| CTRI Number |
CTRI/2020/12/029970 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of COVID 19 features in HRCT Chest of patients who have no evidence of Tuberculosis infection and comparison between COVID and Tuberculosis imaging features in COVID patients. |
|
Scientific Title of Study
|
Analysis of COVID 19 with HRCT Chest in IGRA negative patients- A study in a COVID Hospital of Odisha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhansu Sekhar Mohanty |
| Designation |
Assistant professor |
| Affiliation |
Kalinga institute of medical science |
| Address |
Department of Radiodiagnosis, kalinga institute of Medical Sciences, Patia, Bhubaneswar
Department of Radiodiagnosis, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9994663960 |
| Fax |
|
| Email |
sudhansumohanty2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhansu Sekhar Mohanty |
| Designation |
Assistant professor |
| Affiliation |
Kalinga institute of medical sciences |
| Address |
Department of Radiodiagnosis, kalinga Institute of Medical Sciences, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9994663960 |
| Fax |
|
| Email |
sudhansumohanty2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhansu Sekhar Mohanty |
| Designation |
Assistant professor |
| Affiliation |
Kalinga institute of medical science |
| Address |
Department of Radiodiagnosis, kalinga institute of Medical Sciences, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9994663960 |
| Fax |
|
| Email |
sudhansumohanty2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis, Kalinga Institute of Medical Sciences, Patia, Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
KIMS Hospital |
| Address |
Patia, Bhubaneswar |
| 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 Sudhansu Sekhar Mohanty |
Department of Radiology, KIMS COVID Hospital |
Patia, Bhubaneswar
Khordha
ORISSA |
9994663960
sudhansumohanty2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
1.COVID 19 positive patients with imaging features suggestive of exposure to M. Tuberculosis.
2.Those COVID positive patients who have undergone both HRCT and IGRA.
|
|
| ExclusionCriteria |
| Details |
COVID 19 negative patients
Absence of any evidence of TB on imaging
Those who have not undergone IGRA
Those who have refused IV contrast study when indicated. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The cases were evaluated by a panel of skilled radiologists for identifying the imaging characteristics to develop a generalised protocol to differentiate COVID-19 from TB in Indian population |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of TB as co-morbidity with COVID in the study population. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/01/2021 |
| 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="0"
Months="6"
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 outbreak of
COVID-19 started in December 2019, in Wuhan, China.China has accumulated huge clinical
experience and reported about epidemiological, clinical, laboratory, and
imaging features. In India,at
the time of writing there are around 1.4 lakhs confirmed cases of COVID-19 out
of which approximately 3800 are dead. As
far as Tuberculosis is concerned, World health organisation (WHO)
statistics for 2011 giving an estimated incidence figure of 2.2 million cases
of TB for India out of a global incidence of 9.6 million cases. In India each year, approximately
220,000 deaths are reported due to Tuberculosis. This public
health problem
is the world’s largest Tuberculosis epidemic. Keeping in mind the effects
of Tuberculosis in India and its imaging wise similarities with COVID-19, it is
necessary to develop some imaging protocols which can differentiate TB from
COVID-19 on HRCT thorax . This paper attempts to indicate the imaging findings
in COVID patients associated with Tuberculosis and hence to differentiate the
both similarly looking entity on HRCT thus leading to effective management
accordingly. |