| CTRI Number |
CTRI/2021/08/035758 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Explore the Long-Term Consequences in Covid-19 Recovered Individual. |
|
Scientific Title of Study
|
An Ambidirectional, Descriptive, Follow-Up, Cohort Study to Explore the Long-Term Consequences in Covid-19 Recovered Individual. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RAJESH V |
| Designation |
Professor |
| Affiliation |
Adichunchanagiri University |
| Address |
Clinical Trial Center
2nd floor
Room no 001
AH and RC
BG Nagara
Mandya
Mandya
KARNATAKA
571448
India |
| Phone |
09980038331 |
| Fax |
|
| Email |
rajeshvenky_research@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogendra Shrestha |
| Designation |
Research Scholar |
| Affiliation |
Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University |
| Address |
Clinical Trial Center
2nd floor
Room no 001
AH and RC
BG Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
7348944358 |
| Fax |
|
| Email |
dryogendrastha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogendra Shrestha |
| Designation |
Research Scholar |
| Affiliation |
Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University |
| Address |
Clinical Trial Center
2nd floor
Room no 001
AH and RC
BG Nagara
Mandya
KARNATAKA
571448
India |
| Phone |
7348944358 |
| Fax |
|
| Email |
dryogendrastha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adichunchanagiri University |
|
|
Primary Sponsor
|
| Name |
Adichunchanagiri University |
| Address |
Adichunchanagiri University B G NAGARA |
| 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 |
| Dr Rajesh V |
Adichunchanagiri Hospital And Research Centre |
Clinical Trial Center
2nd floor
room no 001
AH and RCClinical Trial Center
2nd floor
room no 001
Mandya
KARNATAKA |
09980038331
rajeshvenky_research@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AH and RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Covid-19 recovered |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All the individual of both genders of age ≥18 years.
COVID-19 survivors with a uniform revised discharge policy for Covid-19 according to Ministry of Health and Family Welfare, Government of India.
All the individual who will give a consent.
|
|
| ExclusionCriteria |
| Details |
Any COVID-19 patient who does not have a uniform revised discharge policy for Covid-19 according to Ministry of Health and Family Welfare, Government of India.24
Any COVID-19 survivors with a history of psychiatric illness, tuberculosis and human immunodeficiency virus (HIV) syndrome.
An individual not willing to come for follow-up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study can assess long-term consequences in Covid-19 recovered individuals.
This study helps in early detection and address of health-related problems associated to and Covid-19 recovered individuals.
|
3 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study can assess long-term consequences in Covid-19 recovered individuals.
This study helps in early detection and address of health-related problems associated to and Covid-19 recovered individuals.
The study can evaluate the stigma associated with Covid-19.
The study can help to explore and form a rehabilitation strategy to combat post Covid-19.
This study can assess the negative impacts of Covid-19 in quality of life (QoL).
|
3 years |
|
|
Target Sample Size
|
Total Sample Size="202"
Sample Size from India="202"
Final Enrollment numbers achieved (Total)= "624"
Final Enrollment numbers achieved (India)="624" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/08/2021 |
| Date of Study Completion (India) |
08/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
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
|
Due to a lack of clear definition, the available information about long-term health consequences of post-Covid-19 is still poor and controversial; few studies with small sample sizes and the longest follow-up period of 6 months after release from the hospital have explored into some symptoms that have persisted such as fatigue and dyspnoea, anosmia/dysgeusia, impaired pulmonary function, chest image abnormalities, sleep difficulties, and anxiety or depression. COVID-19 survivors’ future is unknown, and if the virus continues to spread among us for years, long-term consequences may mount massively. Understanding the long-term clinical consequences of Covid-19 infection appears to be critical to in gaining a better understanding of the illness. Covid-19 patients must be monitored after discharge to determine the extent and severity of long-term effects. |