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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Vastra Gotaland
-
Gothenburg, Vastra Gotaland, Szwecja, 41345
- The Transplant Institute
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 0 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
0 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 3 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
3 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 6 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
6 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 9 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
9 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 12 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
12 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 15 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
15 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 18 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
18 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 21 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
21 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
Ramy czasowe: 24 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
24 months
|
|
Change in levels of SARS-Cov-2 antibodies (antibody titers)
Ramy czasowe: 0-24 months
|
Change in titers of SARS-CoV-2 antibodies in plasma over time.
|
0-24 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Ramy czasowe: 3 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
3 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Ramy czasowe: 12 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
12 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
Ramy czasowe: 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)
Ramy czasowe: 0-24 months
|
Change in PBMC specific responses over time
|
0-24 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 24 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
24 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Mihai Oltean, MD, PhD, Transplant Institute, Sahlgrenska University
- Główny śledczy: John M Søfteland, MD, PhD, Transplant Institute, Sahlgrenska University
- Dyrektor Studium: Vanda Friman, MD, PhD, Department of Infectious diseases, Gothenburg University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- COV-19-SU-TX
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Biorcy przeszczepów
-
Abramson Cancer Center of the University of PennsylvaniaWycofanePacjenci z chorobą nowotworową poddawani przeszczepowi komórek macierzystych (RCT of ACP for Transplant)