COVID-19 Research in Organ Transplant Recipients

NCT04407221 | Unknown

• 1 other identifier: COV-19-SU-TX
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 1

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

Conditions

Transplant Recipients

Keywords

Transplant Recipients; COVID-19 pandemic; COVID-19 virus; COVID-19 diagnostic testing

Outcome Measures

Primary Outcomes (10)

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  0 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  3 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  6 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  9 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  12 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  15 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  18 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  21 months

• Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)

  Cumulative presence of SARS-CoV-2 antibodies in plasma.

  24 months

• Change in levels of SARS-Cov-2 antibodies (antibody titers)

  Change in titers of SARS-CoV-2 antibodies in plasma over time.

  0-24 months

Secondary Outcomes (13)

• Cellular response to SARS-Cov-2 (Th4 and Th8 levels)

  3 months

• Cellular response to SARS-Cov-2 (Th4 and Th8 levels)

  12 months

• Cellular response to SARS-Cov-2 (Th4 and Th8 levels)

  24 months

• Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)

  0-24 months

• Symptoms and hospitalisations (electronic questionnaire)

  0 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who have received a solid organ transplant can be offered to take part in the study.

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 years of age.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

The Transplant Institute

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Part 1: Plasma for serology PBMC Part 2: Plasma for serology PBMC Urine Stool NP or sputum swab

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mihai Oltean, MD, PhD

  Transplant Institute, Sahlgrenska University

  STUDY CHAIR

• John M Søfteland, MD, PhD

  Transplant Institute, Sahlgrenska University

  PRINCIPAL INVESTIGATOR

• Vanda Friman, MD, PhD

  Department of Infectious diseases, Gothenburg University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant transplant surgeon

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 29, 2020
• Study Start: June 16, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)