Name (Synonyms) | Correlation | |
---|---|---|
drug2481 | Tezepelumab Wiki | 0.26 |
drug1971 | Quantitative IgG Test Wiki | 0.26 |
drug967 | Fourth Trimester Mobile Tool Wiki | 0.26 |
drug1157 | ION-827359 Wiki | 0.26 |
drug1340 | Liberase Enzyme (Roche) Wiki | 0.26 |
drug1410 | MLS Laser Wiki | 0.26 |
drug2264 | Singing for Lung Health group attendance Wiki | 0.26 |
drug353 | Biological/Vaccine: Angiotensin peptide (1-7) derived plasma Wiki | 0.26 |
drug2055 | Regular Inpatient Medical Care Wiki | 0.26 |
drug75 | ARALAST NP Wiki | 0.26 |
drug1160 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.26 |
drug678 | Covid-19 Rapid Test Kit (RAPG-COV-019) Wiki | 0.26 |
drug1487 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.26 |
drug2277 | Snorkel-based improvised personal protective equipment Wiki | 0.26 |
drug567 | Chloroquine or hydroxychloroquine Wiki | 0.26 |
drug255 | Awake Prone Positioning Wiki | 0.26 |
drug762 | Diet tracking and survey Wiki | 0.26 |
drug2785 | conjunctival swab Wiki | 0.26 |
drug1950 | Pulmonary function tests Wiki | 0.26 |
drug2361 | Sterile Normal Saline for Intravenous Use Wiki | 0.26 |
drug505 | CYNK-001 Wiki | 0.26 |
drug537 | Centricyte 1000 Wiki | 0.26 |
drug2440 | Taking biological samples Wiki | 0.26 |
drug809 | EHR-based Clinician Jumpstart Wiki | 0.26 |
drug899 | Extra blood sample Wiki | 0.26 |
drug1175 | Imaging Wiki | 0.26 |
drug2241 | Serology for Covid-19 Wiki | 0.26 |
drug520 | Capillary and salivary sampling Wiki | 0.26 |
drug2441 | Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki | 0.18 |
drug33 | 2D Telemedicine Wiki | 0.18 |
drug386 | Blood sampling Wiki | 0.15 |
drug41 | 3D Telemedicine Wiki | 0.15 |
drug2314 | Standard care Wiki | 0.10 |
drug1822 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D008173 | Lung Diseases, Obstructive NIH | 0.43 |
D004646 | Emphysema NIH | 0.37 |
D017563 | Lung Diseases, Interstitial NIH | 0.33 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.27 |
D030341 | Nidovirales Infections NIH | 0.26 |
D029481 | Bronchitis, Chronic NIH | 0.26 |
D001991 | Bronchitis NIH | 0.26 |
D001982 | Bronchial Diseases NIH | 0.26 |
D006969 | Hypersensitivity, Immediate NIH | 0.26 |
D012130 | Respiratory Hypersensitivity NIH | 0.26 |
D001469 | Barotrauma NIH | 0.26 |
D011649 | Pulmonary Alveolar Proteinosis NIH | 0.26 |
D018410 | Pneumonia, Bacterial NIH | 0.26 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.26 |
D019896 | Alpha 1-Antitrypsin Deficiency NIH | 0.26 |
D011658 | Pulmonary Fibrosis NIH | 0.23 |
D007154 | Immune System Diseases NIH | 0.21 |
D001987 | Bronchiectasis NIH | 0.18 |
D014652 | Vascular Diseases NIH | 0.18 |
D016491 | Peripheral Vascular Diseases NIH | 0.18 |
D000208 | Acute Disease NIH | 0.18 |
D011024 | Pneumonia, Viral NIH | 0.16 |
D058729 | Peripheral Arterial Disease NIH | 0.15 |
D006967 | Hypersensitivity, NIH | 0.15 |
D009362 | Neoplasm Metastasis NIH | 0.15 |
D001249 | Asthma NIH | 0.13 |
D051437 | Renal Insufficiency, NIH | 0.13 |
D006331 | Heart Diseases NIH | 0.13 |
D008175 | Lung Neoplasms NIH | 0.13 |
D008103 | Liver Cirrhosis, NIH | 0.13 |
D003333 | Coronaviridae Infections NIH | 0.13 |
D012327 | RNA Virus Infections NIH | 0.13 |
D012140 | Respiratory Tract Diseases NIH | 0.12 |
D011665 | Pulmonary Valve Insufficiency NIH | 0.11 |
D007676 | Kidney Failure, Chronic NIH | 0.11 |
D007249 | Inflammation NIH | 0.10 |
D006333 | Heart Failure NIH | 0.10 |
D002908 | Chronic Disease NIH | 0.08 |
D011014 | Pneumonia NIH | 0.06 |
D009369 | Neoplasms, NIH | 0.06 |
D002318 | Cardiovascular Diseases NIH | 0.06 |
D012141 | Respiratory Tract Infections NIH | 0.05 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D003141 | Communicable Diseases NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.04 |
D014777 | Virus Diseases NIH | 0.03 |
D007239 | Infection NIH | 0.03 |
D013577 | Syndrome NIH | 0.03 |
D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.03 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002088 | Abnormal lung morphology HPO | 1.00 |
HP:0006536 | Pulmonary obstruction HPO | 0.43 |
HP:0006515 | Interstitial pneumonitis HPO | 0.33 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.27 |
HP:0012387 | Bronchitis HPO | 0.26 |
HP:0004469 | Chronic bronchitis HPO | 0.26 |
HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.26 |
HP:0002206 | Pulmonary fibrosis HPO | 0.23 |
HP:0002110 | Bronchiectasis HPO | 0.18 |
HP:0012393 | Allergy HPO | 0.15 |
HP:0002099 | Asthma HPO | 0.13 |
HP:0000083 | Renal insufficiency HPO | 0.13 |
HP:0001395 | Hepatic fibrosis HPO | 0.13 |
HP:0100526 | Neoplasm of the lung HPO | 0.13 |
HP:0004950 | Peripheral arterial stenosis HPO | 0.12 |
HP:0010444 | Pulmonary insufficiency HPO | 0.11 |
HP:0001635 | Congestive heart failure HPO | 0.10 |
HP:0002090 | Pneumonia HPO | 0.06 |
HP:0002664 | Neoplasm HPO | 0.06 |
HP:0011947 | Respiratory tract infection HPO | 0.05 |
HP:0001626 | Abnormality of the cardiovascular system HPO | 0.05 |
There are 15 clinical trials
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.
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.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.A randomised clinical trial to assess the impact of group singing on health for people with chronic obstructive pulmonary disease (COPD).
Description: A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability.
Measure: Change from Baseline in Short Form 36 tool (SF-36) Time: At baseline, then repeated after 12 weeks.Description: a disease specific health status measure. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst).
Measure: Changes in COPD assessment test (CAT) Time: At baseline, then repeated after 12 weeks.Description: Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety.
Measure: Changes in Generalised Anxiety Disorder Assessment (GAD-7) Time: At baseline, then repeated after 12 weeks.Description: Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression.
Measure: Changes in Patient Health Questionnaire 9 (PHQ-9) Time: At baseline, then repeated after 12 weeks.Description: Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea.
Measure: Changes in Dyspnoea-12 questionnaire Time: At baseline, then repeated after 12 weeks.Description: Distance walked in 6 minutes. Tests exercise capacity. To be performed in accordance with ATS/ERS guidelines including a practice walk.
Measure: Changes in Six-minute walk test Time: At baseline, then repeated after 12 weeks.Description: This involves a one week recall questionnaire and McRoberts MoveMonitor device physical activity monitor.
Measure: Changes in PROactive physical activity in COPD tool (cPPAC) Time: At baseline, then repeated after 12 weeks.Description: Balance confidence during activities of daily living, assessed using self-reported questionnaire. 16 item scale which gives a total balance confidence score of 0 to 100. Lower scores indicate less confidence.
Measure: Changes in Activities-specific Balance Confidence scale Time: At baseline, then repeated after 12 weeks.Description: Physical performance evaluated using the SPPB (instrumented with the McRoberts fixed-body sensor MoveTest device). Consists of 4 performance tasks (balance, walk speed and sit-to-stand) scored from 0 to 4, giving a total score out of 12 for SPPB.
Measure: Changes in Short Physical Performance Battery (SPPB) Time: At baseline, then repeated after 12 weeks.The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.
Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.
Measure: EHR documentation of Goals of Care discussions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU admissions Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/ICU use: ICU length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care/Hospital use: Hospital length of stay Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: Hospital Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.
Measure: Intensity of care: ICU Readmissions 30 days Time: Assessed for the period between randomization and 30 days following randomizationDescription: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.
Measure: Intensity of care: Healthcare costs Time: 1 and 3 months after randomizationDescription: From Washington State death certificates.
Measure: All-cause mortality at 1 year (safety outcome) Time: 1 year after randomizationDescription: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.
Measure: Key Implementation Factors Time: 3 months after randomizationIt has been reported that nearly half of the patients who are hospitalized for Covid-19 pneumonia have on admission old age or comorbidities. In particular, hypertension was present in 30% of the cases, diabetes in 19%, coronary heart disease in 8% and chronic obstructive lung disease in 3% of the patients. Amazingly, in the two major studies published in the Lancet (Zhou F et al Lancet 2020) and in the New England Journal of Medicine (Guan W et al 2020), the weight of the subjects as well their body mass index (BMI) were omitted. However, obesity, alone or in association with diabetes, can be a major predisposition factor for Covid-19 infection. The primary end-point of our prospective, observational study is to assess the recovery rate in patients with diagnosis of Covid-19 pneumonia. Among the other secondary end-points, we intend to find the predictors of the time to clinical improvement or hospital discharge in patients affected by Covid-19 pneumonia.
Description: mean rate of recovery in patients with diagnosis of Covid-19 pneumonia, who present with complications at the time of hospital admission (such as diabetes, obesity, cardiovascular disease, hypertension or respiratory failure), with the mean recovery rate in patients without any of the above-mentioned complications.
Measure: rate of recovery Time: 3 weeksDescription: comparison of the survival curves (times to improvement) in the two groups (patients with and without complications) and among patients presenting with different types of complications
Measure: time to improvement Time: 3 weeksDescription: the efficacy of different pharmaceutical treatment against Covid-19
Measure: efficacy of treatments Time: 3 weeksDescription: liver, kidney or multiorgan failure, cardiac failure
Measure: organ failure Time: 3 weeksCOVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measure: Pulmonary Function Analysis Time: baseline, 3 Month, 6 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsThe patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways. Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.
Description: Collection of conjunctival cell samples from eyes of COVID-19 patients. Analysis of conjunctival cells by real-time PCR to document presence of COVID-19. Binary outcome: yes, no. To evaluate the result in relation to nasopharyngeal swab (binary outcome yes, no) and to correlate conjunctival with nasopharyngeal swab positivity
Measure: Conjunctival swab results based on RT-PCR Time: 2 monthsDescription: To evaluate the agreement between conjunctival swab positivity and the degree of systemic impairment. The latter will be measured on the basis of pulmonary disease severity as assessed by a standardized scale (Occhipinti et al 2019) for interstitial lung involvement in systemic sclerosis; the blood measurements of d-dimer, LDH and reactive CP.
Measure: Conjunctival swab positivity in relation to Pulmonary and blood abnormalities Time: 2 monthsThis 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.
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 daysDescription: 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 daysMolecular testing (e.g PCR) of respiratory tract samples is the recommended method for the identification and laboratory confirmation of COVID-19 cases. Recent evidence reported that the diagnostic accuracy of many of the available RT-PCR tests for detecting SARS-CoV2 may be lower than optimal. Of course, the economical and clinical implications of diagnostic errors are of foremost significance and in case of infectious outbreaks, namely pandemics, the repercussions are amplified. False positives and false-negative results may jeopardize the health of a single patient and may affect the efficacy of containment of the outbreak and of public health policies. In particular, false-negative results contribute to the ongoing of the infection causing further spread of the virus within the community, masking also other potentially infected people.
Description: assess if inpatients who presented with pneumonia but had a negative test for Covid-19 are positive at the serology for SARS-CoV-2.
Measure: Serology Time: 3 weeksDescription: to find if the combination of CT scan and serology could help us in the identification of those patients who were initially negative at laboratory testing alone.
Measure: Efficacy of CT scan and Serology Time: 3 weeksDescription: the efficacy of different pharmaceutical treatments against Covid-19
Measure: Efficacy of different pharmaceutical treatments Time: 3 weeksThe aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.
Description: ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's
Measure: Patient Disposition Post treatment Time: 7 daysDescription: Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol
Measure: oxygenation Time: Daily for 4 daysDescription: The change in pre treatment levels and 24 hours post final treatment
Measure: IL-6 levels Time: First four days of trialDescription: Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale
Measure: Chest Xray radiographic results Time: 7 DaysDescription: The change in pretreatment and post treatment BCRSS will be evaluated
Measure: Brescia-COVID Respiratory Severity Scale Time: 7 daysDescription: The change in pretreatment and post treatment scores will be evaluated
Measure: SMART-COP Score Time: 7 daysDescription: The change in pretreatment and post treatment scores will be evaluated
Measure: PSI Score Time: 7 daysDescription: The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
Measure: CRP levels Time: 7 daysProne positioning is an established intervention in mechanically ventilated acute respiratory distress syndrome (ARDS) patients, with demonstrated reductions in mortality. Preliminary data suggest that awake proning in patients with COVID-19 treated with high-flow nasal oxygenation (HFNO) improves gas exchanges, and might be associated with a reduced need of mechanical ventilation, and reduced mortality. Further investigation in a formal randomized-controlled trial is need.
Description: Total time spent in prone position, as recorded by nursing or respiratory therapists
Measure: Time in prone position Time: Up to 28 days post randomizationDescription: Daily evolution of oxygenation
Measure: Oxygenation (SpO2/FiO2 ratio) Time: Until HFNC weaning, or up to 14 days after randomization, whichever is firstCOVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.The most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms. Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both. Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.
Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 1 month after discharge or diagnosis of COVID-19 disease by the use of HR-CT.
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month Time: 1 monthDescription: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 3 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months Time: 3 monthsDescription: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 6 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months Time: 6 monthsPneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
Description: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T1 at 6 months from dischargeDescription: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T2 at 12 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV,%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T1 at 6 months from dischargeDescription: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T2 at 12 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T1 at 6 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T2 at 12 months from dischargeDescription: Presence and extension of radiological alterations at chest X-ray
Measure: Presence and extension of radiological alterations at chest X-ray Time: T1 at 6 months from dischargeDescription: Presence and extension of radiological alterations at chest CT scan
Measure: Presence and extension of radiological alterations at chest CT scan Time: T2 at 12 months from dischargeThe purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.
Description: Annual rate of the physiologically adjusted lung density change will be measured as the 15th percentile of the lung density measurements (PD15) as assessed by Computed Tomography (CT) densitometry at total lung capacity (TLC). CT lung density at the 15th percentile (PD15) is the threshold below which 15 percentage (%) of the voxels have lower densities and is used as the parameter for estimating the rate of lung density decline. Annual rate of the physiologically adjusted lung density change will be tested in a fixed comparision sequence 1. ARALAST NP 120 mg/kg BW/week group versus (vs) external placebo group, 2. ARALAST NP120 mg/kg BW/week vs 60 mg/kg BW/week, 3. ARALAST NP 60 mg/kg BW/week group vs external placebo group.
Measure: Annual Rate of the Physiologically Adjusted Lung Density Change Time: Baseline, up to Week 104Description: COPD exacerbations are defined as an acute worsening of respiratory symptoms that results in additional therapy and will be assessed according to the classification in GOLD criteria (2020) as follows: Moderate (treated with short acting bronchodilators [SABDs] plus antibiotics and/or oral corticosteroids) and Severe (required hospitalizations or a visit to the emergency room).
Measure: Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Time: Baseline, up to Week 104Description: Annual rate of change in post-bronchodilator FEV1 will be assessed.
Measure: Annual Rate of Change in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Time: Baseline, up to Week 104Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. TEAE's will include related, serious adverse events (SAEs), suspected adverse reactions plus adverse reactions of interest, temporally-associated adverse events (AEs) with onset during infusion or within 24 hours following the end of IP infusion, and AEs resulting in changes to infusion dose.
Measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE's) Time: From Start of the study drug administration up to End of the study (up to Week 105)Description: Number of participants who develop anti- A1PI antibodies following treatment with ARALAST NP will be assessed.
Measure: Number of Participants Who Develop Anti-A1PI Antibodies Following Treatment With ARALAST NP Time: From Start of the study drug administration up to End of the study (up to Week 105)Description: Plasma trough level of antigenic and functional A1PI for ARALAST NP at each dose level (ARALAST NP 60 mg/kg BW/week, ARALAST NP 120 mg/kg BW/week) will be assessed.
Measure: Plasma Trough Level of Antigenic and Functional A1PI for ARALAST NP at each dose Level Time: Pre-dose, Weeks 4, 13, 28, 52, 78, 91, 104, 105The purpose of this study is to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in patients with mild to moderate COPD with CB.
Description: The EXACT (E-RS) scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with COPD. The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness, cough and sputum, and chest symptoms. The E-RS will be collected on the daily e-diary, which will include all 14 items from the EXACT questionnaire.
Measure: Change From Baseline in the EXACT Respiratory Symptoms (E-RS) Daily Symptom Diary to the Primary Time Point Time: One week prior to first dose through one week after the last dose.Description: The CAT is an eight-item questionnaire that will be completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. The CAT provides a score of 0-40 to indicate the impact of the disease.
Measure: Change From Baseline in the COPD Assessment Test (CAT) to the Week 14 Time Point Time: From Baseline up to Week 14Description: The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. Scores of the SGRQ-C range from 0 to 100, with higher scores indicating more limitations.
Measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) to the Week 14 Time Point Time: From Baseline up to Week 14By the end of 2019 a new coronavirus, named SARS-CoV-2, was discovered in patients with pneumonia in Wuhan, China. In the following weeks and months the virus spread globally, having a tremendous impact on global health and economy. To date, no vaccine or therapy is available. Severe courses of the infection not only affect the lungs, but also other organs like the heart, kidney, or liver. The lack of preexisting immunity might at least partially explain the affection of extra pulmonary organs not yet seen in infections due to other respiratory viruses. In this observational investigation the study group will follow up on patients that have been hospitalized due to a SARS-CoV-2 infection, and monitor sequelae in various organs, with an emphasis on the pulmo-cardiovascular system. Our that in some patients, organ damage will persist and require long-term medical care.
Description: Identify organ dysfunction after SARS-CoV-2 infections
Measure: Sequelae after COVID-19 Time: 12 months, extension if required