Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients
NCT ID: NCT04410471
Last Updated: 2020-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2020-05-29
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data
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
CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data
Interventions
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CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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Magdalena Salcedo
OTHER
Responsible Party
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Magdalena Salcedo
Attending Physician, Hepatology
Principal Investigators
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Magdalena Salcedo, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Liver Transplantation Unit
Locations
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Victor Fernandez Alonso
Madrid, , Spain
Victor Fernández Alonso
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Sero-Covid19_TH
Identifier Type: -
Identifier Source: org_study_id
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