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COVID-19 Research in Organ Transplant Recipients

NCT04407221 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2021-01-05

No results posted yet for this study

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

Conditions

  • Transplant Recipients

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Mihai Oltean, MD, PhD · Transplant Institute, Sahlgrenska University

  • John M Søfteland, MD, PhD · Transplant Institute, Sahlgrenska University

  • Vanda Friman, MD, PhD · Department of Infectious diseases, Gothenburg University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04407221 on ClinicalTrials.gov