| CTRI Number |
CTRI/2021/04/033047 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of markers like D-Dimer and Coagulation parameters in predicting outcome in COVID-19 patients |
|
Scientific Title of Study
|
Prognostic role of D-Dimer and Coagulation parameters in 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 |
Kowshik V |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8220281380 |
| Fax |
|
| Email |
vkowshik94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Emmanuel Bhaskar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9840717971 |
| Fax |
|
| Email |
drebhaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kowshik V |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
8220281380 |
| Fax |
|
| Email |
vkowshik94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai - 600116 |
|
|
Primary Sponsor
|
| Name |
Kowshik V |
| Address |
Post graduate, Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116 |
| Type of Sponsor |
Other [[Principal Investigator]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Emmanuel Bhaskar |
Professor, Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kowshik V |
Sri Ramachandra Institute of Higher Education and Research |
Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
8220281380
vkowshik94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
RT-PCR of nasopharyngeal or oropharyngeal swab confirmed COVID-19 patients more than or equal to 18 years of age and either gender hospitalized for the illness |
|
| ExclusionCriteria |
| Details |
COVID-19 positive patients less than 18 years of age
Patients on pre-hospitalization anti-coagulation
Patients with cancer and prior thrombocytopenia or coagulopathy
Patients having hospital stay less than 3 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical recovery of the patient |
At baseline at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications during the hospital stay and immediately after discharge |
At baseline at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
03/05/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is prospective and will take place in the Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur ,Chennai between March 2021 and March 2023 after obtaining ethical clearance. It aims to evaluate the prognostic role of D-Dimer with illness severity. We also aim to observe the coagulation parameters (PT, PTT and INR) in patients with elevated D-Dimer and assess its correlation with complications and outcome. The identification of effective laboratory biomarkers capable of triaging patients with COVID-19 infection is very necessary taking into account the unpredictable course of the disease. Studies have shown a significant relation between D-Dimer levels and disease progression. Using the pre-structured proforma, patient’s clinical and laboratory data are collected and analysed after getting their consent. D-dimer values, course in hospital - oxygen requirement , drugs used with dosage, complications or adverse events that have occurred will all be recorded and statistical analysis will be done to correlate the two. The results of our study will help prompt triaging of the high risk patients and help rethink our treatment approach. |