| CTRI Number |
CTRI/2020/12/029755 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess symptoms and quality of life in post covid patients |
|
Scientific Title of Study
|
Assessment and characterisation of symptoms and quality of life in post covid 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 Khushboo Chahwala |
| Designation |
2nd Year PG student |
| Affiliation |
GMERS Medical college and Hospital, gotri |
| Address |
206-TB Chest opd ,department of pulmonary medicine, GMERS hospital, Gotri,Vadodara
206-TB Chest opd ,department of pulmonary medicine, GMERS hospital, Gotri,Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9712231496 |
| Fax |
|
| Email |
khushboochahwala66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand K Patel |
| Designation |
Associate Professor in Department of pulmonary medicine |
| Affiliation |
GMERS Medical college and hospital, gotri |
| Address |
GMERS Medical College and Hospital,Gotri ,Vadodara
GMERS Medical college and hospital,Gotri ,Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9879771079 |
| Fax |
|
| Email |
dranandkpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand k patel |
| Designation |
Associate professor in dept of pulmonary medicine |
| Affiliation |
GMERS Medical college and hospital, gotri |
| Address |
206-TB Chest OPD,Department of Pulmonary Medicine,GMERS Medical college and hospital,Gotri,Vadodara
206-TB Chest OPD,Department of Pulmonary Medicine,GMERS Medical college and hospital,Gotri,Vadodara
Vadodara
GUJARAT
390021
India |
| Phone |
9879771079 |
| Fax |
|
| Email |
dranandkpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical college and hospital, gotri, vadodara |
|
|
Primary Sponsor
|
| Name |
Khushboo Chahwala |
| Address |
GMERS Medical college and hospital, gotri |
| Type of Sponsor |
Other [Self] |
|
|
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 khushboo chahwala |
Pulmonary medicine opd in GMERS medical college and hospital, gotri |
206-TB Chest OPD in department of pulmonary medicine, in GMERS medical college and hospital, gotri road, gotri
Vadodara
GUJARAT |
9712231496
khushboochahwala66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human 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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
Previously confirmed COVID positive by rapid antigen test or rtpcr swab test.
Completed 1 month after positive test.
Willing to participate and give consent. |
|
| ExclusionCriteria |
| Details |
Patients having malignancy and other chronic conditions.
Patients living with HIV aids. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess characteristics and clinical features in patients recovered from covid-19 patients |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect on quality of life of patients recovered from covid-19 |
7 months |
|
|
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)
|
25/12/2020 |
| 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="7"
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
|
Coronavirus disease 2019 (COVID-19) •contagious respiratory and vascular disease causing severe acute respiratory syndrome. (SARS-CoV-2). •The first case was identified in Wuhan China in December 2019. •Common symptoms of COVID-19 include fever, cough, fatigue, breathing difficulties, and loss of smell and taste. •Symptoms begin one to fourteen days after exposure to the virus. •It is anticipated that COVID-19 may have a major impact on physical, cognitive, mental and social health status, also in patients with mild disease presentation. •In the coming weeks and months, emphasis will gradually involve post-acute care of COVID-19 survivors. • Previous outbreaks of coronaviruses have been associated with persistent pulmonary function impairment, muscle weakness, pain, fatigue, depression, anxiety, vocational problems, and reduced quality of life to various degrees. •The extent to which impacts on health persist after hospital discharge, however, is uncertain. |