Trials Sponsors Conditions Drugs Pricing

Conditions

Liver Transplantation SARS-CoV-2 Vaccination

Outcome Measures

Primary Outcomes (1)

Rate of positive antibody titer
\> 0.8 U/mL
Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Secondary Outcomes (2)

Rate of highly protective antibody titer
Between 30 and 120 ± 15 days after the completion of the vaccination cycle
Median antibody titer absolute value
Between 30 and 120 ± 15 days after the completion of the vaccination cycle

Study Arms (2)

tacrolimus-based immunosuppresion

The TAC-based group will include any patient on tacrolimus monotherapy and patients taking multiple IS medications with blood tacrolimus levels \> 5 ng/mL

Diagnostic Test: Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.

NON-tacrolimus-based immunosuppresion

The NON-TAC-based group will include any patient on TAC-free therapy and patient taking multiple IS medications with blood tacrolimus levels \< 5 ng/mL

Interventions

Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.Diagnostic test

Blood test to value the antibody response to vaccination

NON-tacrolimus-based immunosuppresiontacrolimus-based immunosuppresion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Liver transplant recipients who underwent SARS-CoV-2 vaccination (3 doses)

You may qualify if:

Liver transplanted patients \>18 years of age.

Sponsors & Collaborators

University of Rome Tor Vergata
Otherlead

Study Sites (1)

Policlinico Tor Vergata

Roma, 00100, Italy

Enrollment

61 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 5, 2022

Study Start

April 1, 2022

Actual (reported)

Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

tacrolimus-based immunosuppresion

NON-tacrolimus-based immunosuppresion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

tacrolimus-based immunosuppresion

NON-tacrolimus-based immunosuppresion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations