| CTRI Number |
CTRI/2021/01/030734 [Registered on: 25/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Lung Problems in Covid Recovered Patients |
|
Scientific Title of Study
|
Assessment of Pulmonary Complications in Post Covid Patients |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine
Kalinga Institute of Medical Science, Bhubaneswar
Beleswar
Nayabazar
Cuttack
753004
Khordha
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
debasis.behera3@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine
Kalinga Institute of Medical Science,Bhubaneswar
Beleswar
Nayabazar
Cuttack
753004
Khordha
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
debasis.behera3@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Behera |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute of Medical Science, Bhubaneswar |
| Address |
Department of Pulmonary Medicine
Kalinga Institute of Medical Science,Bhubaneswar
Beleswar
Nayabazar
Cuttack
753004
Khordha
ORISSA
751024
India |
| Phone |
09971852101 |
| Fax |
|
| Email |
debasis.behera3@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| KIMS HOSPITAL
BHUBANESWAR |
|
|
Primary Sponsor
|
| Name |
KIMS HOSPITAL |
| Address |
BHUBANESWAR
ODISHA |
| 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 Debasis Behera |
Kalinga Institute of Medical Science, Bhubaneswar |
Department of Pulmonary Medicine, Out Patient Department, Room No.8
Khordha
ORISSA |
09971852101
debasis.behera3@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kalinga Institute of Medical Science, Bhubaneswar |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
COVID 19 patients 3 months (10-12 weeks) after their hospital discharge
Age> 18yrs
Written informed consent available |
|
| ExclusionCriteria |
| Details |
Patients with previous history of asthma/COPD/ILD
Patients with features of active respiratory tract infection
Conditions which are contraindications to spirometry
Pregnant women
Musculoskeletal disorders that interfere with walking
Presence of previous cardiovascular disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess Residual CT Thorax findings, pulmonary function test and
exercise capacity of recovered covid 19 patients.
To find the corelation between residual changes with that of the
severity of the disease and various laboratory parameters. |
3-12 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the corelation between residual changes with that of the
severity of the disease and various laboratory parameters. |
3-12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2021 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Most of the recovered COVID-19 patients have residual changes in radiology and lung function tests as well. Data regarding the same are not so robust. there is a lack of knowledge regarding the parameters that decide the seriousness of the disease.So we shall take recovered COVID-19 patients after 3 months of their discharge to assess their radiology, lung function tests and exercise capacity. Those patients will residual changes at 3 months will be followed up to 1 year. We will also corelate the residual changes with that of the baseline parameters for any significance. |