| 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
|
|
|
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
|
|
|
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
|
|
|
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. - 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). |