Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease (NCT05107271) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease
India252 participantsStarted 2021-11-15
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Long haul COVID-19 related symptoms
Timeframe: 1 year
2
Immunogenicity of vaccine
Timeframe: 1 year
Trial details
NCT IDNCT05107271
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh