Solid Organ Transplant Recipients With SARS-CoV-2 French Registry (TX-COVID)

April 30, 2020 updated by: University Hospital, Strasbourg, France

Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France

Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de Néphrologie et Transplantation
        • Principal Investigator:
          • Sophie CAILLARD, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samira FAFI-KREMER, MD, PhD
        • Sub-Investigator:
          • Gabriela GAUTIER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection

Description

Inclusion Criteria:

  • All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
  • Adult and pediatric

Exclusion Criteria:

- There are no exclusion criteria, except for the patient's explicit refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients
Time Frame: From 1st March 2020 to 1st March 2021
From 1st March 2020 to 1st March 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Study Director: Sophie CAILLARD, MD, PhD, Service de Néphrologie et Transplantation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Anticipated)

April 8, 2021

Study Completion (Anticipated)

April 8, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

May 5, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7766

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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