| CTRI Number |
CTRI/2020/10/028525 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of association of chest x ray with clinical severity in hospitalised covid19 patients |
|
Scientific Title of Study
|
Chest x ray findings with clinical severity in hospitalized COVID19 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandakrishna B |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Department of Medicine
Kasturba Medical College
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9914201838 |
| Fax |
|
| Email |
nandaksb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandakrishna B |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Department of Medicine
Kasturba Medical College
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9914201838 |
| Fax |
|
| Email |
nandaksb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandakrishna B |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education |
| Address |
Department of Medicine
Kasturba Medical College
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9914201838 |
| Fax |
|
| Email |
nandaksb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nandakrishna B |
| Address |
Department of Medicine
Kasturba Medical College
Manipal Academy of Higher Education, Udupi |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Nandakrishna B |
Kasturba Hospital, Manipal |
Manipal Academy of Higher Education,
Manipal
Udupi
KARNATAKA |
9914201838
nandaksb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional ethics Committe |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults, age> 18 hospitalized with Covid 19 |
|
| ExclusionCriteria |
| Details |
Pregnant females
Subjects already treated with steroids and anticoagulation prior to hospitalizatiNot consenting to the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chest x ray findings will be classified as mild, moderate and severe and will be compared with clinical severity of ARDS in covid 19 patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the serum lactate dehydrogenase and ferritin values with chest x ray severity |
baseline |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
31/10/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study to compare the findings on chest x ray of the patients admitted with covid 19 with clinical severity of acute respiratory distress syndrome and hypoxia. chest x ray findings will be categorised as mild, moderate and severe on admission and compared with degrees of hypoxia. this study will explore the utility of chest x ray in covid 19 patients |