CTRI Number |
CTRI/2022/10/046480 [Registered on: 14/10/2022] Trial Registered Prospectively |
Last Modified On: |
13/10/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Correlation of inflammatory markers with oxygen saturation and disease severity in hospitalized COVID-19 patients |
Scientific Title of Study
|
Correlation of inflammatory markers with oxygen saturation and disease severity 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 |
Nayana Devang |
Designation |
Assistant Professor of Biochemistry, Kanachur Institute of Medical Sciences |
Affiliation |
Department of Biochemistry Kanachur Institute of Medical Sciences |
Address |
Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Natekal. Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Nateka. Dakshina Kannada KARNATAKA 575018 India |
Phone |
08050120959 |
Fax |
|
Email |
devangnayana@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Nayana Devang |
Designation |
Assistant Professor |
Affiliation |
Department of Biochemistry Kanachur Institute of Medical Sciences |
Address |
Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Natekal. Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Natekal. Dakshina Kannada KARNATAKA 575018 India |
Phone |
08050120959 |
Fax |
|
Email |
devangnayana@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Nayana Devang |
Designation |
Assistant Professor |
Affiliation |
Department of Biochemistry Kanachur Institute of Medical Sciences |
Address |
Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Natekal. Department of Biochemistry
Kanachur Institute of Medical Sciences, Mangalore University Road, Natekal. Dakshina Kannada KARNATAKA 575018 India |
Phone |
08050120959 |
Fax |
|
Email |
devangnayana@gmail.com |
|
Source of Monetary or Material Support
|
Kanachur Institute of Medical Sciences |
|
Primary Sponsor
|
Name |
Kanachur Institute of Medical Sciences |
Address |
Mangalore University Road, Natekal |
Type of Sponsor |
Private medical college |
|
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 Nayana D |
Tertiary care hospital, Kanachur Institute of Medical Sciences |
Mangalore University Road, Natekal Dakshina Kannada KARNATAKA |
08050120959
devangnayana@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kanachur 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, (2) ICD-10 Condition: J129||Viral pneumonia, unspecified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Covid-19 patients admitted to tertiary care hospital aged 18-70 years. |
|
ExclusionCriteria |
Details |
Patients with cancer, pre-existing musculoskeletal disease and chronic diseases of liver, kidney and heart, bacterial and non-covid viral infections, those on immunosuppressive drugs for another disease, pregnant and lactating women. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Survivors or non-survivors |
Four weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
CRP, LDH or ferritin predicts COVID-19 mortality and severity.
CRP, LDH or ferritin show negative correlation with oxygen saturation and positive correlation with markers of liver function and kidney function. |
Four weeks |
|
Target Sample Size
|
Total Sample Size="190" Sample Size from India="190"
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)
|
19/10/2022 |
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="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Study design: Cross-sectional study. Study participants: Patients with covid-19 infection confirmed by RT-PCR, aged between 18- 70 years will be included. This cross-sectional study will include covid-19 patients from inpatient and outpatient department of Kanachur Institute of Medical Sciences. Details of demographic parameters such as age and gender; comorbidities including diabetes, hypertension, cardiovascular, respiratory and other diseases; details of covid symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell, breathlessness, occurance of respiratory failure, multiple organ failure will be collected from electronic medical records. Covid-19 disease severity will be classified to severe and nonsevere according to the classification guidelines put forth by Government of Karnataka. Covid patients who are asymptomatic and with mild to moderate illness with SpO2 90% to ≤93% on room air and respiratory rate ≥24/min will be the nonsevere group. Covid patients with severe and critical illness with SpO2 <90% on room air at sea level and respiratory rate > 30/min will be included in the severe group. Serum level of C-reactive protein (CRP) is determined using autoanalyser Vitros 3600 based on the principle of the latex agglutination. Serum level of lactate dehydrogenase (LDH) is determined using autoanalyser Vitros 3600 based on the principle of the enzymatic coupling reaction. LDH catalyzes the conversion of pyruvate and NADH to lactate and NAD+ . Oxidation of NADH will be monitored by reflectance spectrophotometry, which is used to measure the LDH activity. The oxygen saturation (SpO2) in the blood is analyzed using pulse oxymeter. Statistical analysis will be done using SPSS version 20. Values will be expressed as mean ± standard deviation or median ± interquartile range. Independent sample t-test will be used to determine significant differences in the CRP and LDH levels between severe and nonsevere covid patients. Correlation of inflammatory markers with disease mortality and SpO2 will be done by Karl Pearson’s or Spearman correlation. CRP and LDH levels will be compared between severe and nonsevere risk categories using T-test/Mann-Whitney-Wilcoxon test. |