Skip to main content
OpenTrials
Completed

NCT Number: NCT04763395

Liver Function Test Abnormalities in COVID-19

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

  • Data about clinical manifestations including fever, cough, dyspnea, fatigue, and diarrhea.
  • Laboratory investigation:
  • CBC -Total bilirubin and direct
  • AST - ALT
  • Albumin - Prothrombin time and concentration
  • CRP -D-dimer
  • Serum ferritin
  • 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
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

    Time frame: during the period from the start of June 2020 to the end of July 2020

  2. Risk factors of Liver function test abnormalities

    Time frame: during the period from the start of June 2020 to the end of July 2020

  3. Liver function test abnormalities among patients with severe and non-severe disease

    Time frame: during the period from the start of June 2020 to the end of July 2020

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Liver Function Test Abnormalities in COVID-19 Egyptian Patients

Acronym: COVID-19

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.