SARS-COV-2 Infection in Kidney Transplant Recipients: a Brazilian Multicenter Study

March 17, 2022 updated by: Helio Tedesco Silva Junior

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Infection (COVID-19) in Kidney Transplant Recipients: a Brazilian Multicenter Study

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in a national multicenter cohort.

Study Overview

Status

Recruiting

Conditions

Detailed Description

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highly contagious viral disease, the condition of which main clinical symptoms are characterized by fever and respiratory symptoms. Evidence indicates to worse outcomes in patients with pre-existing diseases, such as diabetes, arterial hypertension, heart disease, pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidney transplants make prolonged use of immunosuppressive drugs to inhibit the acquired immune response, notably the activity of lymphocytes. Due to this potential to modulate the immune and inflammatory response, it is speculated that the clinical and laboratory condition of COVID-19 in these patients is atypical. Preliminary evidence suggests worse outcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However, information on kidney transplant recipients is insufficient. So far, only reports of the case are available in the literature with different clinical presentations and outcomes. The aim of this study is, therefore, to characterize the demographics, clinical and laboratory conditions (mechanical ventilation, need for dialysis, need for ICU admission during evolution) and the outcomes of COVID-19 (death and graft loss within 3 months after infection up to 3 months after resolution) in kidney transplant recipients in a national multicenter cohort.Inclusion Criteria:1. Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period; 2. Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies); 3.Outpatient or hospital management; 4.Adults and children. Exclusion Criteria: None

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Monica Nakamura
  • Phone Number: +55 11 5087 8318

Study Locations

  • Brazil
    • Aão Paulo
      • São Paulo, Aão Paulo, Brazil, 04038-002
        • Recruiting
        • Hospital do Rim

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 kidney transplant recipients confirmed by diagnostic test.

Description

Inclusion Criteria:

  1. Kidney transplant recipients, which may be multi-organ recipients, transplanted in any follow-up period;
  2. Positive diagnostic test for COVID-19 (detection of viral load, test for detection of antigens or tests for detection of antibodies);
  3. Outpatient or hospital management;
  4. Adults and children.

Exclusion Criteria:

-

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
Measure Description
Time Frame
Death
Time Frame: Up to 3 months after resolution
Death within 3 months after infection (Yes/No).
Up to 3 months after resolution
Graft loss
Time Frame: Up to 3 months after resolution
Graft loss up to 3 months after infection (Yes/No).
Up to 3 months after resolution

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization
Time Frame: Until discharge date, an average of 1 month
Composite outcomes: Mechanical ventilation (Yes/No); Need for dialysis (Yes/No); Need for ICU admission during evolution (Yes/No).
Until discharge date, an average of 1 month

Collaborators and Investigators

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

Sponsor

Helio Tedesco Silva Junior

Collaborators

Hospital do Rim e Hipertensão

Investigators

  • Study Director: Jose Osmar Medina, Hospital do Rim

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)

May 21, 2020

Primary Completion (Anticipated)

December 3, 2022

Study Completion (Anticipated)

April 2, 2023

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30631820.0.1001.8098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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