Liver Function Test Abnormalities in COVID-19

Completed

• Conditions: Liver Function Tests Abnormalities
• Interventions: Other: No intervention

• Registration Number: NCT04763395
• Lead Sponsor: Sohag University

Brief Summary

With the increasing number of COVID-19 infected patients, several studies reported that the liver is the most frequently affected organ after lung damage. The percentage of infected patients who had abnormal levels of transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) was about 14.8-53.1%. The elevation in serum bilirubin was mostly mild.

Aims of work:

* To study liver function tests abnormalities in Egyptian patients who infected with COVID19

* To evaluate if liver function test abnormalities are related to the severity of the Covid19.

Detailed Description

This retrospective study will be conducted on 100 patients who were diagnosed as SARS COVID19 positive. The data will be collected from patient records in COVID19 isolation hospitals in Sohag governorate and isolation department in Sohag university hospitals during the period from the start of June 2020 to the end of July 2020.

The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.

Inclusion criteria:

Patients with Covid19 positive PCR.

Exclusion Criteria:

Patients with chronic liver diseases as liver cirrhosis, Hbs Ag positive, or patients having anti-HCV antibodies positive and HCV RNA positive.

The Data will be collected according to the rules of the Sohag university ethical committee. The following will be collected

1. Data about clinical manifestations including fever, cough, dyspnea, fatigue, and diarrhea.

2. Laboratory investigation:

* CBC -Total bilirubin and direct

* AST - ALT

* Albumin - Prothrombin time and concentration

* CRP -D-dimer

* Serum ferritin

3. Assessment of the severity of the disease:

Patients were classified into severe or mild cases based on results from chest radiography, clinical examination, and symptoms.

* Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types.

* A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.

* Severe pneumonia was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR \>-30 times/minute; ii) hypoxia: oxygen saturation (resting state) \<-93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) \<- 300 mmHg (millimeters of Mercury), or iv) the occurrence of respiratory or another organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock

4. Statistical analysis: Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.

Study Timeline

• Study Start: 2021-01-29
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-18
• Primary Completion: 2021-02-20
• Study First Posted: 2021-02-21
• Study Completion: 2021-03-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Patients with Covid19 positive PCR.

Exclusion Criteria

Patients with chronic liver diseases as liver cirrhosis, Hbs Ag positive, or patients having anti-HCV antibodies positive and HCV RNA positive

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-severe COVID19	No intervention	* Patients with mild symptoms (i.e., fever, cough, expectoration, and other upper respiratory tract symptoms), and without abnormalities, or with mild changes on chest radiography, were classified as non-severe types. * A mild change in chest radiography is defined by multiple small patchy shadows and interstitial changes, mainly in the outer zone of the lung and under the pleura.
Severe Covid19	No intervention	Severe COVID19 was defined by the presence of any of the following conditions: i) significantly increased respiration rate (RR): RR \>-30 times/minute; ii) hypoxia: oxygen saturation (resting state) \<-93%; iii) blood gas analysis: partial pressure of oxygen/fraction of inspired oxygen (PaO2) /FiO2) \<- 300 mmHg (millimeters of Mercury), or iv) the occurrence of respiratory or another organ failure that require Intensive care unit (ICU) monitoring and treatment, or shock

Primary Outcome Measures

Name	Time	Method
Percentage of liver function tests abnormalities in Egyptian patients who infected with COVID19 -To evaluate if liver function test abnormalities are related to the severity of the Covid19.	during the period from the start of June 2020 to the end of July 2020
Liver function test abnormalities among patients with severe and non-severe disease	during the period from the start of June 2020 to the end of July 2020
Risk factors of Liver function test abnormalities	during the period from the start of June 2020 to the end of July 2020

Trial Locations

Locations (1)

Mona Mohammed Abdelrhman; 🇪🇬 Sohag, Egypt