CORONA: COVID-19 Research in Organ Transplant Recipients

Sponsor

Vastra Gotaland Region (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04407221

Collaborator

(none)

1,100

Enrollment

Location

46.5

Anticipated Duration (Months)

23.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transplant Recipients

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COVID-19 Research in Organ Transplant Recipients

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [0 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [3 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [6 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [9 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [12 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [15 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [18 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [21 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) [24 months]
Cumulative presence of SARS-CoV-2 antibodies in plasma.
Change in levels of SARS-Cov-2 antibodies (antibody titers) [0-24 months]
Change in titers of SARS-CoV-2 antibodies in plasma over time.

Secondary Outcome Measures

Cellular response to SARS-Cov-2 (Th4 and Th8 levels) [3 months]
PBMC specific responses, measured in PCR/serology positive patients.
Cellular response to SARS-Cov-2 (Th4 and Th8 levels) [12 months]
PBMC specific responses, measured in PCR/serology positive patients.
Cellular response to SARS-Cov-2 (Th4 and Th8 levels) [24 months]
PBMC specific responses, measured in PCR/serology positive patients.
Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels) [0-24 months]
Change in PBMC specific responses over time
Symptoms and hospitalisations (electronic questionnaire) [0 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [3 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [6 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [9 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [12 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [15 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [18 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [21 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
Symptoms and hospitalisations (electronic questionnaire) [24 months]
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Transplant Institute	Gothenburg	Vastra Gotaland	Sweden	41345

Sponsors and Collaborators

Vastra Gotaland Region

Investigators

Study Chair: Mihai Oltean, MD, PhD, Transplant Institute, Sahlgrenska University
Principal Investigator: John M Søfteland, MD, PhD, Transplant Institute, Sahlgrenska University
Study Director: Vanda Friman, MD, PhD, Department of Infectious diseases, Gothenburg University