| CTRI Number |
CTRI/2021/06/034352 [Registered on: 23/06/2021] Trial Registered Prospectively |
| Last Modified On: |
21/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Study of investigation tools in COVID 19 patients anx how it affects on patients outcome |
|
Scientific Title of Study
|
Study of correlation of biomarkers in COVID 19 patients with patients outcome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naman Dharmeshbhai Patel |
| Designation |
Resident Doctor, Department of TB & Chest, GCSMCHRC, Ahmedabad |
| Affiliation |
GCS medical college and research centre |
| Address |
A/802 suryoday tower near sattadhar char rasta
Ahmadabad
GUJARAT
380061
India |
| Phone |
7575020539 |
| Fax |
|
| Email |
npatel5887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rushi rameshbhai Patel |
| Designation |
Consultant, Department of TB & Chest, GCSMCHRC, Ahmedabad |
| Affiliation |
Gcs medical college, hospital and research centre |
| Address |
G2,210 gcs hospital, near chamunda bridge, naroda
Ahmadabad
GUJARAT
380025
India |
| Phone |
9825029273 |
| Fax |
|
| Email |
rrpatel9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naman Dharmeshbhai Patel |
| Designation |
Resident Doctor, Department of TB & Chest, GCSMCHRC, Ahmedabad |
| Affiliation |
GCS medical college and research centre |
| Address |
A/802 suryoday tower near sattadhar char rasta
Ahmadabad
GUJARAT
380061
India |
| Phone |
7575020539 |
| Fax |
|
| Email |
npatel5887@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College, Hospital and Research Centre, Opp. DRM Office, naroda Road, Ahmedabad-380025, Gujarat |
|
|
Primary Sponsor
|
| Name |
GCS medical college and hospital centre |
| Address |
GCS medical college and hospital centre, ahmedabad, gujarat |
| 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 |
| naman patel |
Department of TB & Chest, GCS Medical College, hospital and Research Centre |
Opd no. 28, ward 7C.
Ahmadabad
GUJARAT |
7575020539
npatel5887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECGCSMCH&RC |
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 |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all age group, both sexes,including covid 19 rtpcr or hrct positive patients those who give consent for participation |
|
| ExclusionCriteria |
| Details |
including all covid 19 patients those who refuse to give consent and who took dama as their outcomes are not favorable. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation of the diagnostic and prognostic value of the serum biomarkers related to pandemic covid 19and assess the severity of its outcome s in current population |
At the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the mortality rate in covid 19 patients |
At the end of 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/06/2021 |
| 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="5"
Days="30" |
|
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
|
This study is allaboutthe correlation of biomarkers in covid 19 patients with patients outcome. This study aims to explore the different serum biomarkers role including il6, crp, pct, s. Ferritin, s. Ldh. In the disease pathogenesis of covid19 and assess how their levels vary depending on the severityof the disease and how they affect overall outcome of the patient. The objective of the study is to determine mortality rate in covid 19 patients. This is a hospital based longitudinal study and type of the study is observational. |