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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04410471
• Other study ID #: Sero-Covid19_TH
• Status: Recruiting
• Start date: May 29, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: May 2020
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Magdalena Salcedo, MD PhD
• Phone: +34609751256
• Email: magdalena.salcedo[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2021
• Est. primary completion date: May 29, 2020
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Patients recovered of covid 19 Informed Consent

Exclusion Criteria:

Chemotherapy on going Concomitant Autoimmune diseases

Related Conditions & MeSH terms

• Covid19
• Immune Response
• Liver Transplant Infection
• Mortality

Intervention

Diagnostic Test:
• CLIA of IgG and IgM against SARS-Cov-2
Report of clinical data

Locations

Country	Name	City	State
Spain	Victor Fernandez Alonso	Madrid
Spain	Victor Fernández Alonso	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Magdalena Salcedo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Rate	12 months after Covid-19
Primary	Incidence of IgG against SARS-CoV-2	Proportion, Rate	one year
Secondary	titration and evolution of humoral response (IgG) along first 12 months after having Covid-19	Titer	12 months
Secondary	Reinfection of Covid-19	Categoric Yes/Not	one year