Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients

May 30, 2020 updated by: Magdalena Salcedo

Development and Persistence of Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients in Comparison With Immunocompetent Patients

This is a prospective study analyzing the development of humoral immune response against SARS-Cov-2 in patients with previous Covid19: the aim is to compare the incidence, titration and evolution of IgG an IgM in a prospective cohort of liver transplant patients surviving to the first wave of Covid19, in comparison to not inmmunossupressed patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The liver transplant (HT) recipient population is more susceptible to infections than the general population. Few data are available regarding the incidence and clinical course of SARS-CoV-2 infection in this population, initially considered to be "high risk" regarding a possible higher incidence and severity of infection in these patients.

A prospective cohort of liver transplant recipient patients diagnosed with SARS-CoV-2 infection (Clinical Trials.gov Protocol Record HCB / 2020/0384) has been developed from SETH (Spanish Society for Liver Transplantation). This study aims to analyze the incidence and establish the clinical evolution of the infection in these patients. Initial data from the cohort, which includes 111 incidental cases diagnosed as of April 7, show a higher standardized incidence than the general population, but not higher mortality (data being published).

The chronic immunosuppression in t solid organ transplant patients could play a double role with respect to SARS-Cov-2 infection: on the one hand, it may condition a greater susceptibility and initial aggressiveness, in relation to itself viral effect, and in the other hand, it could protect by reducing the immune response that triggers the pulmonary and systemic inflammatory process.

After the initial Covid-19 outbreak, both in the general population and in immunosuppressed patients, the rate of specific IgM and IgG seroconversion against this coronavirus, and its protective capacity against reactivations or reinfections, are unknown. Therefore, it is a challenge for health organizations to identify the immune response in the population and to characterize its degree of protection, to adopt early measures to lessen the consequences of possible epidemic waves in the coming months.

Continuing with the prospective study of the cohort of liver transplant patients diagnosed with Covid-19 (SETH-Covid-19), already defined and composed of 91 living patients, the humoral immune response and its evolution in the first 12 months after initial infection. The cohort will incorporate the new incidental cases; A comparative study will be carried out with a contemporary cohort of non-immunosuppressed patients, controlled for age, gender and severity of the initial disease.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Not yet recruiting
        • Victor Fernández Alonso
        • Contact:
      • Madrid, Spain, 28009
        • Recruiting
        • Victor Fernández Alonso
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liver transplant and control patients (propensity score including age, sex, and severity of previous covid19 episode)

Description

Inclusion Criteria:

Patients recovered of covid 19 Informed Consent

Exclusion Criteria:

Chemotherapy on going Concomitant Autoimmune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Liver transplant patient after having Covid19
Adult Liver transplant patient who had survived to Covid19 in the first wave of the disease in Spain (disease until june 30th), in all the liver Transplant Units in Spain (24).
Diagnostic test: CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data
Other Names:
  • Nasopharyngeal PCR test of SARS-Cov-2
No immunosuppressed patient with previous Covid19
Not immunosuppressed patient who had survived to Covid19 in the first wave of the disease. These patient have been diagnosed and treated in the Hospital Gregorio Marañón (Madrid), before 30th June
Diagnostic test: CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data
Other Names:
  • Nasopharyngeal PCR test of SARS-Cov-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of IgG against SARS-CoV-2
Time Frame: one year
Proportion, Rate
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
Time Frame: 12 months
Titer
12 months
Reinfection of Covid-19
Time Frame: one year
Categoric Yes/Not
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months after Covid-19
Rate
12 months after Covid-19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magdalena Salcedo

Investigators

  • Principal Investigator: Magdalena Salcedo, MD PhD, Liver Transplantation Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2020

Primary Completion (Actual)

May 29, 2020

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sero-Covid19_TH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Multicenter study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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