- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04410471
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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Madrid, Spania, 28009
- Har ikke rekruttert ennå
- Victor Fernández Alonso
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Ta kontakt med:
- Victor Fernandez Alonso
- Telefonnummer: +34915866687
- E-post: victor.fernandez@iisgm.com
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Madrid, Spania, 28009
- Rekruttering
- Victor Fernández Alonso
-
Ta kontakt med:
- Victor Fernández, Nurse
- Telefonnummer: +34915866687
- E-post: victor.fernandez@iisgm.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
Patients recovered of covid 19 Informed Consent
Exclusion Criteria:
Chemotherapy on going Concomitant Autoimmune diseases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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).
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Report of clinical data
Andre navn:
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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
|
Report of clinical data
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of IgG against SARS-CoV-2
Tidsramme: one year
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Proportion, Rate
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one year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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titration and evolution of humoral response (IgG) along first 12 months after having Covid-19
Tidsramme: 12 months
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Titer
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12 months
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Reinfection of Covid-19
Tidsramme: one year
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Categoric Yes/Not
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one year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality
Tidsramme: 12 months after Covid-19
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Rate
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12 months after Covid-19
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Magdalena Salcedo, MD PhD, Liver Transplantation Unit
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Sero-Covid19_TH
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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