| CTRI Number |
CTRI/2020/08/026981 [Registered on: 04/08/2020] Trial Registered Prospectively |
| Last Modified On: |
04/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of changes in levels of certain blood parameters in covid-19 patients |
|
Scientific Title of Study
|
Analysis of biochemical marker changes in covid-19 patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrUtsav Parmar |
| Designation |
Tutor |
| Affiliation |
GCS Hospital College and Research center |
| Address |
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Ahmadabad
GUJARAT
382421
India |
| Phone |
8000431030 |
| Fax |
|
| Email |
utsav1712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrUtsav Parmar |
| Designation |
Tutor |
| Affiliation |
GCS Hospital College and Research center |
| Address |
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Ahmadabad
GUJARAT
382421
India |
| Phone |
8000431030 |
| Fax |
|
| Email |
utsav1712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrUtsav Parmar |
| Designation |
Tutor |
| Affiliation |
GCS Hospital College and Research center |
| Address |
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Ahmadabad
GUJARAT
382421
India |
| Phone |
8000431030 |
| Fax |
|
| Email |
utsav1712@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Hospital College and Research center |
|
|
Primary Sponsor
|
| Name |
GCS Hospital College and Research center |
| Address |
GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India |
| 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 Utsav Parmar |
GCS Hospital College and Research center |
Department of Biochemistry GCS Hospital college and research center Opposite DRM Office Near Chamunda Bridge Naroda Road Ahmedabad 380 025 Gujarat India
Ahmadabad
GUJARAT |
8000431030
utsav1712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Biocmedical and Health Research)GCS Medical College Hospital and Research Center |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male and female of any age will be selected who are admitted at GCS Hospital with RT-PCR positive Covid 19. |
|
| ExclusionCriteria |
| Details |
Known case of Renal failure
Known case of congestive cardiac failure
Acute MI
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishment of correlation with levels of biochemical markers to the diesease progression,outcome of the disease and need for intensive care etc. |
At discharge or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| designing algorithm for point of intervention and type of intevention based on levels of biochemical markers |
at discharge or death |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
14/08/2020 |
| 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="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
|
As the number of COVID-19 patients is dramatically increasing worldwide and treatment in intensive care units (ICU) has become a major challenge, early recognition of severe forms of COVID-19 is absolutely essential for timely triaging of patients.We review different biomarkers to evaluate if they are able to predict clinical outcomes and correlate with the severity of COVID-19 disease.1000 patients will be selected of covid 19 ,diagnosed by RT-PCR admitted at GCS hospital,ahmedabad. Levels of various biochemical markers of the selected patients will be analyzed.The study aims to design an algorithm for prediction of disease progression, hospital stay ,need for intensive care etc based on changes in levels of biochemical markers.It also aims to help in understanding disease process better and may provide clue for management. |