| CTRI Number |
CTRI/2021/03/032292 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
24/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Other |
|
Public Title of Study
|
Spectrum of CT findings in chest in COVID 19 infection and their progression. |
|
Scientific Title of Study
|
Spectrum of Computed Tomography findings in chest in COVID-2019 infection and their temporal evolution. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PARTH PATEL |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Max superspeciality hospital |
| Address |
Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017
Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017
South
DELHI
110017
India |
| Phone |
8669457675 |
| Fax |
|
| Email |
drparthvpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr amit sahu |
| Designation |
Consultant |
| Affiliation |
Max superspeciality hospital |
| Address |
Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017
South
DELHI
110017
India |
| Phone |
8669457675 |
| Fax |
|
| Email |
drsahuamit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandamoyee Dhar |
| Designation |
Senior consultant |
| Affiliation |
MAX SUPERSPECIALITY HOSPITAL |
| Address |
Department of radiodiagnosis,ground floor,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017
South
DELHI
110017
India |
| Phone |
9810418279 |
| Fax |
|
| Email |
anandamoyee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017 |
|
|
Primary Sponsor
|
| Name |
Max Superspeciality Hospital |
| Address |
Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017 |
| 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 PARTH PATEL |
MAX SUPERSPECIALITY HOSPITAL, SAKET COMPLEX |
Department of radiodiagnosis,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017
South
DELHI |
8669457675
drparthvpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAX HEALTHCARE 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 |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients positive for COVID 19 pneumonia Rapid antigen test and / or RT-PCR test. |
|
| ExclusionCriteria |
| Details |
Patients negative for COVID 19 pneumonia Rapid antigen test and / or RT-PCR test.
Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the spectrum of CT findings in COVID 19 pneumonia on different variables.
|
Over the period of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the disease course on CT findings . |
Over the period of 1 year. |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
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)
|
26/03/2021 |
| 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="1"
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
|
Primary purpose of the study is to determine the spectrum of imaging findings in chest on Computed tomography in patients positive for novel COVOD-19 pneumonia infection on rapid antigen test or / and RT-PCR report. furthermore, this study also aims to evaluate the seqential course of disease on basis of imaging findings on chest CT scans. |