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
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Várható)
Kapcsolatok és helyek
Tanulmányi helyek
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Vastra Gotaland
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Gothenburg, Vastra Gotaland, Svédország, 41345
- The Transplant Institute
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 0 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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0 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 3 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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3 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 6 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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6 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 9 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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9 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 12 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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12 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 15 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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15 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 18 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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18 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 21 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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21 months
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Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Időkeret: 24 months
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Cumulative presence of SARS-CoV-2 antibodies in plasma.
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24 months
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Change in levels of SARS-Cov-2 antibodies (antibody titers)
Időkeret: 0-24 months
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Change in titers of SARS-CoV-2 antibodies in plasma over time.
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0-24 months
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Időkeret: 3 months
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PBMC specific responses, measured in PCR/serology positive patients.
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3 months
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Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Időkeret: 12 months
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PBMC specific responses, measured in PCR/serology positive patients.
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12 months
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Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Időkeret: 24 months
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PBMC specific responses, measured in PCR/serology positive patients.
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24 months
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Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Időkeret: 0-24 months
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Change in PBMC specific responses over time
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0-24 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 0 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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0 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 3 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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3 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 6 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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6 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 9 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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9 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 12 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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12 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 15 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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15 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 18 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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18 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 21 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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21 months
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Symptoms and hospitalisations (electronic questionnaire)
Időkeret: 24 months
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Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
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24 months
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Mihai Oltean, MD, PhD, Transplant Institute, Sahlgrenska University
- Kutatásvezető: John M Søfteland, MD, PhD, Transplant Institute, Sahlgrenska University
- Tanulmányi igazgató: Vanda Friman, MD, PhD, Department of Infectious diseases, Gothenburg University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Várható)
A tanulmány befejezése (Várható)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- COV-19-SU-TX
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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