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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04410471
Enrollment
300
Registered
2020-06-01
Start date
2020-05-29
Completion date
2021-06-30
Last updated
2020-06-02

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

Conditions

Covid19, Immune Response, Liver Transplant Infection, Mortality

Keywords

Humoral Immunity, Reinfection, IgG and IgM against SARS-CoV-2, Immunosuppression

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.

Interventions

DIAGNOSTIC_TESTCLIA of IgG and IgM against SARS-Cov-2

Report of clinical data

Sponsors

Magdalena Salcedo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

Inclusion criteria

Patients recovered of covid 19 Informed Consent

Exclusion criteria

Chemotherapy on going Concomitant Autoimmune diseases

Design outcomes

Primary

MeasureTime frameDescription
Incidence of IgG against SARS-CoV-2one yearProportion, Rate

Secondary

MeasureTime frameDescription
titration and evolution of humoral response (IgG) along first 12 months after having Covid-1912 monthsTiter
Reinfection of Covid-19one yearCategoric Yes/Not

Other

MeasureTime frameDescription
Mortality12 months after Covid-19Rate

Countries

Spain

Contacts

Primary ContactMagdalena Salcedo, MD PhD
magdalena.salcedo@salud.madrid.org+34609751256
Backup ContactMaricela Valerio, MD
maricela.valerio@salud.madrid.org+34915866687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026