Liver Transplant InfectionNCT04410471
Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients After COVID-19 in Comparison With Immunocompetent Patients
An observational study of Liver Transplant Infection and Covid19, run by Magdalena Salcedo at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Transplant Infection, Covid19, Mortality
- What is being tested?
- CLIA of IgG and IgM against SARS-Cov-2
- How many people
- 300 participants
- Where
- 2 sitesSpain
- Study dates
- 29 May 2020to 30 Jun 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Liver transplant and control patients (propensity score including age, sex, and severity of previous covid19 episode)
Who may be able to join
- Patients recovered of covid 19 Informed Consent
Who cannot join
- Chemotherapy on going Concomitant Autoimmune diseases
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Not yet recruiting
Victor Fernandez Alonso
Madrid, 28009
Victor Fernandez Alonso, +34915866687, victor.fernandez@iisgm.com
- Recruiting
Victor Fernández Alonso
Madrid, 28009
Victor Fernández, Nurse, +34915866687, victor.fernandez@iisgm.com
About this study
Official title: Development and Persistence of Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients in Comparison With Immunocompetent Patients
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.
Read the 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.
- Conditions
- Liver Transplant Infection, Covid19, Mortality, Immune Response
- Being tested
- CLIA of IgG and IgM against SARS-Cov-2
- Keywords
- Humoral Immunity, Reinfection, IgG and IgM against SARS-CoV-2, Immunosuppression
- Medical subject headings
- COVID-19, Reinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIA of IgG and IgM against SARS-Cov-2Diagnostic test
Also called Nasopharyngeal PCR test of SARS-Cov-2
Report of clinical data
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: CLIA of IgG and IgM against SARS-Cov-2 | |
| 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 Receives: Diagnostic Test: CLIA of IgG and IgM against SARS-Cov-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IgG against SARS-CoV-2
Proportion, Rate
Measured: one year
Secondary outcomes (2)
titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
Titer
Measured: 12 months
Reinfection of Covid-19
Categoric Yes/Not
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start29 May 2020
- Primary completion29 May 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Magdalena Salcedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Magdalena Salcedo, Hospital General Universitario Gregorio Marañon
- Investigators
- Magdalena Salcedo, MD PhD, Principal investigator, Liver Transplantation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410471
- Sponsor's protocol ID
- Sero-Covid19_TH
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Multicenter study
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Persistence of Humoral Immunity Against SARS-CoV-2 in Liver Transplanted Patients in Comparison With Immunocompetent Patients
- ClinicalTrials.gov ID
- NCT04410471
- Acronym / sponsor ID
- Sero-Covid19_TH
- Conditions
- Liver Transplant Infection, Covid19, Mortality, Immune Response
- Keywords
- Humoral Immunity, Reinfection, IgG and IgM against SARS-CoV-2, Immunosuppression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Magdalena SalcedoUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver transplant patient after having Covid19 | – | Diagnostic Test: CLIA of IgG and IgM against SARS-Cov-2Adult 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 | – | Diagnostic Test: CLIA of IgG and IgM against SARS-Cov-2Not 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Liver transplant and control patients (propensity score including age, sex, and severity of previous covid19 episode)
Key inclusion criteria (1 listed)
- Patients recovered of covid 19 Informed Consent
Key exclusion criteria (1 listed)
- Chemotherapy on going Concomitant Autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLIA of IgG and IgM against SARS-Cov-2Also: Nasopharyngeal PCR test of SARS-Cov-2Report of clinical data | Diagnostic test | Liver transplant patient after having Covid19, No immunosuppressed patient with previous Covid19 |
Primary outcome
Incidence of IgG against SARS-CoV-2
Time frame: one year
Proportion, Rate
2 secondary outcomes
titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
Time frame: 12 months
Reinfection of Covid-19
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: Undecided. Multicenter study
Related trials for Liver Transplant Infection
Not yet recruitingPhase 2
A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients
Hepatitis B Virus, Liver Transplant
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
RecruitingObservational study
Immune Biomarkers for Predicting Complications After Liver Transplantation
Liver Transplantation (LT), Immuno-suppression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Salcedo, MD PhD principal investigator
Liver Transplantation Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Infection and Covid19, run by Magdalena Salcedo at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Salcedo, MD PhD (+34609751256, magdalena.salcedo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of IgG against SARS-CoV-2 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020; AzTrials last refreshed its copy on 7 Nov 2026.