Liver Function Test Abnormalities in COVID-19

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04763395
Collaborator
(none)
118
1
1
115.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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

  1. 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

  1. 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 Design

Study Type:
Observational
Actual Enrollment :
118 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Liver Function Test Abnormalities in COVID-19 Egyptian Patients
Actual Study Start Date :
Jan 29, 2021
Actual Primary Completion Date :
Feb 20, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
non-severe COVID19

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.

Other: No intervention
No intervention

Severe Covid19

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

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  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. [during the period from the start of June 2020 to the end of July 2020]

  2. Risk factors of Liver function test abnormalities [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 [during the period from the start of June 2020 to the end of July 2020]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mona Mohammed Abdelrhman Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Chair: Asmaa Mahmoud, lecturer, Sohag University
  • Study Chair: Mustafa Younis, lecturer, Sohag University
  • Study Chair: Mahmoud Mahmoud, lecturer, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mona Mohammed Abdelrhman, Principal investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT04763395
Other Study ID Numbers:
  • Soh-Med-21-02-27
First Posted:
Feb 21, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mona Mohammed Abdelrhman, Principal investigator, Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021