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COVID-19 Research in Organ Transplant Recipients (CORONA)

3. januar 2021 oppdatert av: 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

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

1100

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sverige
    • Vastra Gotaland
      • Gothenburg, Vastra Gotaland, Sverige, 41345
        • The Transplant Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vastra Gotaland Region

Etterforskere

  • Studiestol: Mihai Oltean, MD, PhD, Transplant Institute, Sahlgrenska University
  • Hovedetterforsker: John M Søfteland, MD, PhD, Transplant Institute, Sahlgrenska University
  • Studieleder: Vanda Friman, MD, PhD, Department of Infectious diseases, Gothenburg University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. juni 2020

Primær fullføring (Forventet)

1. mai 2024

Studiet fullført (Forventet)

1. mai 2024

Datoer for studieregistrering

Først innsendt

3. mai 2020

Først innsendt som oppfylte QC-kriteriene

27. mai 2020

Først lagt ut (Faktiske)

29. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • COV-19-SU-TX

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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