Liver Function Test Abnormalities in COVID-19

NCT04763395 | Completed

• 1 other identifier: Soh-Med-21-02-27
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Function Tests Abnormalities

Keywords

Liver function tests; Covid19; Severity

Outcome Measures

Primary Outcomes (3)

• 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

• Risk factors of Liver function test abnormalities

  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

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention

Severe Covid19; non-severe COVID19

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with Covid19 positive PCR.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Mona Mohammed Abdelrhman

Sohag, Egypt

Location

Related Publications (4)

• Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17.

  PMID: 32081636 BACKGROUND

• Mao R, Liang J, Shen J, Ghosh S, Zhu LR, Yang H, Wu KC, Chen MH; Chinese Society of IBD, Chinese Elite IBD Union; Chinese IBD Quality Care Evaluation Center Committee. Implications of COVID-19 for patients with pre-existing digestive diseases. Lancet Gastroenterol Hepatol. 2020 May;5(5):425-427. doi: 10.1016/S2468-1253(20)30076-5. Epub 2020 Mar 11. No abstract available.

  PMID: 32171057 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4. No abstract available.

  PMID: 32145190 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Asmaa Mahmoud, lecturer

  Sohag University

  STUDY CHAIR

• Mustafa Younis, lecturer

  Sohag University

  STUDY CHAIR

• Mahmoud Mahmoud, lecturer

  Sohag University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: January 29, 2021
• Primary Completion: February 20, 2021
• Study Completion: March 1, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

EG (1)