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NCT Number: NCT04494776

SARS-COV-2 Infection 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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital do Rim

São Paulo, Aão Paulo, 04038-002, Brazil

Location status: Recruiting

About this 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 (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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: Up to 3 months after resolution

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

  2. Graft loss

    Time frame: Up to 3 months after resolution

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

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Helio Tedesco

CONTACT

[email protected]

+55 11 5087-8113

Monica Nakamura

CONTACT

+55 11 5087 8318

Sponsors and collaborators

Lead sponsor

Helio Tedesco Silva Junior

Other

Collaborators

  • Hospital do Rim e Hipertensão

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Jul 31, 2020
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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