| CTRI Number |
CTRI/2021/01/030197 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
CORRELATION OF HRCT CHEST IMAGING FINDINGS WITH DISEASE STATUS IN
COVID-19 PATIENTS |
|
Scientific Title of Study
|
CLINICO-RADIOLOGICAL EVALUATION AND CORRELATION OF
HRCT CHEST IMAGING FINDINGS WITH DISEASE STATUS IN
COVID-19 PATIENTS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreedhar Mohan Menon |
| Designation |
Post Graduate Resident |
| Affiliation |
Kalinga institute of Medical Sciences |
| Address |
Deparment of Radio-Diagnosis, Kalinga Institute of Medical Sciences, KIIT Campus 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
9539593892 |
| Fax |
|
| Email |
dr.sreedharmenon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr COL Kamal Kumar Sen |
| Designation |
HOD and Professor, Department of Radiodiagnosis |
| Affiliation |
Kalinga institute of Medical Sciences |
| Address |
Deparment of Radio-Diagnosis, Kalinga Institute of Medical Sciences, KIIT Campus 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
9539593892 |
| Fax |
|
| Email |
kamal.sen@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sreedhar Mohan Menon |
| Designation |
Post Graduate Resident |
| Affiliation |
Kalinga institute of Medical Sciences |
| Address |
Deparment of Radio-Diagnosis, Kalinga Institute of Medical Sciences, KIIT Campus 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
9539593892 |
| Fax |
|
| Email |
dr.sreedharmenon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Science
KIIT Campus 5, KIIT Raod, Patia, Bhubaneswar, Odhisha 751024 |
|
|
Primary Sponsor
|
| Name |
Kalinga Institute of Medical Science |
| Address |
Kalinga Institute of Medical Science
KIIT Campus 5, KIIT Raod, Patia, Bhubaneswar, Odhisha 751024 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sreedhar Mohan Menon |
Kalinga Institute of Medical Science |
Deparment of Radio-Diagnosis, Kalinga Institute of Medical Sciences, KIIT Campus 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
9539593892
dr.sreedharmenon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES (KIMS) |
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 |
6.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All COVID 19 positive patients who have undergone HRCT Chest on admission and repeat scan. |
|
| ExclusionCriteria |
| Details |
1. Clinically suspected COVID cases who are negative on RT-PCR testing.
2. COVID positive patients, who have not undergone HRCT chest. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To identify the imaging features of COVID19 on HRCT Chest.
2. To correlate the HRCT Chest findings with clinical severity of the disease.
3. To analyse the temporal changes in imaging findings on HRCT Chest over the course of the disease.
|
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyse the temporal changes in imaging findings on HRCT Chest over the course of the disease. |
6 WEEKS |
|
|
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)
|
10/01/2021 |
| 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="2"
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
|
HRCT changes in chest image are seen earlier than clinical symptoms and the high resolving power of CT helps in detecting smaller lesions in cases of COVID-19. Early diagnosis of COVID-19 will enable patients to be isolated and treated in time, so that the progression of the disease can be avoided, resulting in good prognosis and reduced mortality. Analysis of the HRCT Chest images will be done on the basis of available classification and criteria The CT severity index will be calculated by two skilled radiologists and correlated with clinical severity. Changes in HRCT CHEST findings will be observed in the follow up scans.
The total CT score is the sum of the individual lobar scores and can range from 0 (no involvement) to 25 (maximum involvement), when all the five lobes show more than 75% involvement. |