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CTRI Number  CTRI/2021/01/030241 [Registered on: 05/01/2021] Trial Registered Prospectively
Last Modified On: 22/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Pattern of COVID 19 infection in different age groups 
Scientific Title of Study   Comparative study of COVID 19 infection in young, middle aged and old patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhalendu Vaishnav 
Designation  Professor and Head 
Affiliation  Pramukhswami Medical College, Karamsad 
Address  Department of Medicine, Pramukhswami Medical College, Karamsad
Pramukhswami Medical College, Karamsad
Anand
GUJARAT
388325
India 
Phone  02692228171  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhalendu Vaishnav 
Designation  Professor and Head 
Affiliation  Pramukhswami Medical College, Karamsad 
Address  Department of Medicine, Pramukhswami Medical College, Karamsad
Pramukhswami Medical College, Karamsad
Anand
GUJARAT
388325
India 
Phone  02692228171  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Umang Patel 
Designation  First year postgraduate student 
Affiliation  Pramukhswami Medical College, Karamsad 
Address  Department of Medicine, Pramukhswami Medical College, Karamsad
Pramukhswami Medical College, Karamsad
Anand
GUJARAT
388325
India 
Phone  8488898740  
Fax    
Email  umang96.uj@gmail.com  
 
Source of Monetary or Material Support  
Pramukhswami Medical College 
 
Primary Sponsor  
Name  Pramukhswami Medical College 
Address  Department of Medicine Pramukhswami Medical College, Karamsad 
Type of Sponsor  Private 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 Bhalendu Vaishnav  Pramukhswami Medical College  COVID Isolation ward, COVID designated Hospital_Shree Krishna Hospital, Karamsad
Anand
GUJARAT 
9825717481

bhalendusv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC_2 HMPATELCENTRE OF_MEDICALCARE_EDUCATION_KARAMSAD  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, (2) ICD-10 Condition: J101||Influenza due to other identifiedinfluenza virus with other respiratory manifestations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients who are COVID-19 positive by RT-PCR/ Rapid Antigen Test and admitted at COVID isolation areas of Shree Krishna Hospital, Karamsad will be included in this study. 
 
ExclusionCriteria 
Details  Any patient admitted as suspect-Covid in isolation area, but found to be RT-PCR negative.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine and compare clinical, biochemical and radiological profile of young ( 18-35 years), middle aged(36-64 years)and old ( 64 years) admitted patients of COVID 19, their correlation with various comorbidities, and their outcome.  Baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To characterise and contrast COVID 19 features in patients of different age  Baseline, during the course of illness and _at the time of discharge/death 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/01/2021 
Date of Study Completion (India) 31/05/2021 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

1.1  Need for the study: As a government designated COVID centre, our institution is catering to a large population suffering from COVID 19. There is a need to study the clinical, biochemical spectrum of COVID 19 patients that we treat so as to add to the available knowledge in this area. Study of all patients admitted upto 31st August has already been undertaken by one of the co-investigators. The present study will help us to expand the cohort and give insight into changing clinical pattern of the disease as the epidemic continues to extend. Furthermore, there is also a need to analyze whether the clinical spectrum differs in patients of different age groups. There are limited studies which have compared clinical profile in young, middle aged and the old patients.

1.2  Review of literature: The world is experiencing an unprecedented pandemic caused by novel corona virus (Covid 19). As on 1st October, there are 6.31 million estimated patients are suffering from COVID 19 in India as per COVID tracker. Understanding about its pathophysiology, clinical features and therapy is gradually increasing. Symptoms of COVID-19 may range from mild to severe, with sizable yet varied fatality rates of 2.3% in China, 7.2% in Italy, and 1.0% in South Korea. 1 Due to the general susceptibility of new coronaviruses, the clinical characteristics and outcomes of elderly and young patients may be different. The elderly may represent a specific cluster of high-risk patients for developing COVID-19 with rapidly progressive clinical deterioration. Indeed, in older individuals, immunosenescence and comorbid disorders are more likely to promote viral-induced cytokine storm resulting in life-threatening respiratory failure and multi-systemic involvement. 2Kang SJ et al have reported that case fatality rate and susceptibility to symptomatic COVID-19 is higher in the elderly. 3

1.3  Objectives of the present study

To determine and compare clinical, biochemical and radiological profile of young ( 18-35 years), middle aged(36-64 years)and old ( >64 years) admitted patients of COVID 19, their correlation with various comorbidities, and   their outcome.

 

 

  1. Material and method:

 

2.1 Source of data: All patients of COVID 19 admitted in COVID isolation wards of Shree Krishna Hospital, Karamsad from 1st September, 2020 to 31st December, 2020.

2.2 Methodology [brief description]

- Inclusion: All patients who are COVID-19 positive by RT-PCR/ Rapid Antigen Test and admitted at COVID isolation areas of Shree Krishna Hospital, Karamsad will be included in this study.

- Exclusion criteria: All patients admitted as suspect-Covid in isolation area, but found to be RT-PCR negative.

- Data of all patients will admitted during the period of 1st September, 2020 to 31st December 2020 be retrieved from electronic records and its retrospective and prospective analysis will be carried out as regards various clinical, biochemical and radiological parameters  to derive inference about spectrum of disease

Requirement of any investigations or interventions to be conducted on participants - No

2.3 Plan of statistical analysis: Retrospective collection of data.

Descriptive analysis (frequency,%).

Categorical variables will be expressed as numbers and percentages.

Continuous variables will be expressed as mean or median. For the parameters which will be measured multiple times we will estimate the trends.

Association between age, gender, disease severity, complications, co-morbidities, and outcome will be assessed using suitable statistical tests. (Categorical variables – Chi Square test, Continuous Variables – T Test).

 
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