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CTRI Number  CTRI/2020/12/030049 [Registered on: 28/12/2020] Trial Registered Prospectively
Last Modified On: 24/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A RETROSPECTIVE OBSERVATIONAL STUDY IN COVID-19 PATIENTS ADMITTED TO THE ICU TO SEE WHETHER DERANGEMENT OF VARIOUS BIOMARKERS IN PATIENT BLOOD TESTS CORRELATE WITH THE OUTCOME OF THEIR ILLNESS. 
Scientific Title of Study   CORRELATION OF PATIENTS PROFILE AND BIOMARKERS WITH OUTCOMES IN COVID-19 ICU PATIENTS: A RETROSPECTIVE ANALYSIS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Kohli  
Designation  Associate Professor  
Affiliation  Maulana Azad Medical college 
Address  Department of Anesthesiology and Intensive care, 3rd floor, BL Taneja Block, Maulana Azad Medical college, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9818073402   
Fax    
Email  dramitkohli@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kohli  
Designation  Associate Professor  
Affiliation  Maulana Azad Medical college 
Address  Department of Anesthesiology and Intensive care, 3rd floor, BL Taneja Block, Maulana Azad Medical college, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9818073402   
Fax    
Email  dramitkohli@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Karthik K Raman 
Designation  Post graduate Junior resident doctor 
Affiliation  Maulana Azad Medical college 
Address  C/O Dr. Amit Kohli, Department of Anesthesiology and Intensive care, 3rd floor, BL Taneja Block, Maulana Azad Medical college, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone    
Fax    
Email  raman.karthik.in@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and critical care, Maulana Azad medical college 
 
Primary Sponsor  
Name  Maulana Azad Medical college  
Address  Department of Anesthesiology and Intensive care, 3rd Floor, BL Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002  
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 
Dr Karthik K Raman  Lok Nayak Hospital  DEDICATED COVID19 ICUS 2 AND 5 OF LOK NAYAK HOSPITAL
Central
DELHI 		 9650464120

raman.karthik.in@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and associated Lok Nayak, G.I.P.M.E.R & Guru Nanak Eye centre Hospitals  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  14.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ALL PATIENTS WITH LABORATORY CONFIRMED COVID19 ADMITTED TO THE INTENSIVE CARE UNIT UNDER OUR OBSERVATION DURING THE STUDY PERIOD 
 
ExclusionCriteria 
Details  THERE ARE NO EXCLUSION CRITERIA FOR THIS OBSERVATIONAL STUDY 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
SURVIVAL OF PATIENTS  BASELINE DATA COLLECTED AT TIME OF ADMISSION TO THE ICU

COURSE OF ILLNESS AND OUTCOME NOTED AT THE TIME OF DISCHARGE FROM THE ICU (RECOVERY) OR DEATH 
 
Secondary Outcome  
Outcome  TimePoints 
PROPORTION OF PATIENTS REQUIRING INVASIVE OR NON-INVASIVE MECHANICAL VENTILATION  NOTED AT THE TIME OF DISCHARGE FROM THE ICU (RECOVERY) OR DEATH 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/01/2021 
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="0"
Months="3"
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   COVID19 is a novel disease with a highly variable and unpredictable course. The pandemic is overwhelming limited intensive care resources. There is an acute need to gather and analyse clinico-demographic profiles of patients to determine the risk factors for severe illness so as to triage patients for intensive care and provide early aggressive care to at-risk patients. Various clinico-demographic indicators and numerous biomarkers have been identified as possible predictors of severe illness in western studies. There is paucity of data regarding Indian COVID19 patients.

This is a retrospective observational study in COVID19 patients admitted to the dedicated COVID ICUs of our institution from 1st May 2020 to 1st August 2020. This will be a cross sectional study performed at multiple time points.

The data will be used to describe the clinical and demographic profiles of Indian COVID19 patients with severe illness requiring intensive care.

We wish to estimate the association between values of various biomarkers of inflammation (including serum lactate dehydrogenase , serum ferritin, serum Interleukin 6, C-reactive protein, neutrophil-lymphocyte ratio, D-dimers) with survival. 

We also aim to estimate the association between various biomarker data and patient demographics (including age, sex, co-morbidities), blood oxygen levels (measured with PaO2:FiO2 ratio) and need for non-invasive or invasive mechanical ventilatory support. 
 
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