Covid 19 Research using Clinical Trials (Home Page)
Report for D007154: Immune System Diseases NIH
(Synonyms: Immune Sy, Immune System Disease, Immune System Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2481 | Tezepelumab Wiki | 0.41 |
| drug886 | Exercise training group Wiki | 0.41 |
| drug787 | Dornase Alfa Inhalation Solution Wiki | 0.41 |
| drug389 | Blood tests sputum, nasal lavage and brushing Wiki | 0.41 |
| drug505 | CYNK-001 Wiki | 0.41 |
| drug899 | Extra blood sample Wiki | 0.41 |
| drug520 | Capillary and salivary sampling Wiki | 0.41 |
| drug2441 | Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki | 0.29 |
| drug1822 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (25)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D030341 | Nidovirales Infections NIH | 0.41 |
| D001982 | Bronchial Diseases NIH | 0.41 |
| D006969 | Hypersensitivity, Immediate NIH | 0.41 |
| D012130 | Respiratory Hypersensitivity NIH | 0.41 |
| D006453 | Hemoglobinopathies NIH | 0.41 |
| D051436 | Renal Insufficiency, Chronic NIH | 0.24 |
| D006967 | Hypersensitivity, NIH | 0.24 |
| D008171 | Lung Diseases, NIH | 0.21 |
| D001249 | Asthma NIH | 0.20 |
| D003333 | Coronaviridae Infections NIH | 0.20 |
| D012327 | RNA Virus Infections NIH | 0.20 |
| D012140 | Respiratory Tract Diseases NIH | 0.19 |
| D007674 | Kidney Diseases NIH | 0.18 |
| D008173 | Lung Diseases, Obstructive NIH | 0.14 |
| D002908 | Chronic Disease NIH | 0.13 |
| D012141 | Respiratory Tract Infections NIH | 0.09 |
| D007249 | Inflammation NIH | 0.08 |
| D011024 | Pneumonia, Viral NIH | 0.05 |
| D014777 | Virus Diseases NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D011014 | Pneumonia NIH | 0.02 |
| D007239 | Infection NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
Correlated HPO Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012393 | Allergy HPO | 0.24 |
| HP:0012622 | Chronic kidney disease HPO | 0.24 |
| HP:0002088 | Abnormal lung morphology HPO | 0.21 |
| HP:0002099 | Asthma HPO | 0.20 |
| HP:0000077 | Abnormality of the kidney HPO | 0.18 |
| HP:0006536 | Pulmonary obstruction HPO | 0.14 |
| HP:0011947 | Respiratory tract infection HPO | 0.09 |
| HP:0002090 | Pneumonia HPO | 0.02 |
There are 6 clinical trials
Clinical Trials
1 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
NCT03688074 Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Biological: Tezepelumab Other: Placebo MeSH:Asthma Lung Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Inflammation Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
2 A Phase I/II Study of Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (CYNK-001) for the Treatment of Adults With COVID-19
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in hospitalized patients with moderate COVID-19 disease.
NCT04365101 Coronavirus Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 Pneumonia Pneumonia, Viral Lung Diseases Respiratory Tract Disease Respiratory Tract Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Disease Immunologic Disease ARDS Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-infective Agents Analgesics Antimetabolites, Antineoplastic Biological: CYNK-001 MeSH:Infection Communicable Dis Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome RNA Virus Infections Pneumonia, Viral Coronaviridae Infections Nidovirales Infections Pneumonia Lung Diseases Virus Diseases Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Pneumonia Respiratory tract infection
Primary Outcomes
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 months
Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 12 months
Description: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 12 months
Description: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 days
Description: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 days
Secondary Outcomes
Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 months
Description: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 months
Description: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 months
Description: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 months
Description: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 months
Description: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 days
Description: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 days
Description: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 days
Description: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 days
3 Whole Blood Immune Cells Characterization in Critically Ill COVID-19 Patients: A Prospective Study
Primary Outcomes
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 12 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 12 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR in nasal and/or lower respiratory tract samples. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysSecondary Outcomes
Description: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 12 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 12 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 12 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 12 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 12 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysSARS-CoV-2 outbreak causes a spectrum of clinical patterns that varies from asymptomatic infection to mildly symptomatic manifestations and more-severe forms that need intensive care. Until now, the immune response to SARS-CoV-2 virus infection has been poorly reported to help decision for immune modulation therapies. As a consequence, trials have been designed to test both anti-inflammatory molecules as steroids or anti-bodies against IL-6, and others proposing to "boost" immunity with interferon beta based on similar inclusion criteria. The immune response to infective agents including viruses may have a complex time evolution with early and late phases corresponding to different patterns, oscillating between pro-inflammation and immune-depression. The potential window to improve outcome in COVID-19 by therapeutic intervention aimed at a fine tuning between immune toxicity and immunodepression requires a longitudinal assessment during the course of illness, especially for the patients who develop acute respiratory failure. Immune monitoring of both innate and adaptive immunity would then be essential to appropriately design clinical trials. The whole blood cells evaluation was recorded according to the time intervals between the onset of symptoms and the sampling after ICU admission. Patients' care was standardized, especially with regard to ventilation, sedation, and antimicrobial treatment. In this study the investigators prospectively perform a longitudinal study of both innate and adaptive immunity on patients admitted to ICU for an COVID-19 related acute respiratory failure. The data will be analyzed in reference to the onset of initial symptoms and also to the admission in ICU. The primary end point is the evolution of the characterization of monocytes and their subsets in term of number and expression of HLA-DR. A similar approach is used for lymphocytes and their subtypes with in addition, an ex vivo testing of their capabilities to be stimulated by SARS-CoV-2 viral proteins in term of TNFalpha, INFgamma, and IL1beta production. The secondary end-point was to test the association with outcomes and other non-specific markers of inflammation as CRP (C reactive protein), PCT (procalcitonin), DDimers and ferritin.
NCT04386395 SARS-CoV-2 Immune System Disorder MeSH:Immune System Diseases
Primary Outcomes
Description: circulating immune cell characterization
Measure: Changes in monocytes HLA-DR expression Time: through ICU stay, an average of 30 daysDescription: circulating immune cell characterization
Measure: Changes in lymphocytes subpopulations numbers Time: through ICU stay, an average of 30 daysDescription: circulating immune cell characterization
Measure: Changes in monocytes number Time: through ICU stay, an average of 30 daysSecondary Outcomes
Description: stimulation by SARS-CoV-2 viral proteins
Measure: TNFalpha level Time: 4 hoursDescription: stimulation by SARS-CoV-2 viral proteins
Measure: INFgamma level Time: 4 hoursDescription: stimulation by SARS-CoV-2 viral proteins
Measure: IL1beta level Time: 4 hoursDescription: Sequential Organ dysfunction assessement, ranging from 0 (better) to 24 (worst) outcome
Measure: SOFA score Time: through ICU stay, an average of 30 daysDescription: mortality
Measure: number of recorded deaths Time: through study completion, an average of 6 monthsDescription: infectious complications
Measure: presence of pneumonia Time: through ICU stay, an average of 30 daysDescription: infectious complications
Measure: presence of bacteremia Time: through ICU stay, an average of 30 daysDescription: infectious complications
Measure: presence of urinary tract infection Time: through ICU stay, an average of 30 daysDescription: inflammation marker
Measure: C reactive protein Time: through ICU stay, an average of 30 daysDescription: inflammation marker
Measure: D Dimers Time: through ICU stay, an average of 30 days4 PROSAIC-19 - Prospective Longitudinal Assessment in a COVID-19 Infected Cohort
DESIGN Longitudinal prospective observational multicentre study. Primary objective: Understand the immune mechanisms driving COVID-19 disease in patients with a history of lung disease
NCT04444609 COVID-19 SARS-CoV 2 ARDS, Human Immune System Disorder Other: Blood tests sputum, nasal lavage and brushing MeSH:Respiratory Distress Syndrome, Adult Immune System Diseases
Primary Outcomes
Description: Anti-viral cytokine protein concentration in blood samples by ELISA
Measure: Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Inflammatory cytokine protein concentration in sputum samples by ELISA
Measure: Anti-viral cytokines profiles within sputum samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Inflammatory cytokine protein concentration in nasal lavage samples by ELISA
Measure: Anti-viral cytokine profiles within nasal lavage samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Inflammatory gene expression in upper airway respiratory epithelial cells by RNA sequencing.
Measure: Expression of inflammatory gene expression in upper respiratory epithelial airway cells using nasal brush specimens in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearSecondary Outcomes
Description: Analysis of viral components recognized by the adaptive immune system
Measure: Identify the T cell antigens and B cell epitopes in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Cytokine protein concentration following PBMC stimulation to pathogen recognition receptor agonists by Elispot
Measure: Peripheral blood mononuclear cell (PBMC) interferon mediated immune responses to pathogen recognition receptor agonists in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Analysis of endothelial function
Measure: Identify endothelial function in chronic respiratory disease associated with susceptibility to severe COVID-19 infection using EndoPAT testing Time: Through study completion an average of 1 yearDescription: Serum and plasma protein concentration of endothelial cell inflammation biomarkers by ELISA
Measure: Endothelial cell inflammation biomarkers in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Analysis of sputum microbiome
Measure: Identify sputum 16S rRNA and ITS sequences in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Analysis of nasal microbiome
Measure: Identify nasal lavage 16S rRNA and ITS sequences in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 yearDescription: Study participant survey
Measure: Identify quality of life markers in chronic respiratory disease associated with susceptibility to severe COVID-19 infection Time: Through study completion an average of 1 year5 Retrospective and Prospective Database of COVID-19 Prevalence and Clinical Course in Pediatric and Young Adult Hematology/ Oncology/Stem Cell Therapy Patients in the New York Tri-State Area.
New York City (NYC) has become the epicenter of the worldwide pandemic caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). By collecting and summarizing the experience with other major health care providers in the tristate (New York (NY), New Jersey (NJ) and Connecticut (CT)) are, the investigators are uniquely positioned to inform the rest of the country about what to expect and how to manage children and young adults with hematological, oncological or stem cell transplant diagnoses during the pandemic.
NCT04445402 Pediatric Cancer Immune System Disorder COVID-19 Hemoglobinopathies MeSH:Hemoglobinopathies Immune System Diseases
Primary Outcomes
Description: To measure the success of the data registry in how many patients agreed to participate and completed the one year follow up. A confirmed case of COVID-19 is defined as a positive result on a reverse-transcriptase- polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab, or a serum antibody test. Only laboratory-confirmed cases will be described as positive.
Measure: Number of tristate area pediatric HOT patients tested for COVID-19 that completed 1 year follow-up Time: One yearSecondary Outcomes
Description: To analyze effect of COVID-19 on patients and their families mental health. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.
Measure: Change in PROMIS T-score Time: Baseline, 3 Months, 6 MonthsDescription: To examine if the pandemic has effects on the patients' nutrition and microbiome. Each patient is given an opportunity to provide stool samples in addition to survey response.
Measure: Number of collected and analyzed stool samples Time: Up to one year6 Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial
Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.
NCT04458246 Chronic Disease Chronic Diseases in Adolescence Chronic Disease of Immune System Chronic Kidney Diseases Other: Exercise training group MeSH:Kidney Diseases Renal Insufficiency, Chronic Chronic Disease Immune System Diseases
HPO:Abnormality of the kidney Chronic kidney disease Nephropathy
Primary Outcomes
Description: Semi structured interview
Measure: Safety and efficacy of a home-based exercise training program Time: From baseline to 3 months of follow-up
Secondary Outcomes
Description: Semi structured interview
Measure: Patients perceptions during social isolation Time: From baseline to 3 months of follow-up
Description: Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Measure: Adolescents quality of life Time: From baseline to 3 months of follow-up
Description: Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Measure: Disease activity Time: From baseline to 3 months of follow-up
Description: Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Measure: Disease overall assessment Time: From baseline to 3 months of follow-up
Description: Will be assessed by means of Strengths & Difficulties Questionnaires
Measure: Strengths and difficulties Time: From baseline to 3 months of follow-up
HPO Nodes
Primary Outcomes
Description: Semi structured interview
Measure: Safety and efficacy of a home-based exercise training program Time: From baseline to 3 months of follow-upSecondary Outcomes
Description: Semi structured interview
Measure: Patients perceptions during social isolation Time: From baseline to 3 months of follow-upDescription: Quality of life will be assessed by means of Pediatric Quality of Life inventory (PedsQLTM 4.0)
Measure: Adolescents quality of life Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of a visual analog scale (from 0 - no disease activity) to 10 - maximum disease activity).
Measure: Disease activity Time: From baseline to 3 months of follow-upDescription: Will be assessed using the visual analog scale from 0 (very good condition) to 10 (very poor condition).
Measure: Disease overall assessment Time: From baseline to 3 months of follow-upDescription: Will be assessed by means of Strengths & Difficulties Questionnaires
Measure: Strengths and difficulties Time: From baseline to 3 months of follow-up