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
1 other identifier
observational
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJune 2, 2020
May 1, 2020
Same day
May 29, 2020
May 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of IgG against SARS-CoV-2
Proportion, Rate
one year
Secondary Outcomes (2)
titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
12 months
Reinfection of Covid-19
one year
Other Outcomes (1)
Mortality
12 months after Covid-19
Study Arms (2)
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).
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
Interventions
Report of clinical data
Eligibility Criteria
Liver transplant and control patients (propensity score including age, sex, and severity of previous covid19 episode)
You may qualify if:
- Patients recovered of covid 19 Informed Consent
You may not qualify if:
- Chemotherapy on going Concomitant Autoimmune diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Victor Fernandez Alonso
Madrid, 28009, Spain
Victor Fernández Alonso
Madrid, 28009, Spain
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magdalena Salcedo, MD PhD
Liver Transplantation Unit
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician, Hepatology
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 1, 2020
Study Start
May 29, 2020
Primary Completion
May 29, 2020
Study Completion
June 30, 2021
Last Updated
June 2, 2020
Record last verified: 2020-05