NCT04998214

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

August 19, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

March 19, 2021

Last Update Submit

February 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • : Effect of COVID 19 on diseased liver

    1 month

Study Arms (2)

control group non cirrhotic

compare liver function 1m after COVID-19 and that at beginning of infection

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

cirrhotic patients

compare liver function 1m after COVID-19 and that at beginning of infection

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

Interventions

analytic

cirrhotic patientscontrol group non cirrhotic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 18 years old, 1 month post COVID 19 infection.

You may qualify if:

  • Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration.

You may not qualify if:

  • Patients less than 18 y.
  • Patients with acute COVID 19.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 32226286BACKGROUND
  • 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.

    PMID: 32172672BACKGROUND
  • 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.

    PMID: 32247018BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Prothrombin TimeInternational Normalized Ratio

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Khaled Abu Bakr

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor : Mohammed El Taher Abdel Rahman .

Study Record Dates

First Submitted

March 19, 2021

First Posted

August 10, 2021

Study Start

August 19, 2021

Primary Completion

April 1, 2023

Study Completion

April 30, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations