Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04552340
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2020-09-08
Brief Title:
Epidemiologic Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Epidemiologic Clinical and Molecular Characteristics of Patients With Acute Respiratory Failure Affected by 2019-NCOV A Retrospective-Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2022-09
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:
The main purpose of this study is to identify possible predictor factor of mortality in patients affected by COVID-19 with respiratory failure needing oxygen therapy or ventilatory support In addiction the study aims to identify factors related to predisposition to SARS-CoV2 viral infection different symptoms response to therapy predisposition to complications related to the disease To this end the haemodynamic parameters and all imaging reports will be evaluated and clinical and laboratory tests as well as cellular and molecular analyzes will be performed in the analyzed patients In addition investigations will be carried out on the profile of the alveolar or nasal microbiota and if possible of the metabolic products and estimates on antibody titers
Detailed Description:
The study is a cohort study with retrospective-prospective data collection All the clinical data collected in the study are usually monitored in the clinical practice and no additional clinical exams will be required for the sole purpose of the study
Patients will be asked consent for the research use of blood and bronchial lavageresidual samples from nasopharyngeal swabs to perform cellular and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease These experiments will have no direct impact on the clinical management of patients It is impossible to detail now all the experiments that will be performed on stored samples It is possible to anticipate that samples could be used to analyze the immune response by studying immune cells and soluble mediators of the immune response Moreover samples will be used to extract nucleic acids to analyze gene expression profiles and DNA variations possibly related with disease susceptibility Part of the genetic studies could be conducted in other laboratories abroad ie the Institute of Clinical Molecular Biology of the Christian-Albrechts-University of Kiel and the Institute of Clinical Medicine of the University of Oslo as part of scientific collaborations In particular the investigators plan to study the expression levels of molecules known to mediated viral infection like the Angiotensin converting enzyme 2 ACE2 and the Transmembrane protease serine 2 enzyme TMPRSS2 Genetic variants in these genes and more in general in other genes in the genome could be related to susceptibility to the viral infection andor to the severity of the clinical course of the disease Therefore the investigators plan to compare the frequency of genetic variants potentially related with COVID-19 susceptibilityseverity in different subgroups of patients ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU The extension of the analyses that will be performed cant be anticipated as it depends also on the amount of funding that will be available to the study potentially the entire genome could be analyzed
Original sepsis and ARDS biomarkers developed at ICH eg PTX3 sIL-1R2 MSF will be used to address their prognostic potential in COVID-19 patients PBMC will be analyzed by FACS to investigate the immunophenotype and correlate it to the clinical outcome Original markers of leukocyte functional activation developed at ICH will be included in the analysis eg IL-1R8 IL-1R2 The residual BAL and rhinopharyngeal swab will be used for microbiota analysis metabolomics and cytokine measurement Plasma and salivasputum will be used also to test anti-SARS-Cov-2 antibodies IgM IgG and IgA and for microbiota analysis
In order to better describe the populations of COVID-19 patients treated at our hospital it is necessary to collect disease outcome data over a short medium and long-term follow-up process The investigators aim to understand how disease and intensive treatments affect the lives of recovering patients In particular the investigators want to explore the health-related quality of life the impact of the disease on a psychological level the residual cardio-respiratory functional capacity and muscle strength All the tests chosen are common use tests in the follow-up of critically ill patients in particular with acute respiratory distress syndrome
The health-related quality of the life will be measured with the validated international questionnaire EQ-5D-5L in its Italian validated form The questionnaire is attached and has been authorized for free non-commercial use by the EuroQuol consortium
As a screening tool to evaluate the presence of psychological symptoms such as anxiety and depression the Hospital Anxiety and Depression Scale HADS questionnaire will be administered in its Italian version
The cardio-respiratory functional capacity will be measured with the Six-Minutes Walk Test following the international guidelines published by the American Thoracic Society
The single breath count tets will be performed as well It consists in the ability to count from zero to twenty after a single maximum inspiration
Finally dynamic tests such as the Timed Up-and-Go TUG test and the Short physical performance battery SPPB test will be performed to evaluate muscle strength in particular of the lower limbs the ability to balance while walking and the general mobility of patients Both the aforementioned tests re internationally validated and are commonly used in the evaluation of the functional reserve of patients in the geriatric and rehabilitation setting All this tests can be administered to patients during their hospital stay or after their discharge at scheduled appointments
Patients will be asked consent for the research use of blood and bronchial lavageresidual samples from nasopharyngeal swabs to perform cellular and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease These experiments will have no direct impact on the clinical management of patients It is impossible to detail now all the experiments that will be performed on stored samples It is possible to anticipate that samples could be used to analyze the immune response by studying immune cells and soluble mediators of the immune response Moreover samples will be used to extract nucleic acids to analyze gene expression profiles and DNA variations possibly related with disease susceptibility Part of the genetic studies could be conducted in other laboratories abroad ie the Institute of Clinical Molecular Biology of the Christian-Albrechts-University of Kiel and the Institute of Clinical Medicine of the University of Oslo as part of scientific collaborations In particular the investigators plan to study the expression levels of molecules known to mediated viral infection like the Angiotensin converting enzyme 2 ACE2 and the Transmembrane protease serine 2 enzyme TMPRSS2 Genetic variants in these genes and more in general in other genes in the genome could be related to susceptibility to the viral infection andor to the severity of the clinical course of the disease Therefore the investigators plan to compare the frequency of genetic variants potentially related with COVID-19 susceptibilityseverity in different subgroups of patients ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICU The extension of the analyses that will be performed cant be anticipated as it depends also on the amount of funding that will be available to the study potentially the entire genome could be analyzed
Original sepsis and ARDS biomarkers developed at ICH eg PTX3 sIL-1R2 MSF will be used to address their prognostic potential in COVID-19 patients PBMC will be analyzed by FACS to investigate the immunophenotype and correlate it to the clinical outcome Original markers of leukocyte functional activation developed at ICH will be included in the analysis eg IL-1R8 IL-1R2 The residual BAL and rhinopharyngeal swab will be used for microbiota analysis metabolomics and cytokine measurement Plasma and salivasputum will be used also to test anti-SARS-Cov-2 antibodies IgM IgG and IgA and for microbiota analysis
In order to better describe the populations of COVID-19 patients treated at our hospital it is necessary to collect disease outcome data over a short medium and long-term follow-up process The investigators aim to understand how disease and intensive treatments affect the lives of recovering patients In particular the investigators want to explore the health-related quality of life the impact of the disease on a psychological level the residual cardio-respiratory functional capacity and muscle strength All the tests chosen are common use tests in the follow-up of critically ill patients in particular with acute respiratory distress syndrome
The health-related quality of the life will be measured with the validated international questionnaire EQ-5D-5L in its Italian validated form The questionnaire is attached and has been authorized for free non-commercial use by the EuroQuol consortium
As a screening tool to evaluate the presence of psychological symptoms such as anxiety and depression the Hospital Anxiety and Depression Scale HADS questionnaire will be administered in its Italian version
The cardio-respiratory functional capacity will be measured with the Six-Minutes Walk Test following the international guidelines published by the American Thoracic Society
The single breath count tets will be performed as well It consists in the ability to count from zero to twenty after a single maximum inspiration
Finally dynamic tests such as the Timed Up-and-Go TUG test and the Short physical performance battery SPPB test will be performed to evaluate muscle strength in particular of the lower limbs the ability to balance while walking and the general mobility of patients Both the aforementioned tests re internationally validated and are commonly used in the evaluation of the functional reserve of patients in the geriatric and rehabilitation setting All this tests can be administered to patients during their hospital stay or after their discharge at scheduled appointments
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