COVID-19 Research in Organ Transplant Recipients (CORONA)
COVID-19 is a global major public health emergency that disproportionately affects patients with risk factors such as advanced age, heart and lung disease, diabetes, hypertension, as well as compromised immunity. Despite the recent worldwide emergence of this disease and its rapid progression to a pandemic, very little is known about the risks facing solid organ recipients. The study aims to elucidate the prevalence of symptomatic, subclinical, and asymptomatic infection in the transplanted population by assessing their immunological response to SARS-CoV-2 infection. This will be studied seroepidemiologically in the whole cohort and retrospectively in transplanted patients admitted to hospital for COVID-19.
Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in the transplanted population related to symptoms and hospitalizations; to assess the magnitude of immunological response and seroconversion kinetics for COVID-19. Secondary objectives: To examine the influence of medical parameters on COVID-19 infection and immune response such as: age, comorbidities current and recent pharmacological treatment, organ transplanted, and blood type, HLA genotype.
Study design:
Part 1: Longitudinal cohort study for seroepidemiology and disease burden. Part 2: Retrospective case-series for seroconversion kinetics and clinical course assessment.
Study population:
All solid organ transplanted patients in Sweden
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The study will assess the clinical course, the outcome, and the immunologic response of organ transplant patients who have had COVID-19 (participants); The investigators aim to study the development of the immune response to COVID-19 infection to see if participants on immunosuppressive treatment, will establish sufficient immunity to protect against reinfection. The findings among participants will be compared to a suitable control population. In addition, the investigators will identify patients in our cohort who are undergoing clinically apparent infections and study their clinical course and antibody response profile in the acute phase (seroconversion).
Control groups: Other current studies with matched protocols and WHO pooled data.
Overall study design Part 1: Potential participants are all patients who have undergone solid organ transplantation (SOT) in Sweden will be invited to participate in the longitudinal cohort seroprevalence part of the study (approximately 1000 patients will be included). This part of the study is a single-center longitudinal cohort study that will evaluate the development of antibodies against SARS-CoV-2 in solid organ recipients at all stages after transplantation and study their disease course, complications, and death rate.
The study has been designed to follow the best practices outlined by the WHO in their recent guidelines entitled "Population-based age-stratified seroepidemiological investigation protocol for COVID-19 virus infection COVID-19 v1.1". This will allow a comparison of symptoms, outcomes, case fatality rate, as well as antibody titers and prevalence, with other relevant control groups. Participant enrollment will be allowed for a maximum of 2 years. The duration of the study will be two years from enrollment. The last participant will thus complete follow-up a maximum of 4 years after the commencement of the study Part 2: The investigators will also do a retrospective assessment of transplanted patients in Sweden with PCR confirmed COVID-19.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
-
-
Vastra Gotaland
-
Gothenburg, Vastra Gotaland, Suède, 41345
- The Transplant Institute
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- A patient who has undergone solid organ transplantation in Sweden
- Must be able to take part in data reporting activities, sign the consent form, and submit blood samples at predefined intervals.
Exclusion Criteria:
-Patients under 18 years of age.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 0 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
0 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 3 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
3 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 6 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
6 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 9 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
9 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 12 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
12 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 15 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
15 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 18 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
18 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 21 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
21 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Délai: 24 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
24 months
|
|
Change in levels of SARS-Cov-2 antibodies (antibody titers)
Délai: 0-24 months
|
Change in titers of SARS-CoV-2 antibodies in plasma over time.
|
0-24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Délai: 3 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
3 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Délai: 12 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
12 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Délai: 24 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
24 months
|
|
Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Délai: 0-24 months
|
Change in PBMC specific responses over time
|
0-24 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 0 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
0 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 3 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
3 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 6 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
6 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 9 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
9 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 12 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
12 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 15 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
15 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 18 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
18 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 21 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
21 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Délai: 24 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
24 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Mihai Oltean, MD, PhD, Transplant Institute, Sahlgrenska University
- Chercheur principal: John M Søfteland, MD, PhD, Transplant Institute, Sahlgrenska University
- Directeur d'études: Vanda Friman, MD, PhD, Department of Infectious diseases, Gothenburg University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- COV-19-SU-TX
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .