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

NCT04494776 | Recruiting

• 1 other identifier: 30631820.0.1001.8098
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection; Kidney Transplant Infection

Keywords

SARS-CoV-2 Infection; Kidney Transplant Infection; Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• Death

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

  Up to 3 months after resolution

• Graft loss

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

  Up to 3 months after resolution

Secondary Outcomes (1)

• Hospitalization

  Until discharge date, an average of 1 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 kidney transplant recipients confirmed by diagnostic test.

You may qualify if:

• 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.

Sponsors & Collaborators

• Helio Tedesco Silva Junior: lead
• Hospital do Rim e Hipertensão: collaborator

Study Sites (1)

Hospital do Rim

São Paulo, Aão Paulo, 04038-002, Brazil

RECRUITING

Related Publications (7)

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Conti P, Ronconi G, Caraffa A, Gallenga CE, Ross R, Frydas I, Kritas SK. Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies. J Biol Regul Homeost Agents. 2020 March-April,;34(2):327-331. doi: 10.23812/CONTI-E.

  PMID: 32171193 BACKGROUND

• D'Antiga L. Coronaviruses and Immunosuppressed Patients: The Facts During the Third Epidemic. Liver Transpl. 2020 Jun;26(6):832-834. doi: 10.1002/lt.25756. Epub 2020 Apr 24. No abstract available.

  PMID: 32196933 BACKGROUND

• Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available.

  PMID: 32066541 BACKGROUND

• Zhu L, Xu X, Ma K, Yang J, Guan H, Chen S, Chen Z, Chen G. Successful recovery of COVID-19 pneumonia in a renal transplant recipient with long-term immunosuppression. Am J Transplant. 2020 Jul;20(7):1859-1863. doi: 10.1111/ajt.15869. Epub 2020 Mar 31.

  PMID: 32181990 BACKGROUND

• Guillen E, Pineiro GJ, Revuelta I, Rodriguez D, Bodro M, Moreno A, Campistol JM, Diekmann F, Ventura-Aguiar P. Case report of COVID-19 in a kidney transplant recipient: Does immunosuppression alter the clinical presentation? Am J Transplant. 2020 Jul;20(7):1875-1878. doi: 10.1111/ajt.15874. Epub 2020 Apr 9.

  PMID: 32198834 BACKGROUND

• Modelli de Andrade LG, de Sandes-Freitas TV, Requiao-Moura LR, Viana LA, Cristelli MP, Garcia VD, Alcantara ALC, Esmeraldo RM, Abbud Filho M, Pacheco-Silva A, de Lima Carneiro ECR, Manfro RC, Costa KMAH, Simao DR, de Sousa MV, Santana VBBM, Noronha IL, Romao EA, Zanocco JA, Arimatea GGQ, De Boni Monteiro de Carvalho D, Tedesco-Silva H, Medina-Pestana J; COVID-19-KT Brazil. Development and validation of a simple web-based tool for early prediction of COVID-19-associated death in kidney transplant recipients. Am J Transplant. 2022 Feb;22(2):610-625. doi: 10.1111/ajt.16807. Epub 2021 Sep 2.

  PMID: 34416075 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jose Osmar Medina

  Hospital do Rim

  STUDY DIRECTOR

Central Study Contacts

Helio Tedesco

CONTACT

+55 11 5087-8113; heliotedesco@medfarm.com.br

Monica Nakamura

CONTACT

+55 11 5087 8318

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 31, 2020
• Study Start: May 21, 2020
• Primary Completion: December 3, 2022
• Study Completion: April 2, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)