Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511429
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2020-07-24
Brief Title:
COVID-19 in Immunosuppressed Children
Sponsor:
DOr Institute for Research and Education
Organization:
DOr Institute for Research and Education
Study Overview
Official Title:
COVID-19 in Immunosuppressed Children
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 IgMIgG antibodies against the SARS-CoV-2 For those symptomatic or with a positive IgM result material oronasopharyngeal 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 371421 and 30 after diagnosis need for hospital admission need for Intensive care admission death
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 IgMIgG antibodies against the SARS-CoV-2 For those symptomatic or with a positive IgM result material oronasopharyngeal 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 371421 and 30 after diagnosis need for hospital admission need for Intensive care admission death
Detailed 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 371421 and 30 after diagnosis need for hospital admission need for Intensive care admission death
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 371421 and 30 after diagnosis need for hospital admission need for Intensive care admission death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None