COVID-19NCT04998214
Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- liver function , prothrombin time , INR , US .
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Aug 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients older than 18 years old, 1 month post COVID 19 infection.
Who may be able to join
- Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration.
Who cannot join
- Patients less than 18 y.
- Patients with acute COVID 19.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed 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.
- Conditions
- COVID-19
- Being tested
- liver function , prothrombin time , INR , US .
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver function , prothrombin time , INR , US .Diagnostic test
analytic
| Study group | Role | What they receive |
|---|---|---|
| control group non cirrhotic | compare liver function 1m after COVID-19 and that at beginning of infection Receives: Diagnostic Test: liver function , prothrombin time , INR , US . | |
| cirrhotic patients | compare liver function 1m after COVID-19 and that at beginning of infection Receives: Diagnostic Test: liver function , prothrombin time , INR , US . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start19 Aug 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Mokhtar Salim, Assiut University
- Investigators
- Khaled Abu Bakr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998214
- Sponsor's protocol ID
- liver in COVID-19
- Status last verified
- Feb 2023
- First submitted
- 19 Mar 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32226286Fung 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.
PubMed 32172672Sultan 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.
PubMed 32247018
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT04998214
- Acronym / sponsor ID
- liver in COVID-19
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group non cirrhotic | – | Diagnostic Test: liver function , prothrombin time , INR , US .compare liver function 1m after COVID-19 and that at beginning of infection |
| cirrhotic patients | – | Diagnostic Test: liver function , prothrombin time , INR , US .compare liver function 1m after COVID-19 and that at beginning of infection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old, 1 month post COVID 19 infection.
Key inclusion criteria (1 listed)
- Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration.
Key exclusion criteria (2 listed)
- Patients less than 18 y.
- Patients with acute COVID 19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver function , prothrombin time , INR , US .analytic | Diagnostic test | cirrhotic patients, control group non cirrhotic |
Primary outcome
to evaluate the long term effect of COVID 19 on the liver
Time frame: 1 month
to evaluate the changes in liver function (bilirubin ,liver enzymes , albumin , prothrombin time and INR in patients post COVID_19
1 secondary outcome
: Effect of COVID 19 on diseased liver
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 32226286Ye 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.
- Background: PubMed 32172672Fung 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.
- Background: PubMed 32247018Sultan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Abu Bakr study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the long term effect of COVID 19 on the liver (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04998214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.