| CTRI Number |
CTRI/2020/12/030070 [Registered on: 28/12/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Inflammatory markers and other biochemical parameters in COVID -19 and their association with mortality outcome in Diabetes verses Non Diabetes patients of coastal karnataka tertiary care hospital. |
|
Scientific Title of Study
|
A Comparative study of Inflammatory markers and biochemical parameters among Diabetic and Non Diabetic patients with COVID – 19 and their influence on the disease outcome in tertiary care hospital of coastal Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaheen B Shaikh |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Biochemistry Yenepoya Medical college University Road Deralakatte Mangalore 575018 karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9663165942 |
| Fax |
|
| Email |
drshaheenshaikh@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaheen B Shaikh |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Biochemistry Yenepoya Medical college University Road Deralakatte Mangalore 575018 karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9663165942 |
| Fax |
|
| Email |
drshaheenshaikh@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaheen B Shaikh |
| Designation |
Associate Professor |
| Affiliation |
Yenepoya Medical College |
| Address |
Department of Biochemistry Yenepoya Medical college University Road Deralakatte Mangalore 575018 karnataka India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9663165942 |
| Fax |
|
| Email |
drshaheenshaikh@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Self, Yenepoya Medical College hospital University Road Deralakatte Mangalore 575018 Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Shaheen B shaikh |
| Address |
Dept of Biochemistry YMC University Road Deralakatte Mangalore Karnataka 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 |
| Dr Shaheen B shaikh |
Yenepoya Medical College Hospital |
Department of Biochemistry
Hospital University Road Deralakatte Mangalore
Dakshina Kannada
KARNATAKA |
9663165942
drshaheenshaikh@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya University Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All the Covid 19 diagnosed (18 -70 years ) and admitted patients at yenepoya Medical college hospital. All patients were diagnosed based on the WHO recommendations for cases who have a positive RT - PCR test for SARS-CoV-2. The diabetic group included all patients with Diabetes on insulin and/or oral hypoglycemic agents . The non-diabetic group included all the other patients with no history of taking antidiabetic medication and who had normal random blood glucose and HbA1c on admission
|
|
| ExclusionCriteria |
| Details |
Patients who had no laboratory investigations will be excluded pregnant females were excluded from the study
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluate and compare the Inflammatory markers in Diabetic and Non Diabetic patients with COVID – 19 in tertiary hospital of coastal Karnataka. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the Inflammatory markers in Diabetic and Non Diabetic patients with COVID – 19 in tertiary hospital of coastal Karnataka. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
01/02/2021 |
| 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="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
|
The pandemic coronavirus disease 2019 (COVID-19) has threaten the global health. The characteristics of inflammatory markers of coronavirus are of great significance for clinical diagnosis and treatment. Diabetes mellitus (DM) is challenging in the context of the COVID-19 pandemic. Diabetes is among the most frequently reported comorbidities in patients infected with COVID-19 .1 We found indicators that may most effectively predict a non-severe COVID-19 patient develop into a severe patient Serum inflammatory markers are acute-phase-protein exhibiting elevated serum concentrations in various inflammatory diseases.2 Here we focus on the Comparing of serum markers for diagnostic and clinical management of patients with COVID-19 in comparison with diabetic and non diabetic patients. Objectives: 1. To evaluate and compare the Inflammatory markers in Diabetic and Non Diabetic patients with COVID – 19 in tertiary hospital of coastal Karnataka. 2. To Study the association of inflammatory markers to outcomes including duration of hospitalization, duration of ICU stay, duration of mechanical ventilation and mortality between Diabetic and Non Diabetic patients with COVID – 19 in tertiary hospital of coastal Karnataka. Hypothesis: COVID – 19 patients with Diabetic mellitus have raised Inflammatory markers and poor prognosis compared to non diabetes COVID – 19 patients . Study design: A Cross sectional study was conducted on COVID 19 positive adult patients (18 -70 years ) from April 1 st 2020 to December 31st 2020. Ethical clearance: The study will be conducted after obtaining the approval from the institutional ethical committee. Inclusion criteria: All the Covid 19 diagnosed (18 -70 years ) and admitted patients at yenepoya Medical college hospital. All patients were diagnosed based on the WHO recommendations for cases who have a positive RT - PCR test for SARS-CoV-2. The diabetic group included all patients with Diabetes on insulin and/or oral hypoglycemic agents . The non-diabetic group included all the other patients with no history of taking antidiabetic medication and who had normal random blood glucose and HbA1c on admission. Exclusion criteria: Patients who had no laboratory investigations will be excluded pregnant females were excluded from the study Clinical data collection: Data is collected after getting the approval from institutional ethical committee . Blood sugar and Hemoglobin A1c (HbA1c), Urea , Creatinine , Ferritin , LDH , CRP , ESR , Procalcitonin ,D Dimer , CBC ,LFT , Electrolyte concentrations and interleukin-6 (IL-6) on admission are taken , Length of stay ,Mehanical Ventilator and 30 days mortality were taken Study period : 9 months (April 1 st 2020 to December 31st 2020). |