Correlation of inflammatory markers with oxygen saturation and disease severity in hospitalized COVID-19 patients

Not yet recruiting

• Conditions: Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: J129||Viral pneumonia, unspecified,

• Registration Number: CTRI/2022/10/046480
• Lead Sponsor: Kanachur Institute of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-13
• Study Start: 2022-10-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Covid-19 patients admitted to tertiary care hospital aged 18-70 years.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survivors or non-survivors	Four weeks

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tertiary care hospital, Kanachur Institute of Medical Sciences; 🇮🇳 Kannada, KARNATAKA, India

Tertiary care hospital, Kanachur Institute of Medical Sciences

🇮🇳Kannada, KARNATAKA, India

Dr Nayana D

Principal investigator

08050120959

devangnayana@gmail.com