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Clinical Trials/NCT04494776
NCT04494776
Recruiting
Not Applicable

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

Helio Tedesco Silva Junior1 site in 1 country500 target enrollmentMay 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV-2 Infection
Sponsor
Helio Tedesco Silva Junior
Enrollment
500
Locations
1
Primary Endpoint
Graft loss
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
May 21, 2020
End Date
April 2, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Helio Tedesco Silva Junior
Responsible Party
Sponsor Investigator
Principal Investigator

Helio Tedesco Silva Junior

Principal Investigator

Hospital do Rim e Hipertensão

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Graft loss

Time Frame: Up to 3 months after resolution

Graft loss up to 3 months after infection (Yes/No).

Death

Time Frame: Up to 3 months after resolution

Death within 3 months after infection (Yes/No).

Secondary Outcomes

  • Hospitalization(Until discharge date, an average of 1 month)

Study Sites (1)

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