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

• Conditions: Mortality; Liver Transplant Infection; Covid19; Immune Response
• Interventions: Diagnostic Test: CLIA of IgG and IgM against SARS-Cov-2

• Registration Number: NCT04410471
• Lead Sponsor: Magdalena Salcedo

Brief Summary

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.

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 Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-29
• Primary Completion: 2020-05-29
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-30
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-02
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients recovered of covid 19 Informed Consent

Exclusion Criteria

Chemotherapy on going Concomitant Autoimmune diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No immunosuppressed patient with previous Covid19	CLIA of IgG and IgM against SARS-Cov-2	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
Liver transplant patient after having Covid19	CLIA of IgG and IgM against SARS-Cov-2	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).

Primary Outcome Measures

Name	Time	Method
Incidence of IgG against SARS-CoV-2	one year	Proportion, Rate

Secondary Outcome Measures

Name	Time	Method
titration and evolution of humoral response (IgG) along first 12 months after having Covid-19	12 months	Titer
Reinfection of Covid-19	one year	Categoric Yes/Not

Trial Locations

Locations (2)

Victor Fernandez Alonso; 🇪🇸 Madrid, Spain

Victor Fernández Alonso; 🇪🇸 Madrid, Spain