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COVID-19 Research in Organ Transplant Recipients (CORONA)

2021年1月3日 更新者：John Søfteland、Vastra Gotaland Region

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

調査の概要

状態

招待による登録

条件

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

1100

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • スウェーデン
    • Vastra Gotaland
      • Gothenburg、Vastra Gotaland、スウェーデン、41345
        • The Transplant Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：0 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
0 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：3 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
3 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：6 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
6 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：9 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
9 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：12 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
12 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：15 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
15 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：18 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
18 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：21 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
21 months
Seroprevalence of SARS-Cov-2 antibodies (positive antibody test)
時間枠：24 months
Cumulative presence of SARS-CoV-2 antibodies in plasma.
24 months
Change in levels of SARS-Cov-2 antibodies (antibody titers)
時間枠：0-24 months
Change in titers of SARS-CoV-2 antibodies in plasma over time.
0-24 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
時間枠：3 months
PBMC specific responses, measured in PCR/serology positive patients.
3 months
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
時間枠：12 months
PBMC specific responses, measured in PCR/serology positive patients.
12 months
Cellular response to SARS-Cov-2 (Th4 and Th8 levels)
時間枠：24 months
PBMC specific responses, measured in PCR/serology positive patients.
24 months
Change in cellular response to SARS-Cov-2 (Th4 and Th8 levels)
時間枠：0-24 months
Change in PBMC specific responses over time
0-24 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：0 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
0 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：3 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
3 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：6 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
6 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：9 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
9 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：12 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
12 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：15 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
15 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：18 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
18 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：21 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
21 months
Symptoms and hospitalisations (electronic questionnaire)
時間枠：24 months
Self-reported symptoms (WHO list of common COVID-19 symptoms) and hospitalisations during the past 3 months.
24 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Vastra Gotaland Region

捜査官

  • スタディチェア：Mihai Oltean, MD, PhD、Transplant Institute, Sahlgrenska University
  • 主任研究者：John M Søfteland, MD, PhD、Transplant Institute, Sahlgrenska University
  • スタディディレクター：Vanda Friman, MD, PhD、Department of Infectious diseases, Gothenburg University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年6月16日

一次修了 (予想される)

2024年5月1日

研究の完了 (予想される)

2024年5月1日

試験登録日

最初に提出

2020年5月3日

QC基準を満たした最初の提出物

2020年5月27日

最初の投稿 (実際)

2020年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月5日

QC基準を満たした最後の更新が送信されました

2021年1月3日

最終確認日

2021年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • COV-19-SU-TX

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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