COvid-19 vaccination and Biomarkers in cirrhosis And post-Liver Transplantation

COvid-19 vaccination and Biomarkers in cirrhosis And post-Liver Transplantation - COBALT

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51899

Enrollment

120

Registered

2021-07-16

Start date

2021-07-18

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus infection Covid-19

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: i) Participant able to give written informed consent ii) Diagnosis of: a. Cirrhosis (on imaging or liver biopsy), or, b. Autoimmune liver disease (PSC, PBC or AIH) without cirrhosis, or c. Post-LT for cirrhosis >6 months, or d. Healthy participant (absence of severe and uncontrolled cardiac, respiratory, liver, renal or endocrine disease in opinion of PI or sub-I, see appendix 1). iii) Age >18 years

Exclusion criteria

Exclusion criteria: i) History of Covid-19 (PCR-positive episode) ii) Participant unable to give written informed consent iii) Uncontrolled HIV infection

Design outcomes

Primary

Measure	Time frame
To determine if patients with CLD mount comparable humoral immune responses to healthy controls at 8-months following SARS-CoV-2 vaccination.	—

Secondary

Measure	Time frame
- if there are differences in humoral immune response between subgroups with cirrhosis, autoimmune CLD or post-LT, - the minimum effective level of humoral immunity in cirrhosis, autoimmune CLD or post-LT to provide protection against Covid-19, - if there are adverse effects or toxicity from vaccination in the context of underlying cirrhosis, autoimmune CLD or post-LT, - the degree of humoral response to booster doses of Covid-19 vaccination, if these are administered as part of routine clinical car	—

Measure

Time frame

- if there are differences in humoral immune response between subgroups with cirrhosis, autoimmune CLD or post-LT, - the minimum effective level of humoral immunity in cirrhosis, autoimmune CLD or post-LT to provide protection against Covid-19, - if there are adverse effects or toxicity from vaccination in the context of underlying cirrhosis, autoimmune CLD or post-LT, - the degree of humoral response to booster doses of Covid-19 vaccination, if these are administered as part of routine clinical car

—

Countries

Netherlands

Outcome results