| CTRI Number |
CTRI/2022/02/040137 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
08/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
Severity of Covid-19 infection in patients with comorbidities |
|
Scientific Title of Study
|
To correlate Covid-19 outcome in patients with comorbidities
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
YASHIF N A |
| Designation |
DNB resident (primary) |
| Affiliation |
Max superspeciality Hospital , shalimarbagh |
| Address |
Emergency Department
Max Superspeciality Hospital
Shalimarbagh
North West
DELHI
110088
India |
| Phone |
9961282517 |
| Fax |
|
| Email |
yashifbava2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Kishalay Datta |
| Designation |
Director, emergency and Trauma |
| Affiliation |
Max superspeciality Hospital , shalimarbagh |
| Address |
Emergency Department
Max Superspeciality hospital
Shalimarbagh
North West
DELHI
110088
India |
| Phone |
8178194448 |
| Fax |
|
| Email |
dr.kishalay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yashif N A |
| Designation |
DNB resident (primary) |
| Affiliation |
Max superspeciality Hospital , shalimarbagh |
| Address |
Emergency Department
Max SuperSpeciality Hospital
Shalimrbagh
North West
DELHI
110088
India |
| Phone |
9961282517 |
| Fax |
|
| Email |
yashifbava2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Superspeciality Hospital Shalimarbagh NewDelhi- 110088 |
|
|
Primary Sponsor
|
| Name |
Department of Emergency Medicine |
| Address |
Max Superspeciality Hospital Shalimarbagh NewDelhi- 110088 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| YASHIF N A |
MAX SuperSpeciality Hospital |
Emergency Medicine Casualty
Department Of Medicine
Max Superspeciality Hospital Shalimarbagh NewDelhi - 110088
North West
DELHI |
9961282517
yashifbava2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAX HEALTH CARE ETHICS COMMITTEE |
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, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who will be hospitalized via the emergency room ( confirmed COVID19 (positive real-time reverse transcriptase–polymerase chain reaction [RT-PCR] assay of a nasopharyngeal swab and rapid antigen test(RAT) nasal swab will be included )
2) Patients with age more than 18 years old will be included
3) Patients with history of chronic diseases: hypertension, diabetes, coronary heart disease, chronic cerebrovascular disease, chronic respiratory disease (asthma, COPD), chronic hepatitis, chronic kidney disease and cancer will be included
4) Obese patient
|
|
| ExclusionCriteria |
| Details |
1) Pregnant patients will be excluded
2) Patients with no comorbidity will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To correlate covid -19 outcome in patients according to number of comorbidities- one and more than one: two, three, four, five, six
|
ONE YEAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess clinical signs and symptoms, laboratory findings among patients with different types of single comorbidities: obesity, hypertension, diabetes, COPD, CAD, CLD ,CKD CVA and cancer |
ONE YEAR |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
11/02/2022 |
| 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="1"
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
|
Primarly this study is used for Post Graduate Thesis purpose , in order to evaluate the severity of corona virus infection impacting on patients with different comorbidities .Also we can evaluate which comorbidity is having is more risk to corona virus infection , length of hospital stay , duration and mortality rate
|