| CTRI Number |
CTRI/2020/09/028069 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
23/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Variation in biochemical parameters in COVID-19 infection |
|
Scientific Title of Study
|
Role of biochemical markers in COVID-19 infection |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Sowmya |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of Higher Education & Research, SRIHER(DU) |
| Address |
Department of biochemistry
Sri Ramachandra Laboratory services Biochemistry, C- BI
No: 1 Ramachandra Nagar Porur Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
ksowmya@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Sowmya |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra institute of Higher Education & Research, SRIHER(DU) |
| Address |
Department of biochemistry
Sri Ramachnadra Laboratory Services Biochemistry, C- BI
No: 1 Ramachandra Nagar Porur Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
|
| Fax |
|
| Email |
ksowmya@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
S Sowmiya |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra institute of Higher Education & Research, SRIHER(DU) |
| Address |
Department of Biochemistry
SRIHER
No: 1 Ramachandra Nagar Porur Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9514621388 |
| Fax |
|
| Email |
sowmiyabpt17@gmail.com |
|
|
Source of Monetary or Material Support
|
| S Sowmiya (self)
Department of Biochemistry
SRIHER,No: 1 Ramachandra Nagar Porur Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education Research Institute SRIHERDU |
| Address |
No 1 Ramachandra Nagar Porur Chennai 600116 |
| 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 K sowmya |
Sri Ramachandra Medical College and Research Institute, SRIHER(DU) |
Sri Ramachandra Laboratory Services Biochemistry, C-BI
SRIHER
No 1 Ramachandra Nagar Porur Chennai 600116
Kancheepuram
TAMIL NADU |
9600085116
ksowmya@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SRIHER |
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 |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
o Data of Individuals tested with Positive RT- PCR/ viral nucleic acid test for COVID-19 will be accessed
o Patients Presenting with mild / No symptoms (Isolation ward participants data will be accessed)
o Patients Presenting with moderate/ severe symptoms of COVID – 19 (ICU participants data will be accessed)
|
|
| ExclusionCriteria |
| Details |
Following Records of investigations will not be accessed:
o Data of Individuals with Liver disease, Rheumatoid arthritis, Renal disease & cardiac disease will not be accessed.
o Reports presenting with any other bacterial infections will not be accessed
o Reports of Pregnant women and age below <18 year’s will not be considered.
o Data of Patients presenting with dengue, malaria infections will not be acquired.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the biochemical alterations and prognosis of the COVID – 19 pandemic infection |
6 - 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Elevated LDH values were associated with 6- fold increased odds of severe COVID-19 infection. Hyper ferritinemia directly contributes to immune-suppressive and pro-inflammatory effects, and contributing to the cytokine storm and increased severity of the disease. Higher levels of hs-CRP can be a predictive marker in determining inflammatory response in COVID – 19. |
6 - 7 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/10/2020 |
| 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
|
-- NIL -- |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this pandemic crisis, laboratory biomarkers play
a vital role in screening and in monitoring the prognosis of the disease. By evaluating the levels of the enzyme markers
& inflammatory markers levels in COVID – 19 patient helps us to understand
the biochemical alterations and prognosis of the COVID – 19 pandemic infection. |