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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
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Vastra Gotaland
-
Gothenburg、Vastra Gotaland、瑞典、41345
- The Transplant Institute
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：0 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
0 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：3 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
3 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：6 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
6 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：9 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
9 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：12 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
12 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：15 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
15 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：18 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
18 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：21 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
21 months
|
|
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
大体时间：24 months
|
Cumulative presence of SARS-CoV-2 antibodies in plasma.
|
24 months
|
|
Change in levels of SARS-Cov-2 antibodies (antibody titers)
大体时间：0-24 months
|
Change in titers of SARS-CoV-2 antibodies in plasma over time.
|
0-24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
大体时间：3 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
3 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
大体时间：12 months
|
PBMC specific responses, measured in PCR/serology positive patients.
|
12 months
|
|
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
大体时间：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)
大体时间：0-24 months
|
Change in PBMC specific responses over time
|
0-24 months
|
|
Symptoms and hospitalisations (electronic questionnaire)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：24 months
|
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
|
24 months
|
合作者和调查者
调查人员
- 学习椅：Mihai Oltean, MD, PhD、Transplant Institute, Sahlgrenska University
- 首席研究员：John M Søfteland, MD, PhD、Transplant Institute, Sahlgrenska University
- 研究主任：Vanda Friman, MD, PhD、Department of Infectious diseases, Gothenburg University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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