bengal And Role Of Portable, Point Of Care Cardiac Biomarker Autoanalyzer In Their Early Diagnosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asim Kumar Kundu 
Designation  Professor Head, Anesthesiology 
Affiliation  Medical College Kolkata 
Address  Medical College Hospital 88, College Street Green Building 3rd Floor
88 College Street Kolkata 700073
Kolkata
WEST BENGAL
700037
India 
Phone  8910112128  
Fax    
Email  drkunduasim@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ASIM KUMAR KUNDU 
Designation  Professor Head, Anesthesiology 
Affiliation  Medical College Kolkata 
Address  Medical College Hospitals Green Building 3rd Floor
88 College Street Kolkata 700073
Kolkata
WEST BENGAL
700037
India 
Phone  8910112128  
Fax    
Email  drkunduasim@gmail.com  
 
Details of Contact Person
Public Query  
Name  ASIM KUMAR KUNDU 
Designation  Professor Head, Anesthesiology 
Affiliation  Medical College Kolkata 
Address  Medical College Hospitals Green Building 3rd Floor
88 College Street Kolkata 700073
Kolkata
WEST BENGAL
700037
India 
Phone  8910112128  
Fax    
Email  drkunduasim@gmail.com  
 
Source of Monetary or Material Support  
Medical College Kolkata 88, College Street Kolkata 700073 
 
Primary Sponsor  
Name  MEDICAL COLLEGE KOLKATA 
Address  88, College Street 
Type of Sponsor  Government medical college 
 
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 
Swati Dutta  MEDICAL COLLEGE KOLKATA CCU SSB AND GREEN  SSB Building 2nd floor 3rd floor Green Building 3rd floor Department of Anesthesiology 88, COLLEGE STREET KOLKATA 700073
Kolkata
WEST BENGAL 		 8910112128

drslahiri11@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  
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  80.00 Year(s)
Gender  Both 
Details  Laboratory confirmed COVID-19 patients
SpO2 <94%
Patients on different modalities of oxygen therapy
Patients with radiologically confirmed pneumonia
Suffering from ARDS / Acute Respiratory Failure 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Discharge from CCU
All cause mortality 		 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Association between existing cardiac disease or new onset cardiac manifestations among Covid infected patients.  28 days 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/07/2021 
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="2"
Months="0"
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   Hospitalised patients admitted with fever, cough, sore throat and/ dyspnoea who will be tested positive for SARS COV-2 and have moderate to severe disease activity will be included in our study. The electronic medical charts of the study subjects will be reviewed and relevent demographic, clinical, laboratory and imaging findings will be de-identified and recorded. Demographic characteristics including age at the time of diagnosis, gender, race, BMI will be collected. Past medical history including coronary artery disease, heart failure with reduced or preserved left ventricular Ejection Fraction, AF, Hypertension, Dyslipidemia, DM, Smoking history as well as history of regular medication will be ascertained.  Laboratory investigation for Cardiac biomarkers like Troponin I, BNP, Pro BNP, CPK, CPKMB and other investigations like D dimer, Serum electrolytes, Hemoglobin, Creatinine, Lactate will be collected. Available EKG, TTE will be individually reviewed by an independent cardiology faculty or fellow. The incidence and relative frequencies of different cardiovascular disease manifestations occurring denovo among the moderate to severely affected Covid patients at Intensive care facility will be noted. Finally clinical outcomes including need for mechanical ventilation, length of ICU/CCU stay, length of hospilalisation, arrythmias, cadiac arrest and in hospital mortality will be abstracted. 
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