| CTRI Number |
CTRI/2021/01/030573 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand post COVID quality of life |
|
Scientific Title of Study
|
Post Hospital Discharge follow-up of Health-Related Quality of Life (HRQOL) of COVID-19 infected patients. (COVID QOL India) |
| Trial Acronym |
MIER/COVID/QOL/India/001 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MIER/COVID/QOL/India/001 Version: 01 Dated: 14-12-2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushila Kataria |
| Designation |
Senior Director |
| Affiliation |
Medanta The Medicity Gurugram Haryana India |
| Address |
9th Floor Department of Internal Medicine Division Internal Medicine Room No 30
Medanta The Medicity Sector 38 Near Baktawar Chowk Gurgaon Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9818828078 |
| Fax |
|
| Email |
drsushilakataria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Deswal |
| Designation |
Consultant |
| Affiliation |
Medanta The Medicity Gurugram Haryana India |
| Address |
9th Floor Department of Internal Medicine Division Internal Medicine Room No 24
Medanta The Medicity Sector 38 Near Baktawar Chowk Gurgaon Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9992837902 |
| Fax |
|
| Email |
vikas.deswal@medanta.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Sharma |
| Designation |
Associate Director and Head |
| Affiliation |
Medanta Institute of Education and Research |
| Address |
10th Floor Department Medanta Institute of Education and Research Division Clinical Research
Medanta The Medicity Sector 38 Near Baktawar Chowk Gurgaon Haryana
Gurgaon
HARYANA
122001
India |
| Phone |
9811535739 |
| Fax |
|
| Email |
pooja.sharma@medanta.org |
|
|
Source of Monetary or Material Support
|
| Medanta Institute of Education and Research, 10th floor Medanta The Medicity, Sector 38 Gurugram Haryana |
|
|
Primary Sponsor
|
| Name |
Medanta Institute of Education and Research |
| Address |
Medanta The Medicity Sector 38 Gurgaon Haryana |
| Type of Sponsor |
Research institution |
|
|
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 Sushila Kataria |
Medanta The Medicity |
Department of Internal Medicine Division Internal Medicine Room No 30 Ch Baktawar Singh Road Sector 38
Gurgaon
HARYANA |
9818828078
drsushilakataria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Discharged from Medanta-The Medicity hospital after hospitalization for COVID-19 infection
Given consent for subsequent use of his/her personal health data for research purpose |
|
| ExclusionCriteria |
| Details |
Contact details not available or incorrect
Readmission due to COVID infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the post recovery complications in COVID-19 Patients
To determine the clinically significant drop in Quality-of-Life post recovery from COVID-19 infection
To compare the QOL compared by the severity of the initial disease |
2 months for taking follow up
1 month for statistical analysis and writing manuscript for publication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the QOL compared by the severity of the initial disease |
1 month |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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)
|
22/01/2021 |
| 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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a cross sectional study to evaluate quality of life of patients hospitalized for COVID-19 after discharge. Purpose of this study is also to evaluate sequele, morbidity after discharge. Study details not published yet |