| CTRI Number |
CTRI/2020/09/028087 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of severity of chest CT findings in covid 19 patients with pre-existing illness |
|
Scientific Title of Study
|
Evaluation of HRCT chest manifestation in COVID 19 patients with pre-existing comorbidity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Das |
| Designation |
Assistant Professor |
| Affiliation |
KIMS Hospital |
| Address |
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9205569267 |
| Fax |
|
| Email |
swati.das@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Das |
| Designation |
Assistant Professor |
| Affiliation |
KIMS Hospital |
| Address |
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9205569267 |
| Fax |
|
| Email |
swati.das@kims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Swati Das |
| Designation |
Assistant Professor |
| Affiliation |
KIMS Hospital |
| Address |
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Department of Radiology, KIMS Hospital,Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9205569267 |
| Fax |
|
| Email |
swati.das@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Odisha Covid Hospital,KIMS, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
KIMS Hospital |
| Address |
Kalinga Institute of Medical Sciences, KIIT Deemed-to-be University, Bhubaneswar, Odisha, 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 |
| Dr Swati Das |
KIMS Hospital |
Department of Radiology, Kalinga Institute of Medical Sciences, KIIT Deemed-to-be University, Bhubaneswar, Odisha
Khordha
ORISSA |
9205569267
swati.das@kims.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,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 the COVID positive patients admitted to Odisha COVID hospital, KIMS. with positive HRCT chest features. |
|
| ExclusionCriteria |
| Details |
Patients who have not undertaken RT-PCR and HRCT thorax. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the degree of severity of HRCT chest manifestation in COVID patients with pre-existing comorbidity. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the clinical severity with CT severity |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
20/10/2020 |
| 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="4"
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
|
COVID 19
(corona virus disease) is a rapidly spreading, contagious infection caused by
novel corona virus predominantly affecting the respiratory system. It has
become a global pandemic.1 There are various research works being
done presently all over the world for understanding the pathogenesis, clinical,
biochemical, radiological manifestations of the disease, so that proper
management can be achieved. Patients suffering from COVID19 having pre-existing
comorbidities or of elderly age group have shown worse prognosis.2 CT
has high accuracy for the diagnosis of COVID 19 by revealing the features of
viral pneumonia and hence helpful in early diagnosis and proper patient
management and follow up.3 In this study we want to focus on the
HRCT chest findings of COVID 19 patients with pre-existing comorbidities. |