| CTRI Number |
CTRI/2020/08/027189 [Registered on: 17/08/2020] Trial Registered Prospectively |
| Last Modified On: |
15/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of chest CT scan in covid19 patients: A study in a dedicated covid hospital of odisha |
|
Scientific Title of Study
|
Evaluation of hrct chest in covid19 patients: A study in a dedicated covid hospital of Odisha |
| Trial Acronym |
HRCT chest in covid19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangram Panda |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga institute of medical sciences (kims) |
| Address |
Department of radiodiagnosis
KIMS hospital
KIIT university campus
Patia
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9090790794 |
| Fax |
|
| Email |
sangram.aju@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangram Panda |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga institute of medical sciences (kims) |
| Address |
Department of Radiodiagnosis
KIMS hospital
KIIT university campus
Patia
Bhubaneswar
Ganjam
ORISSA
751024
India |
| Phone |
9090790794 |
| Fax |
|
| Email |
sangram.aju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangram Panda |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga institute of medical sciences (kims) |
| Address |
Department of Radiodiagnosis
KIMS hospital
KIIT university campus
Patia
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9090790794 |
| Fax |
|
| Email |
sangram.aju@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of radiodiagnosis |
| Address |
KIMS hospital
KIIT university
Bhubaneswar |
| 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 |
| Sangram Panda |
Odisha covid hospital |
KIMS hospital
Patia
Bhubaneswar
Khordha
ORISSA |
9090790794
sangram.aju@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, 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
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All COVID19 positive patients who were admitted in KIMS COVID hospital and had undergone HRCT chest. |
|
| ExclusionCriteria |
| Details |
Clinically suspected COVID cases who were negative on RT-PCR testing.
COVID positive patients, who had not undergone HRCT chest.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe and analyse the imaging characteristics of covid19 pneumonia in hrct chest.
To study the changes in hrct findings of covid19 pneumonia during the course of disease.
|
3 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a grading system basing on the severity of hrct chest findings by correlating with the clinical severity of the disease. |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="1600"
Sample Size from India="1600"
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)
|
20/08/2020 |
| 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="3"
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
|
The purpose of our study is to characterize &
analyse the HRCT chest features in 1600 laboratory-confirmed COVID patients and
correlate the severity of HRCT findings
with their clinical severity. The study also aimed to explore the changes in
HRCT chest findings with duration of disease. |