Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease

NCT05107271 | Completed DMC

• 1 other identifier: 2021-5859
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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. 1.Long haul COVID-19 related symptoms.
2. 2.Impact on health and delay in interventions or drug therapy due to interruption of physical outpatient services.
3. 3.Impact on emergency admissions due to refractory ascites, new decompensation, variceal bleeding etc
4. 4.Impact on delayed transplant listing and waitlist mortality
5. 5.Impact on post-transplant patients with lack of access to drug monitoring/ physical OPD
6. 6.Impact on delay in interventions due to hepatobiliary malignancy.
7. 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. 8.Determination of dose protocol and need for booster vaccination in patients with CLD and post liver transplant recipients.

Conditions

COVID-19; Chronic Liver Failure; Cirrhosis, Liver; Portal Hypertension; Liver Transplant Disorder

Outcome Measures

Primary Outcomes (2)

• Long haul COVID-19 related symptoms

  'Long-COVID-19' describes the long duration symptoms that patients who have recovered from COVID-19 continue to experience even in their post-recovery phase

  1 year

• Immunogenicity of vaccine

  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

  1 year

Study Arms (2)

Chronic Liver Disease

Diagnostic Test: COVID-19 serosurvey

Post Liver Transplantation

Diagnostic Test: COVID-19 serosurvey

Interventions

COVID-19 serosurvey DIAGNOSTIC_TEST

COVID-19 related antibody testing to assess immunogenicity of COVID-19 vaccines or post natural infection acquired immunity

Chronic Liver Disease; Post Liver Transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Liver Disease or those who are post LT recipients who are attached to the inpatient, outpatient, and telehealth services of the Department of Hepatology, PGIMER Chandigarh will be screened for inclusion

You may qualify if:

• 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.

You may not qualify if:

• Subject is unable to provide informed consent or to comply with study requirements.
• Subject has currently been diagnosed with active COVID-19 disease.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be assessed for serosurvey

MeSH Terms

Conditions

COVID-19; End Stage Liver Disease; Liver Cirrhosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Virendra Singh, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 4, 2021
• Study Start: November 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: March 15, 2024
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

IN (1)