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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

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
Liver Function Tests Abnormalities 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
  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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Liver Function Test Abnormalities in COVID-19 Egyptian Patients
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : February 20, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




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. [ 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763395


Contacts
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Contact: Mona Mohammed, Lecturer 01021025895 ext 02 monamohamed@med.sohag.edu.eg
Contact: Noha Shafik, lecturer 010067261504 ext 02 Nohasaber@med.sohag.edu.eg

Locations
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Egypt
Mona Mohammed Abdelrhman Recruiting
Sohag, Egypt
Contact: Mona Abdelrhman, lecturer    01021025895 ext 02    monamohamed@med.sohag.edu.eg   
Contact: Noha Shafik, lecturer    01067261504 ext 02    Nohasaber@med.sohag.edu.eg   
Sub-Investigator: Asmaa Mahmoud, lecturer         
Sub-Investigator: Mustafa Younis, lecturer         
Sub-Investigator: Mahmoud Mahmoud, lecturer         
Sponsors and Collaborators
Sohag University
Investigators
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Study Chair: Asmaa Mahmoud, lecturer Sohag University
Study Chair: Mustafa Younis, lecturer Sohag University
Study Chair: Mahmoud Mahmoud, lecturer Sohag University
Publications:
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Responsible Party: Mona Mohammed Abdelrhman, Principal investigator, Sohag University
ClinicalTrials.gov Identifier: NCT04763395    
Other Study ID Numbers: Soh-Med-21-02-27
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Mohammed Abdelrhman, Sohag University:
Liver function tests
Covid19
Severity
Additional relevant MeSH terms:
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Congenital Abnormalities