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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.
 
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