NCT04694573

Brief Summary

The Covid-19 Serum Study is a prospective case-control study in

  1. 1.kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after transplantation (TX) (POST-TX Covid-19 Serum Study)
  2. 2.patients receiving kidney or liver transplantation after having had a SARS-CoV-2 infection (PRE-TX Covid-19 Serum Study)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

December 28, 2020

Last Update Submit

January 15, 2021

Conditions

Covid19Kidney Transplant; ComplicationsKidney Transplant Failure and RejectionLiver Transplant; ComplicationsLiver Transplant Failure and Rejection

Keywords

Covid-19SARS-CoV-2Kidney TransplantationLiver Transplantationdonor-specific antibodiesdnDSA

Outcome Measures

Primary Outcomes (4)

  • Change in dnDSA development (PRE-TX Covid-19 Serum Study)

    Year 1, 2, 3, 5 after day of transplantation

  • Change in dnDSA development (POST-TX Covid-19 Serum Study)

    at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19

  • Graft Survival (PRE-TX Covid-19 Serum-Study)

    Year 1, 2, 3, 5 after day of transplantation

  • Graft Survival (Post-TX Covid-19 Serum-Study)

    at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19

Secondary Outcomes (2)

  • Incidence of graft rejection (PRE-TX Covid-19 Serum Study)

    Year 1, 2, 3, 5 after day of transplantation

  • Incidence of graft rejection (POST-TX Covid-19 Serum Study)

    at day 60-90 after being hospitalized due to Covid-19; 1,2,3,5 years after day of hospitalization due to Covid-19

Study Arms (4)

POST-TX Covid-19 Serum Study Case

Kidney or liver-transplanted patients being hospitalized due to an infection with SARS-CoV-2

POST-TX Covid-19 Serum Study Control

2 matched controls without SARS-CoV-2 infection after TX; matching according to * age (18-34, 35-59, 60-75 years) * sex * type of transplantation * time after transplantation (0-180, 181-365, 366-1095, 1096-2555, \>2555 days after TX)

PRE-TX Covid-19 Serum Study Case

Patients being kidney or liver-transplanted after having had an infection with SARS-CoV-2

PRE-TX Covid-19 Serum Study Control

2 matched controls without SARS-CoV-2 infection prior to TX; matching according to * age(18-34, 35-59, 60-75 years) * sex * type of transplantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney- or liver transplant recipients with a SARS-CoV-2 infection prior to transplantation (PRE-TX Covid-19 Serum Study) or a SARS-CoV-2 infection after transplantation (POST-TX Covid-19 Serum Study), 2 matched controls

You may qualify if:

  • Kidney-transplant recipients and full-size liver-recipients (de-novo or re-transplanted)
  • Participant or legal guardian is willing and able to give informed consent for participation in the trial
  • SARS-CoV-2 infection before transplantation (PRE-TX Covid-19 Serum Study) or after transplantation (POST-TX Covid-19 Serum Study)
  • Kidney or liver transplantation between Dec 17,2020 - Dec 17, 2021
  • Hospitalization due to SARS-CoV-2 infection in between Dec 17,2020 - Dec 17, 2021

You may not qualify if:

  • multi-organ transplant recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nierenzentrum Heidelberg

Heidelberg, DE, 69120, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum; EDTA

MeSH Terms

Conditions

COVID-19Rejection, Psychology

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesSocial BehaviorBehavior

Study Officials

  • Caner Suesal, Professor

    Institute of Immunology Heidelberg

    PRINCIPAL INVESTIGATOR

  • Christian Morath, Professor

    Department of Nephrology, Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caner Suesal, Professor

CONTACT

+49 (0) 6221 56-5545caner.suesal@med.uni-heidelberg.de

Christian Morath, Professor

CONTACT

+49 (0) 6221 91120christian.morath@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Institute of Immunology

Study Record Dates

First Submitted

December 28, 2020

First Posted

January 5, 2021

Study Start

December 28, 2020

Primary Completion

December 28, 2021

Study Completion

December 28, 2022

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

DE(1)