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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3968 | Tezepelumab Wiki | 0.29 |
| drug3152 | Pulmonary function tests Wiki | 0.20 |
| drug2370 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.20 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug709 | CLBS119 Wiki | 0.20 |
| drug1329 | EarSats Pulse Oximeter Probe Wiki | 0.20 |
| drug289 | Angiography scanner Wiki | 0.20 |
| drug3214 | RAPA-501-Allo off-the-shelf Therapy of COVID-19 Wiki | 0.20 |
| drug1871 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.20 |
| drug413 | Awake Prone Positioning Wiki | 0.20 |
| drug3781 | Sterile Normal Saline for Intravenous Use Wiki | 0.20 |
| drug871 | Centricyte 1000 Wiki | 0.20 |
| drug1867 | ION-827359 Wiki | 0.20 |
| drug919 | Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument Wiki | 0.20 |
| drug1305 | EHR-based Clinician Jumpstart Wiki | 0.20 |
| drug4333 | Zavegepant (BHV-3500) Wiki | 0.20 |
| drug2127 | Liberase Enzyme (Roche) Wiki | 0.20 |
| drug1891 | Imaging Wiki | 0.20 |
| drug2549 | Nintedanib Wiki | 0.20 |
| drug4439 | consultation Wiki | 0.20 |
| drug816 | CYNK-001 Wiki | 0.20 |
| drug794 | CPI-006 Wiki | 0.20 |
| drug1517 | Favipiravir + Standard of Care Wiki | 0.20 |
| drug4438 | conjunctival swab Wiki | 0.20 |
| drug120 | ARALAST NP Wiki | 0.20 |
| drug3914 | Tele-Pulmonary rehabilitation Wiki | 0.20 |
| drug3307 | Regular Inpatient Medical Care Wiki | 0.20 |
| drug3629 | Singing for Lung Health group attendance Wiki | 0.20 |
| drug2241 | MLS Laser Wiki | 0.20 |
| drug3472 | SELF-BREATHE Wiki | 0.20 |
| drug1118 | CytoSorb 300 mL device Wiki | 0.20 |
| drug3594 | Serology for Covid-19 Wiki | 0.20 |
| drug53 | 2D Telemedicine Wiki | 0.14 |
| drug1406 | Ensifentrine Wiki | 0.14 |
| drug2935 | Placebo Comparator Wiki | 0.14 |
| drug470 | BIIB091 Wiki | 0.14 |
| drug1459 | Exposure Wiki | 0.14 |
| drug3252 | Rabeprazole Wiki | 0.14 |
| drug502 | Bacille Calmette-Guérin (BCG) Wiki | 0.14 |
| drug62 | 3D Telemedicine Wiki | 0.12 |
| drug3618 | Siltuximab Wiki | 0.12 |
| drug468 | BI 764198 Wiki | 0.12 |
| drug2028 | Itraconazole Wiki | 0.12 |
| drug2296 | Matching placebo Wiki | 0.10 |
| drug2616 | Normal Saline Wiki | 0.08 |
| drug614 | Blood sampling Wiki | 0.08 |
| drug3719 | Standard care Wiki | 0.07 |
| drug3728 | Standard of Care Wiki | 0.06 |
| drug2916 | Placebo Wiki | 0.06 |
| drug1047 | Convalescent Plasma Wiki | 0.04 |
| drug421 | Azithromycin Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D017563 | Lung Diseases, Interstitial NIH | 0.38 |
| D008173 | Lung Diseases, Obstructive NIH | 0.38 |
| D004646 | Emphysema NIH | 0.29 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.26 |
| D000542 | Alveolitis, Extrinsic Allergic NIH | 0.20 |
| D029481 | Bronchitis, Chronic NIH | 0.20 |
| D001991 | Bronchitis NIH | 0.20 |
| D001982 | Bronchial Diseases NIH | 0.20 |
| D006969 | Hypersensitivity, Immediate NIH | 0.20 |
| D012130 | Respiratory Hypersensitivity NIH | 0.20 |
| D001469 | Barotrauma NIH | 0.20 |
| D011649 | Pulmonary Alveolar Proteinosis NIH | 0.20 |
| D018410 | Pneumonia, Bacterial NIH | 0.20 |
| D001987 | Bronchiectasis NIH | 0.18 |
| D006967 | Hypersensitivity, NIH | 0.18 |
| D007154 | Immune System Diseases NIH | 0.17 |
| D011658 | Pulmonary Fibrosis NIH | 0.16 |
| D012140 | Respiratory Tract Diseases NIH | 0.16 |
| D030341 | Nidovirales Infections NIH | 0.14 |
| D000208 | Acute Disease NIH | 0.14 |
| D017093 | Liver Failure NIH | 0.14 |
| D019896 | Alpha 1-Antitrypsin Deficiency NIH | 0.14 |
| D011024 | Pneumonia, Viral NIH | 0.14 |
| D016491 | Peripheral Vascular Diseases NIH | 0.12 |
| D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.12 |
| D058729 | Peripheral Arterial Disease NIH | 0.10 |
| D000755 | Anemia, Sickle Cell NIH | 0.10 |
| D014652 | Vascular Diseases NIH | 0.10 |
| D008103 | Liver Cirrhosis, NIH | 0.10 |
| D009362 | Neoplasm Metastasis NIH | 0.09 |
| D003333 | Coronaviridae Infections NIH | 0.09 |
| D051437 | Renal Insufficiency, NIH | 0.08 |
| D012327 | RNA Virus Infections NIH | 0.08 |
| D007676 | Kidney Failure, Chronic NIH | 0.08 |
| D007249 | Inflammation NIH | 0.07 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.07 |
| D003550 | Cystic Fibrosis NIH | 0.07 |
| D012141 | Respiratory Tract Infections NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.06 |
| D004417 | Dyspnea NIH | 0.06 |
| D006333 | Heart Failure NIH | 0.06 |
| D008175 | Lung Neoplasms NIH | 0.06 |
| D001249 | Asthma NIH | 0.06 |
| D006331 | Heart Diseases NIH | 0.05 |
| D002908 | Chronic Disease NIH | 0.05 |
| D011655 | Pulmonary Embolism NIH | 0.05 |
| D005355 | Fibrosis NIH | 0.05 |
| D004617 | Embolism NIH | 0.05 |
| D012120 | Respiration Disorders NIH | 0.05 |
| D002318 | Cardiovascular Diseases NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.03 |
| D009369 | Neoplasms, NIH | 0.03 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
| D003141 | Communicable Diseases NIH | 0.03 |
| D018352 | Coronavirus Infections NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.02 |
| D007239 | Infection NIH | 0.02 |
| D013577 | Syndrome NIH | 0.02 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002088 | Abnormal lung morphology HPO | 1.00 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.38 |
| HP:0006536 | Pulmonary obstruction HPO | 0.38 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.26 |
| HP:0012387 | Bronchitis HPO | 0.20 |
| HP:0006516 | Hypersensitivity pneumonitis HPO | 0.20 |
| HP:0004469 | Chronic bronchitis HPO | 0.20 |
| HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.20 |
| HP:0012393 | Allergy HPO | 0.18 |
| HP:0002110 | Bronchiectasis HPO | 0.18 |
| HP:0002206 | Pulmonary fibrosis HPO | 0.16 |
| HP:0001399 | Hepatic failure HPO | 0.14 |
| HP:0001395 | Hepatic fibrosis HPO | 0.10 |
| HP:0000083 | Renal insufficiency HPO | 0.08 |
| HP:0004950 | Peripheral arterial stenosis HPO | 0.08 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.07 |
| HP:0011947 | Respiratory tract infection HPO | 0.07 |
| HP:0002090 | Pneumonia HPO | 0.06 |
| HP:0002098 | Respiratory distress HPO | 0.06 |
| HP:0001635 | Congestive heart failure HPO | 0.06 |
| HP:0100526 | Neoplasm of the lung HPO | 0.06 |
| HP:0002099 | Asthma HPO | 0.06 |
| HP:0002204 | Pulmonary embolism HPO | 0.05 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.04 |
| HP:0002664 | Neoplasm HPO | 0.03 |
Navigate: Correlations HPO
There are 24 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.A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Description: The exacerbation rate is based on exacerbations reported by the investigator over 52 weeks.
Measure: Moderate or severe COPD exacerbation rate ratio (tezepelumab vs placebo) Time: Over 52 WeeksDescription: Time to first occurrence of moderate/severe exacerbation post randomization. Outcome measures: Hazard ratio
Measure: Time to first moderate or severe COPD exacerbation Time: By Week 52Description: Proportion of subjects with at least one moderate/severe exacerbation reported by the Investigator over 52 weeks Outcome measure: Odds Ratio
Measure: Proportion with at least one moderate/severe COPD exacerbation Time: Over 52 WeeksDescription: The severe exacerbation rate is based on severe exacerbations reported by the Investigator over 52 weeks.
Measure: Severe COPD exacerbation rate ratio (tezepelumab vs. placebo) Time: Over 52 WeeksDescription: Difference in change from baseline in pre-BD forced expiratory volume in 1 second (FEV1) in tezepelumab arm as compared to placebo at Week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of forced expiration.
Measure: Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) Time: Baseline, Week 52Description: Proportion of subjects achieving a decrease of 4 units or more in the St. George's Respiratory Questionnaire (SGRQ) total score at Week 52, i.e. minimum clinically important difference (MCID). Outcome measure: odds ratio
Measure: Change in respiratory health status/health-related quality of life Time: Baseline, Week 52Description: Difference (tezepelumab vs. placebo) in SGRQ from baseline at Week 52. SGRQ is a 50-item patient reported outcome questionnaire. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0% indicates the best possible health status. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment. Decrease of 4 units is associated with a minimum clinically important difference (MCID).
Measure: Change from baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score Time: Baseline, Week 52Description: Difference (tezepelumab vs. placebo) in COPD assessment tool (CAT) from baseline at Week 52. CAT is an 8-item patient reported outcome questionnaire developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. The score ranges from 0 to 40, with higher scores indicating greater COPD impact on health status.
Measure: Change from baseline in the COPD Assessment Test (CAT) Total Score Time: Baseline, Week 52Description: Serum trough concentration of tezepelumab
Measure: Evaluate pharmacokinetics of tezepelumab Time: Weeks 0, 4, 12, 24, 36, 52, 64Description: Incidence of anti-drug antibodies (ADA)
Measure: Evaluate immunogenicity of tezepelumab Time: Over 52 weeksThe objective of this study is to administer and validate a disease specific health related quality of life (HRQOL) survey for patients with Chronic Hypersensitivity Pneumonitis (CHP).
Description: The newly developed survey that is being validated consists of 42 items that assess the impact that Hypersensitivity Pneumonitis has on daily life for those who have the disease.
Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis Time: Day 0Description: This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 12 items. The average score for this survey has been calibrated to 50 with scores below 50 indicating a below average score and scores above 50 indicating an above average score.
Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the Short Form (SF-12) Survey Time: Day 0Description: This survey will be used to assess the validity of the newly developed health-related quality of life instrument. This survey consists of 15 items and is scored from 0-100 with 100 indicating good health.
Measure: Validation of a health-related quality of life instrument for patients with Chronic Hypersensitivity Pneumonitis by administering the King's Brief Interstitial Lung Disease Questionnaire Time: Day 0Description: The newly developed survey will be administered again in 2 weeks following the first assessment.
Measure: Change in Health-related Quality of Life Assessment Score Time: 2 weeks following Day 0The 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 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 6 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 6 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 6 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. 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 6 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 6 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 6 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 6 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 6 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 requiredThe current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die. The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients. To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause. The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
Description: Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
Measure: Rate of patients with pulmonary embolism Time: up to Day 12Description: Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Prothrombin level measurement Time: up to Day 12Description: Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: activated partial thromboplastin time measurement Time: up to Day 12Description: Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Fibrinogen measurement Time: up to Day 12Description: Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: D-dimers measurement Time: up to Day 12Description: Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Protein C measurement Time: up to Day 12Description: Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Willebrand antigen measurement Time: up to Day 12Description: Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Soluble tissue factor measurement Time: up to Day 12Description: Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Soluble thrombomodulin measurement Time: up to Day 12Description: Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: E-selectin measurement Time: up to Day 12Description: Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Thrombin-antithrombin complex measurement Time: up to Day 12Description: Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of clot formation curve Time: Day 1Description: Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of thrombin generation Time: Day 1Description: Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of fibrinolysis Time: Day 1Description: Determine patient mortality
Measure: Mortality Time: Day 30Since initial reports of a novel coronavirus emerged from Hubei province, China, the world has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by 30th April 2020. Health care systems around the world have struggled to cope with the number of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus). Although the majority of people infected with the virus have a mild disease, around 20% experience a more severe illness leading to hospital admission and sometimes require treatment in intensive care. People that survive severe COVID-19 are likely to have persistent health problems that would benefit from rehabilitation. Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improve physical and social performance and is typically provided for people with chronic lung conditions. PR courses typically last 6-12 weeks with patients attending classes once or twice weekly and consist of exercise and education components. PR is known to improve symptoms (e.g. breathlessness), quality of life and ability to exercise in those with lung conditions. Breathlessness is a very common symptom reported by people presenting to hospital with COVID-19 and loss of physical fitness will be very common. Using existing pulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitation programme (a programme that will be delivered using video link to overcome the challenges faced by social distancing and shielding advice) for people that have been critically ill with COVID-19. In order to prove whether people benefit from this tele-rehabilitation programme after being admitted to hospital following COVID-19 we would need to perform a large clinical trial. However, before doing this it is important for us to answer some key questions: - How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital? - Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge? - Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist? - Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.
Description: The proportion of the total patients contacted, that meet the intieligibility criteria and give consent to take part Data quality: completion of clinical outcomes (questionnaires and other assessments) at each time point and patterns of missing data for the study measures. Intervention: Adherence in delivery and uptake documented in the clinical record.
Measure: Recruitment - contact to consent ratio Time: through study completion an average of a yearDescription: The proportion of patients consented to the study that do not meet the eligibility criteria
Measure: Recruitment - screen failure rate Time: through study completion an average of a yearDescription: The number patients recruited over the designated time frame
Measure: Recruitment rate Time: through study completion an average of a yearDescription: The proportion of consented patients that complete the study
Measure: Recruitment retention Time: through study completion an average of 16 monthsDescription: The Modified Medical Research Council Dyspnoea Scale is a self rating tool to measure the degree of disability that breathlessness poses on day to day activities on a scale of 0-4; the higher the score the worse the outcome. A comparison of Change in MMRC dyspnoea scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group.
Measure: The Modified Medical Research Council (MMRC) Dyspnoea Scale Time: 8 weeksDescription: The Numerical Rating Scale is a self rating tool to measure breathlessness on a 0-10 scale; a higher number indicates a worse outcome. A comparison of change in numerical scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group
Measure: Numerical Rating Scale (NRS) of breathlessness Time: 8 weeksDescription: The Cough Visual Analogue Scale is a self rating assessment of cough on an 0-100mm scale: the higher the number reported the worse the symptom. A comparison of Change in cough visual analogue scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group
Measure: Cough Visual analogue Scale (VAS) Time: 8 weeksDescription: The EQ-5D-5L questionnaire assesses the patients current health status and consists of two elements: 1. Visual Analogue Scale with a range of 0-100mm- the higher the number the worse the outcome 2. A quality of life questionnaire split into 5 domains which generates a 5 digit code ranging from 11111 to 55555 with the higher number indicating a worse outcome. A comparison of Change in EQ-5D-5L quality of life questionnaire from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group
Measure: EQ-5D-5L questionnaire Time: 8 weeksDescription: The Hospital Anxiety and Depression scale consists of two sub scales anxiety and depression with a range of between 0-21, the higher score indicating the worse outcome. A comparison of Change in Hospital anxiety and depression questionnaire from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group
Measure: Hospital Anxiety and Depression scale Time: 8 weeksDescription: comparison of sit to stand test from baseline to post 8 weeks tele rehab within the group and between fast track and wait list grou
Measure: Sit to stand test Time: 8 weeksTITLE EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up DESIGN Non-inferiority study AIMS To evaluate qualitative and quantitative performance of in-ear SpO2 monitoring against the gold standard right finger-clip pulse oximeter -- towards validation for use in COVID-19 in the acute ambulatory and long-term monitoring setting OUTCOME MEASURES In-ear SpO2 compared with gold-standard finger-clip pulse oximeter: Correlation between SpO2 measurements at rest Correlation between SpO2 measurements during 6 minute walk test Signal quality during 6 minute walk test Qualitative evaluation of clinical and patient user acceptability using questionnaires POPULATION 30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations ELIGIBILITY Aged 18 and above, no upper age limit Able to give informed consent No abnormal ear anatomy. DURATION 12 months
Description: Mean error and root mean square error; measurements for statistical significance using a paired t-test.
Measure: In-Ear vs finger SpO2 Time: 12 months for full participant recruitment (actual head-to head comparison takes 1 minute for baseline reading and 6 minutes for 6-min walk test per patient)The purpose of this study is to determine if ensifentrine is safe and effective for the treatment of patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
Description: Change from baseline of Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h
Measure: Average forced expiratory volume in 1 second (FEV1) area under the curve (AUC)0-12h Time: 12 weeksDescription: Change from baseline of Average FEV1 AUC0-4h post-dose at Week 12
Measure: Average FEV1 AUC0-4h post-dose at Week 12 Time: 12 weeksDescription: Change from baseline of Peak FEV1 over 4 hours post-dose at Week 12
Measure: Peak FEV1 over 4 hours post-dose at Week 12 Time: 12 weeksDescription: Change from baseline as a weekly average of Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24
Measure: Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 24 Time: 24 weeksDescription: Change from baseline of SGRQ total score at Week 24
Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Week 24 Time: 24 weeksDescription: Change from baseline of Morning trough FEV1 at Week 12
Measure: Morning trough FEV1 at Week 12 Time: 12 weeksDescription: The proportion of St. George's Respiratory Questionnaire (SGRQ) responders at Week 24.
Measure: St. George's Respiratory Questionnaire (SGRQ) responders at Week 24 Time: 24 weeksDescription: Change from baseline of Rescue medication use at Week 24
Measure: Rescue medication use at Week 24 Time: 24 weeksDescription: Transitional Dyspnea Index (TDI) at Week 24
Measure: Transitional Dyspnea Index (TDI) at Week 24 Time: 24 weeksDescription: Change from baseline Evening trough FEV1 at Week 12
Measure: Evening trough FEV1 at Week 12 Time: 12 weeksDescription: Change from baseline Peak FEV1
Measure: Peak FEV1 at Week 6 and Week 24 Time: 6 or 24 weeksDescription: Change from baseline morning trough FEV1
Measure: Morning trough FEV1 at Week 6 and Week 24 Time: 6 or 24 weeksDescription: Change from baseline evening trough FEV1
Measure: Evening trough FEV1 at Week 6 and Week 24 Time: 6 or 24 weeksDescription: Change from baseline FEV1 AUC0-4h
Measure: FEV1 AUC0-4h at Week 6 and Week 24 Time: 6 or 24 weeksDescription: Change from baseline E-RS Total Score
Measure: Evaluating-Respiratory Symptoms (E-RS) Total Score at Week 6 and Week 12 Time: 6 or 12 weeksDescription: Change from baseline SGRQ responder analysis
Measure: SGRQ responder analysis at Week 6 and Week 12 Time: 6 or 12 weeksDescription: Change from baseline TDI
Measure: TDI at Week 6 and Week 12 Time: 6 or 12 weeksDescription: Change from baseline of SGRQ total score
Measure: St. George's Respiratory Questionnaire (SGRQ) total score at Weeks 6 and 12 Time: 6 or 12 weeksDescription: Change from baseline of Rescue medication use
Measure: Rescue medication use at Weeks 6 and 12 Time: 6 or 12 weeksA feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)
Description: The number of patients recruited into this study over a 12-month period
Measure: Feasibility: the number of patients recruited into this study over a 12-month period Time: 12 monthsThis study will evaluate the efficacy and safety of siltuximab compared with normal saline in combination with standard of care (SOC) in selected hospitalized patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with acute respiratory distress syndrome (ARDS) and elevated C-reactive protein (CRP) levels.
Description: 28-day all-cause mortality
Measure: 28-day all-cause mortality Time: Day 28Description: Time to 7-category ordinal scale of clinical status improvement (T7COSCSI)
Measure: Time to 7-category ordinal scale of clinical status improvement (T7COSCSI) Time: Up to 60 daysDescription: Ventilator-free days (VFDs) within 28 days
Measure: Ventilator-free days (VFDs) within 28 days Time: Up to 28 daysDescription: Organ failure-free days (OFFD)
Measure: Organ failure-free days (OFFD) Time: Up to 60 daysDescription: Intensive care unit length of stay (ICU LOS)
Measure: Intensive care unit length of stay (ICU LOS) Time: Up to 60 daysDescription: Hospital length of stay (HLOS)
Measure: Hospital length of stay (HLOS) Time: Up to 60 daysDescription: In-hospital all-cause mortality (IHACM)
Measure: In-hospital all-cause mortality (IHACM) Time: Up to 60 daysDescription: 60-day all-cause mortality (60DACM)
Measure: 60-day all-cause mortality (60DACM) Time: Up to 60 daysDescription: Time to oxygenation improvement (TOI)
Measure: Time to oxygenation improvement (TOI) Time: Up to 60 daysDescription: Duration of supplemental oxygen (DSO)
Measure: Duration of supplemental oxygen (DSO) Time: Up to 60 daysDescription: Chest radiographic improvement (CRI)
Measure: Chest radiographic improvement (CRI) Time: Up to 60 daysDescription: Time to National Early Warning Score 2 improvement (TNEWS2I)
Measure: Time to National Early Warning Score 2 improvement (TNEWS2I) Time: Up to 60 daysDescription: Treatment-emergent adverse events (TEAEs)
Measure: Treatment-emergent adverse events (TEAEs) Time: Up to 60 daysDescription: Plasma siltuximab concentrations (PSCs)
Measure: Plasma siltuximab concentrations (PSCs) Time: Up to 60 daysDescription: Anti-siltuximab antibodies (ASA)
Measure: Anti-siltuximab antibodies (ASA) Time: Up to 60 daysThis is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
Description: Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Measure: Change in Forced Vital Capacity (FVC) Time: Baseline and 180 daysDescription: Death within 90 days and 180 days from enrollment due to a respiratory cause
Measure: Number of deaths due to respiratory cause Time: within 90-180 daysDescription: Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.
Measure: Chest CT visual score Time: 180 daysDescription: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 90Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 180Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief Interstitial Lung Disease (KBILD) Time: Day 90Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief ILD (KBILD) Time: Day 180Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire (LCQ) Time: Day 90Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire Time: Day 180Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: Short Form (SF) 36 Health Survey Time: Day 90Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: SF 36 Health Survey Time: Day 180Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 180Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 90Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 180Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 90Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 180Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 90Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 180Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 90Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 180Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports