COVID-19 in Immunosuppressed Children

Cancer Clinical Trial

Official title:

COVID-19 in Immunosuppressed Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04511429
• Other study ID #: 062-2020
• Status: Recruiting
• Start date: June 30, 2020
• Est. completion date: April 2021

Study information

• Verified date: August 2020
• Source: D'Or Institute for Research and Education
• Contact: Thais L Cleto-Yamane, MD, MSc
• Phone: 5521988046852
• Email: thaiscleto[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Variables to be measured

• Demographic data (initials, record, age, sex, race / ethnicity, weight, height, BMI).

• Epidemiological data:

• For kidney transplant patients: time of transplant, in years and complete months; primary kidney disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.

• For liver transplant patients: time of transplant, in years and complete months; primary liver disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current immunosuppression (drugs and doses); serum level of calcineurin inhibitor on the day of collection; previous vaccination for Influenza; previous viral infections; date of the last episode of rejection treated.

• For oncohematological patients: time of diagnosis, in years and complete months; primary oncohematological disease; treatment received for the oncohematological disease; presence and time of onset of respiratory symptoms, in days; presence of risk factors or comorbidities; current cancer treatment; previous vaccination for Influenza; previous viral infections.

• Clinics visit / hospitalization data: clinical picture: syndromic diagnosis / signs and symptoms; initial image exam: chest X-ray and / or chest CT; Treatment performed: antiviral, antibiotic, corticoid (reason / dose / time); respiratory support (oxygen therapy only / Non-Invasive Ventilation / High Flow Nasal Cannula / invasive mechanical pulmonary ventilation / ECMO - time of use (days); days free of oxygen therapy, Non-Invasive Ventilation and invasive mechanical pulmonary ventilation.

• Diagnosis of SARS-CoV-2 infection: rapid test for Covid-19 in the blood: IgM / IgG; rapid test for COVID-19 in nasopharyngeal or tracheal secretion.

• Outcomes: 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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..

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cancer
• Coronavirus Infections
• Covid19
• Infections, Coronavirus
• Kidney Transplantation
• Liver Transplantation

Locations

Country	Name	City	State
Brazil	Hospital Estadual da Criança	Rio De Janeiro	RJ
Brazil	Hospital Federal de Bonsucesso	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Hospital Estadual da Criança, Hospital Federal de Bonsucesso, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. — View Citation

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 Trans — View Citation

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 — View Citation

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. — View Citation

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 c — View Citation

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. — View Citation

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 Infe — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serology (IgM, IgG) for COVID-19.	percentage of positivity	9 months
Secondary	Hospital admission	percentage of patients admitted to hospital	9 months
Secondary	Intensive care admission	percentage of patients admitted to intensive care unit	9 months
Secondary	Death	percentage of patients who died	9 months
Secondary	Positive PCR for COVID-19	percentage of positivity	9 months
Secondary	Clinical characteristics of patients with COVID-19	Percentage of patients with symptoms of COVID-19	9 months
Secondary	Proportion of patients with viral excretion in respiratory secretion and faeces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.	Percentage of patients with positive PCR in respiratory secretion and feces on days 3, 7, 14, 21 and 30 after confirmation of covid 19.	9 months