NCT05107271Completed
Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease
Comprehensive Assessment of Intermediate and Long-term Sequelae of COVID-19 Infection and Immunological Correlates of Protection Induced by COVID-19 Vaccines in Patients With Liver Disease: A Prospective Cohort Study.
Source: ClinicalTrials.gov · Last updated 8 Jun 2025
Brief summary (registry, in English)
The project is essential to understand the impact of the COVID-19 pandemic in patients with Chronic Liver Disease (CLD). The impact has been felt due to direct risk of COVID infection in self, or in caregivers, lack of access to services during lockdown, interruptions in transplant listing and waitlist mortality. Briefly, the following points will be focused during the study. 1. Long haul COVID-19 related symptoms. 2. Impact on health and delay in interventions or drug therapy due to interruption of physical outpatient services. 3. Impact on emergency admissions due to refractory ascites, new decompensation, variceal bleeding etc 4. Impact on delayed transplant listing and waitlist mortality 5. Impact on post-transplant patients with lack of access to drug monitoring/ physical OPD 6. Impact on delay in interventions due to hepatobiliary malignancy. 7. Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients. 8. Determination of dose protocol and need for booster vaccination in patients with CLD and post liver transplant recipients.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 252 (actual)
- First submitted
- 3 Nov 2021
- Start date
- Nov 2021
- Primary completion date
- Dec 2022
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Diseases
- High blood pressure
- NCT number
- NCT05107271
What you commit to
- Study type: Observational
- Participants enrolled: 252
- From Nov 2021 to the primary completion date, Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subject has currently been diagnosed with active COVID-19 disease.
Other
- Subject is unable to provide informed consent or to comply with study requirements.
Who the study is looking for
- The person is between the ages of 18-75 years at the time of signing the informed consent form.
- Individual has chronic liver disease of any etiology and is attached to the Hepatology services of the PGIMER, Chandigarh.
- Individual has had a positive SARS-COV-02 test (PCR) within the last 12 months or has been diagnosed presumptive positive and has been treated for COVID-19 within the last 12 months.
- Individual has not fully recovered from COVID-19 in weeks or months despite a negative Sars-COV-02 test and has been diagnosed with Post COVID-19 syndrome.
- Individual is experiencing 2 or more symptoms for over 12 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms, or dramatic worsening of symptoms i.e., subject did not have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19, or the symptoms are dramatically worse (in severity and frequency).
- Extreme fatigue - feeling overtired with low energy and a strong desire to sleep.
- Shortness of breath - (dyspnea) a feeling of being winded, difficulty in breathing, or a hunger for air.
- Cough - hacking, or dry barking sound lingering dry or wet.
- Brain fog -a diminished mental capacity marked by the inability to concentrate or to think or reason clearly that interferes with daily activities.
- Headache - Sharp or dull reoccurring or intermittent that were not present pre-illness.
- Body aches - muscle soreness or generalized achiness throughout the body.
- Joint pain - pain in the joints due to inflammation not experienced before illness.
- Chest pain - (angina) feeling pressure, fullness, or tightness in your chest
- Sleep issues - any sleep disturbances in sleep quality that makes sleep see inadequate or unrefreshing like insomnia or hypersomnia.
- Loss of Taste/Smell - Diminished sense of taste or smell.
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PGIMER Coordinator of this site? Confirm its status | Chandigarh | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.