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Transplant RecipientsCORONANCT04407221

COVID-19 Research in Organ Transplant Recipients

An observational study of Transplant Recipients, run by Vastra Gotaland Region at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Transplant Recipients
How many people
1,100 participants
Where
1 siteSweden
Study dates
16 Jun 2020to 1 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • -Patients under 18 years of age.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • The Transplant Institute

    Gothenburg, Västra Götaland County, 41345

Other trials in Sweden

About this study

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.

Read more

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

Read the 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.

Keywords
Transplant Recipients, COVID-19 pandemic, COVID-19 virus, COVID-19 diagnostic testing
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 0 months

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

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

    Measured: 3 months

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

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

    Measured: 6 months

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

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

    Measured: 9 months

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

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

    Measured: 12 months

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

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

    Measured: 15 months

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

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

    Measured: 18 months

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

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

    Measured: 21 months

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

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

    Measured: 24 months

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

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

    Measured: 0-24 months

Secondary outcomes (13)

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

    PBMC specific responses, measured in PCR/serology positive patients.

    Measured: 3 months

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

    PBMC specific responses, measured in PCR/serology positive patients.

    Measured: 12 months

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

    PBMC specific responses, measured in PCR/serology positive patients.

    Measured: 24 months

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

    Change in PBMC specific responses over time

    Measured: 0-24 months

  5. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 0 months

  6. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 3 months

  7. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 6 months

  8. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 9 months

  9. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 12 months

  10. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 15 months

  11. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 18 months

  12. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 21 months

  13. Symptoms and hospitalisations (electronic questionnaire)

    Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2020
  2. Study start16 Jun 2020
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04407221
Sponsor's protocol ID
COV-19-SU-TX
Acronym
CORONA
Status last verified
Jan 2021
First submitted
3 May 2020
Last updated
5 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Transplant Recipients, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroprevalence of SARS-Cov-2 antibodies (positive antibody test) (time frame: 0 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04407221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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