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Liver Function Test Abnormalities in COVID-19 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04763395
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Mona Mohammed Abdelrhman, Sohag University

Tracking Information
First Submitted Date February 17, 2021
First Posted Date February 21, 2021
Last Update Posted Date February 21, 2021
Actual Study Start Date January 29, 2021
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2021)
  • 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 ]
  • Risk factors of Liver function test abnormalities [ Time Frame: 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 [ Time Frame: during the period from the start of June 2020 to the end of July 2020 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Liver Function Test Abnormalities in COVID-19
Official Title Liver Function Test Abnormalities in COVID-19 Egyptian Patients
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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
Condition Liver Function Tests Abnormalities
Intervention Other: No intervention
No intervention
Study Groups/Cohorts
  • 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.
    Intervention: Other: 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
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 18, 2021)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2021
Estimated Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Mona Mohammed, Lecturer 01021025895 ext 02 monamohamed@med.sohag.edu.eg
Contact: Noha Shafik, lecturer 010067261504 ext 02 Nohasaber@med.sohag.edu.eg
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04763395
Other Study ID Numbers Soh-Med-21-02-27
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Mona Mohammed Abdelrhman, Sohag University
Study Sponsor Sohag University
Collaborators Not Provided
Investigators
Study Chair: Asmaa Mahmoud, lecturer Sohag University
Study Chair: Mustafa Younis, lecturer Sohag University
Study Chair: Mahmoud Mahmoud, lecturer Sohag University
PRS Account Sohag University
Verification Date February 2021