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 range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. The person is between the ages of 18-75 years at the time of signing the informed consent form.
ā. Individual has chronic liver disease of any etiology and is attached to the Hepatology services of the PGIMER, Chandigarh.
ā. 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.
ā. 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.
ā. 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).
Exclusion criteria
ā. Subject is unable to provide informed consent or to comply with study requirements.
ā
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