NCT04511429

Brief Summary

Viral respiratory infections are common infectious complications after kidney transplantation, especially in the pediatric age group, and immunosuppressed patients may develop more severe disease. Immunosuppressive medications alter the patient's immune response by acting on humoral, cellular immunity and neutrophil function, increasing the risk of serious viral infections. Little is known about how these patients respond to infection by the new coronavirus (SARS-CoV-2). Experience with SARS caused by the Influenza H1N1 virus suggests that the severity of the disease depends on pre-existing comorbidities and the individual immune response. In more severe cases, an imbalance between the inflammatory system and the immune system is observed, determining direct consequences when pro and anti-inflammatory cytokines reach the systemic circulation in an exacerbated and unbalanced manner. Such fact can generate "cytokine storm syndrome", resulting in multiple organ dysfunction syndrome. March 2020 reports from Papa Giovanni XXIII Hospital in Bergamo, Italy - one of the largest pediatric liver transplant centers - showed that the number of transplant patients infected with Coronavirus disease 2019 (COVID- 19) increased progressively. However, they did not see greater severity and complications in this population. Immunosuppression could act as a protective factor. The present study aims to describe the prevalence of viral infection by SARS-CoV-2 in a sample of immunosuppressed children, from three groups: kidney transplants, liver transplants and oncohematological. The investigators will also look for the epidemiological profile and clinical evolution of these patients, enabling a better understanding of the COVID-19 in this special population. The investigators' hypothesis is that infection with the new coronavirus may be asymptomatic in a large number of children and that immunosuppression, observed in liver and kidney transplant patients and also seen in cancer patients, may act as protection for severe forms of COVID-19. After obtaining written informed consent from the family, the investigators will include patients from 0-18 years of age, on regular outpatient follow-up, symptomatic or not, and will check for the presence of IgM/IgG antibodies against the SARS-CoV-2. For those symptomatic or with a positive IgM result, material (oro/nasopharyngeal swabs) for RT-PCR trial for the new coronavirus will be collected. Demographic and clinical variables will be registered. The outcomes are: Serology for COVID-19 result; PCR for COVID-19 result; presence of symptoms of COVID-19; proportion of patients with viral shedding on days 3,7,14,21 and 30 after diagnosis; need for hospital admission; need for Intensive care admission; death.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2020

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

July 24, 2020

Last Update Submit

August 12, 2020

Conditions

Infections, CoronavirusKidney TransplantationLiver TransplantationCancerCovid19

Keywords

COVID-19Kidney transplantationLiver transplantationCancerChildrenAdolescentsPediatrics

Outcome Measures

Primary Outcomes (1)

  • Serology (IgM, IgG) for COVID-19.

    percentage of positivity

    9 months

Secondary Outcomes (6)

  • Hospital admission

    9 months

  • Intensive care admission

    9 months

  • Death

    9 months

  • Positive PCR for COVID-19

    9 months

  • Clinical characteristics of patients with COVID-19

    9 months

  • +1 more secondary outcomes

Study Arms (3)

Kidney transplant patients

Patients submitted to kidney transplantation.

Liver transplant patients

Patients submitted to liver transplantation.

Oncological patients

Oncological patients submitted to chemotherapy.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 0-18 years, immunosuppressed, kidney or liver transplanted, or oncologic patients, in outpatient follow-up or hospitalized.

You may qualify if:

  • Renal or liver transplant patients, with functioning graft and using immunosuppression, in outpatient follow-up or hospitalized.
  • Patients treating oncohematological disorders, in outpatient follow-up or hospitalized..

You may not qualify if:

  • Patients who or whose parents refuse to sign the Informed Consent Form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Federal de Bonsucesso

Rio de Janeiro, Rio de Janeiro, 21041030, Brazil

RECRUITING

Hospital Estadual da Criança

Rio de Janeiro, Rio de Janeiro, 21321230, Brazil

RECRUITING

Related Publications (9)

  • Danziger-Isakov L, Steinbach WJ, Paulsen G, Munoz FM, Sweet LR, Green M, Michaels MG, Englund JA, Murray A, Halasa N, Dulek DE, Madan RP, Herold BC, Fisher BT. A Multicenter Consortium to Define the Epidemiology and Outcomes of Pediatric Solid Organ Transplant Recipients With Inpatient Respiratory Virus Infection. J Pediatric Infect Dis Soc. 2019 Jul 1;8(3):197-204. doi: 10.1093/jpids/piy024.

    PMID: 29538674RESULT

  • Lee KH, Yoo SG, Cho Y, Kwon DE, La Y, Han SH, Kim MS, Choi JS, Kim SI, Kim YS, Min YH, Cheong JW, Kim JS, Song YG. Characteristics of community-acquired respiratory viruses infections except seasonal influenza in transplant recipients and non-transplant critically ill patients. J Microbiol Immunol Infect. 2021 Apr;54(2):253-260. doi: 10.1016/j.jmii.2019.05.007. Epub 2019 Jun 19.

    PMID: 31262511RESULT

  • 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: 32196933RESULT

  • Cortiula F, Pettke A, Bartoletti M, Puglisi F, Helleday T. Managing COVID-19 in the oncology clinic and avoiding the distraction effect. Ann Oncol. 2020 May;31(5):553-555. doi: 10.1016/j.annonc.2020.03.286. Epub 2020 Mar 19. No abstract available.

    PMID: 32201224RESULT

  • Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.

    PMID: 32172242RESULT

  • Memoli MJ, Athota R, Reed S, Czajkowski L, Bristol T, Proudfoot K, Hagey R, Voell J, Fiorentino C, Ademposi A, Shoham S, Taubenberger JK. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis. 2014 Jan;58(2):214-24. doi: 10.1093/cid/cit725. Epub 2013 Nov 1.

    PMID: 24186906RESULT

  • Fitzner J, Qasmieh S, Mounts AW, Alexander B, Besselaar T, Briand S, Brown C, Clark S, Dueger E, Gross D, Hauge S, Hirve S, Jorgensen P, Katz MA, Mafi A, Malik M, McCarron M, Meerhoff T, Mori Y, Mott J, Olivera MTDC, Ortiz JR, Palekar R, Rebelo-de-Andrade H, Soetens L, Yahaya AA, Zhang W, Vandemaele K. Revision of clinical case definitions: influenza-like illness and severe acute respiratory infection. Bull World Health Organ. 2018 Feb 1;96(2):122-128. doi: 10.2471/BLT.17.194514. Epub 2017 Nov 27.

    PMID: 29403115RESULT

  • Kumar D, Tellier R, Draker R, Levy G, Humar A. Severe Acute Respiratory Syndrome (SARS) in a liver transplant recipient and guidelines for donor SARS screening. Am J Transplant. 2003 Aug;3(8):977-81. doi: 10.1034/j.1600-6143.2003.00197.x.

    PMID: 12859532RESULT

  • 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: 32066541RESULT

MeSH Terms

Conditions

Coronavirus InfectionsNeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thais L Cleto-Yamane, MD, MSc

    D'Or Institute for Research and Education (IDOR)

    PRINCIPAL INVESTIGATOR

  • Arnaldo Prata-Barbosa, MD, PhD

    D'Or Institute for Research and Education (IDOR)

    STUDY DIRECTOR

  • Antonio José L A da Cunha, MD, PhD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR

Central Study Contacts

Thais L Cleto-Yamane, MD, MSc

CONTACT

5521988046852thaiscleto@yahoo.com.br

Arnaldo Prata-Barbosa, MD, PhD

CONTACT

5521999744098arnaldoprata@globo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

August 13, 2020

Study Start

June 30, 2020

Primary Completion

October 1, 2020

Study Completion

April 1, 2021

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations

BR(2)