COVID-19 is a global major public health emergency that disproportionately affectspatients with risk factors such as advanced age, heart and lung disease, diabetes,hypertension, as well as compromised immunity. Despite the recent worldwide emergence ofthis disease and its rapid progression to a pandemic, very little is known about therisks facing solid organ recipients. The study aims to elucidate the prevalence ofsymptomatic, subclinical, and asymptomatic infection in the transplanted population byassessing their immunological response to SARS-CoV-2 infection. This will be studiedseroepidemiologically in the whole cohort and retrospectively in transplanted patientsadmitted to hospital for COVID-19.Primary objective: to elucidate the cumulative prevalence of SARS-CoV-2 infection in thetransplanted population related to symptoms and hospitalizations; to assess the magnitudeof immunological response and seroconversion kinetics for COVID-19. Secondary objectives:To examine the influence of medical parameters on COVID-19 infection and immune responsesuch as: age, comorbidities current and recent pharmacological treatment, organtransplanted, 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
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.
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.
The Transplant Institute
Gothenburg, Vastra Gotaland, Sweden