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NCT04998214 Clinical Trial

Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

COVID-19 Clinical Trial

Official title:
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04998214
Other study ID # liver in COVID-19
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 19, 2021
Est. completion date April 30, 2023

Study information
Verified date February 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients. To compare the hepatic manifestations in post COVID -19 patients with and without liver disease

Description:

The digestive tract, particularly the liver, has recently been reported to be affected by SARS-CoV-2. Although abnormal liver enzymes were regularly described as an extra-pulmonary clinical feature, and almost one half of patients experienced grades of hepatic injury. liver damage in patients with SARS infections was primarily manifested in the mild and moderate elevation of alanine and/or aspartate aminotransferases (ALT and AST) with some degree of hypoalbuminemia and hyperbilirubinemia during the early stage of the illness.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 65
Est. completion date April 30, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration. Exclusion Criteria: - Patients less than 18 y. - Patients with acute COVID 19.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• liver function , prothrombin time , INR , US .
analytic

Locations
Country Name City State
Egypt Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Fung SY, Yuen KS, Ye ZW, Chan CP, Jin DY. A tug-of-war between severe acute respiratory syndrome coronavirus 2 and host antiviral defence: lessons from other pathogenic viruses. Emerg Microbes Infect. 2020 Mar 14;9(1):558-570. doi: 10.1080/22221751.2020.1736644. eCollection 2020. — View Citation

Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, Falck-Ytter Y, El-Serag HB; AGA Institute. Electronic address: ewilson@gastro.org. AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic. Gastroenterology. 2020 Aug;159(2):739-758.e4. doi: 10.1053/j.gastro.2020.03.072. Epub 2020 Apr 1. No abstract available. — View Citation

Ye ZW, Yuan S, Yuen KS, Fung SY, Chan CP, Jin DY. Zoonotic origins of human coronaviruses. Int J Biol Sci. 2020 Mar 15;16(10):1686-1697. doi: 10.7150/ijbs.45472. eCollection 2020. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate the long term effect of COVID 19 on the liver to evaluate the changes in liver function (bilirubin ,liver enzymes , albumin , prothrombin time and INR in patients post COVID_19 1 month
Secondary : Effect of COVID 19 on diseased liver to evaluate the changes in liver function(bilirubin , liver enzymes , albumin , prothrombin time , INR) in cirrhotic post COVID_19 1 month
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