| CTRI Number |
CTRI/2020/08/027079 [Registered on: 10/08/2020] Trial Registered Prospectively |
| Last Modified On: |
10/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of lab investigations among hospitalized COVID-19 patients |
|
Scientific Title of Study
|
Biomarkers in prognostic assessment of hospitalized 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 |
Dr Swathy Moorthy |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, TamilNadu
Chennai
TAMIL NADU
600116
India |
| Phone |
9444016401 |
| Fax |
|
| Email |
drswathymoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swathy Moorthy |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, TamilNadu
TAMIL NADU
600116
India |
| Phone |
9444016401 |
| Fax |
|
| Email |
drswathymoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swathy Moorthy |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra University |
| Address |
Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, TamilNadu
TAMIL NADU
600116
India |
| Phone |
9444016401 |
| Fax |
|
| Email |
drswathymoorthy@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education of Research |
|
|
Primary Sponsor
|
| Name |
Dr Swathy Moorthy |
| Address |
Associate Professor, Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, TamilNadu, India |
| 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 |
| DrSPThiagarajan |
SriRamachandra Institute of Higher Education and Research |
SRIHER, Porur, Chennai, TamilNadu
Chennai
TAMIL NADU |
04445982665
deanresearch@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, 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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
all hospitalized COVID-19 patients |
|
| ExclusionCriteria |
| Details |
all hospitalized non COVID-19 patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| positive correlation between biomarkers and prognosis, severity of COVID-19 hospitalized patients |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to see if De Ritis ratio could serve as a prognostic marker for COVID-19 patients |
correlation assessed once data is collected |
|
|
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)
|
17/08/2020 |
| 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="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
|
Corona virus disease 2019 is a rapidly spreading viral infection which is now producing a pandemic outbreak affecting all age groups. we have a spectrum of illness varying from mild to severe illness. the clinical and laboratory results of different age groups are different due to the general susceptibility of the disease and presence of associated co-morbid conditions and life style modifications. the laboratory and radiological findings play an important role in the early diagnosis and treatment of monitoring of COVID-19.Real time reverse transcription PCR assays remain the molecular test of choicefor the etiological diagnosis of SARS CoV2. Transaminases the ALT, AST are altered in viral infections. De Ritis ratio (AST/ALT ratio) is more than 1 in cirrhotics and prognosis was related to the level of the ratio. studies revealed that ratio of less than 1 indicated moderate to severe liver damage. Similarly high LDH levels correlated strongly with severe covid pneumonia as per published data. increased creatinine and blood urea levels, elevated D-dimer, decreased total protein and albumin, increased inflammatory markers like CRP, IL-6, Ferritin are also established. We are attempting to see any positive correlations existing between these laboratory parameters whose combination could be a strong predictor for the severity and prognosis of the COVID-9 disease, especially in a resource limited setting. |