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    HP:0006536: Pulmonary obstruction

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (22)


    Name (Synonyms) Correlation
    drug3433 Tezepelumab Wiki 0.45
    drug1600 ION-827359 Wiki 0.32
    drug3103 Serology for Covid-19 Wiki 0.32
    Name (Synonyms) Correlation
    drug3183 Sputum and blood sampling Wiki 0.32
    drug619 COVID 19 Diagnostic Test Wiki 0.32
    drug1587 ID NOW vs. Accula Wiki 0.32
    drug1095 Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Wiki 0.32
    drug2966 SARS-CoV-2 rS/Matrix-M1 Adjuvant Wiki 0.32
    drug1601 IP-10 in CDS protocol Wiki 0.32
    drug94 ARALAST NP Wiki 0.32
    drug891 Control swab Wiki 0.32
    drug2685 Prototype swab Wiki 0.32
    drug1742 Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment Wiki 0.32
    drug401 BI 764198 Wiki 0.22
    drug38 2D Telemedicine Wiki 0.22
    drug46 3D Telemedicine Wiki 0.18
    drug1978 Matching placebo Wiki 0.18
    drug390 BCG vaccine Wiki 0.18
    drug464 Best Practice Wiki 0.14
    drug3257 Standard treatment Wiki 0.13
    drug2505 Placebo Wiki 0.07
    drug3485 Tocilizumab Wiki 0.05

    Correlated MeSH Terms (34)


    Name (Synonyms) Correlation
    D008173 Lung Diseases, Obstructive NIH 0.88
    D029424 Pulmonary Disease, Chronic Obstructive NIH 0.64
    D008171 Lung Diseases, NIH 0.41
    Name (Synonyms) Correlation
    D029481 Bronchitis, Chronic NIH 0.32
    D001991 Bronchitis NIH 0.32
    D001982 Bronchial Diseases NIH 0.32
    D006969 Hypersensitivity, Immediate NIH 0.32
    D012130 Respiratory Hypersensitivity NIH 0.32
    D018410 Pneumonia, Bacterial NIH 0.32
    D004646 Emphysema NIH 0.22
    D000208 Acute Disease NIH 0.22
    D019896 Alpha 1-Antitrypsin Deficiency NIH 0.22
    D003139 Common Cold NIH 0.18
    D001249 Asthma NIH 0.16
    D006967 Hypersensitivity, NIH 0.14
    D012140 Respiratory Tract Diseases NIH 0.13
    D007154 Immune System Diseases NIH 0.13
    D007676 Kidney Failure, Chronic NIH 0.12
    D003327 Coronary Disease NIH 0.12
    D003324 Coronary Artery Disease NIH 0.12
    D006331 Heart Diseases NIH 0.10
    D012120 Respiration Disorders NIH 0.08
    D020521 Stroke NIH 0.08
    D011024 Pneumonia, Viral NIH 0.07
    D002318 Cardiovascular Diseases NIH 0.06
    D007249 Inflammation NIH 0.06
    D009369 Neoplasms, NIH 0.06
    D012141 Respiratory Tract Infections NIH 0.06
    D007239 Infection NIH 0.05
    D045169 Severe Acute Respiratory Syndrome NIH 0.04
    D018352 Coronavirus Infections NIH 0.04
    D011014 Pneumonia NIH 0.03
    D014777 Virus Diseases NIH 0.03
    D003141 Communicable Diseases NIH 0.02

    Correlated HPO Terms (12)


    Name (Synonyms) Correlation
    HP:0006510 Chronic pulmonary obstruction HPO 0.74
    HP:0002088 Abnormal lung morphology HPO 0.44
    HP:0012387 Bronchitis HPO 0.32
    Name (Synonyms) Correlation
    HP:0004469 Chronic bronchitis HPO 0.32
    HP:0002099 Asthma HPO 0.16
    HP:0012393 Allergy HPO 0.14
    HP:0001677 Coronary artery atherosclerosis HPO 0.13
    HP:0001297 Stroke HPO 0.09
    HP:0011947 Respiratory tract infection HPO 0.06
    HP:0002664 Neoplasm HPO 0.06
    HP:0001626 Abnormality of the cardiovascular system HPO 0.06
    HP:0002090 Pneumonia HPO 0.04

    Clinical Trials

    Navigate: Correlations   HPO

    There are 10 clinical trials


    1 Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease (COPD) and During Acute Exacerbations of COPD (AECOPD), in Asia Pacific

    Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.

    NCT03151395
    Conditions
    1. Respiratory Disorders
    Interventions
    1. Other: Sputum and blood sampling
    MeSH:Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases
    HPO:Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.

    Measure: Occurrence of potential bacterial in sputum of stable COPD patients.

    Time: Over the course of 1 year

    Description: Bacterial pathogens, as identified by bacteriological methods, including (but not necessarily limited to) Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii.

    Measure: Occurrence of potential bacterial in sputum during AECOPD.

    Time: Over the course of 1 year

    Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.

    Measure: Occurrence of viral pathogens in sputum of stable COPD patients.

    Time: Over the course of 1 year

    Description: Viral pathogens, as identified by PCR, including (but not necessarily limited to) Respiratory syncytial virus (RSV), parainfluenza virus, enterovirus/ rhinovirus, metapneumovirus, influenza virus, adenovirus, bocavirus and coronavirus and by rhinovirus quantitative RT-PCR.

    Measure: Occurrence of viral pathogens in sputum during AECOPD.

    Time: Over the course of 1 year

    Secondary Outcomes

    Description: Including (but not necessarily limited to) H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus and P. aeruginosa. The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens by PCR will be computed with 95% confidence intervals.

    Measure: Occurrence of potential bacterial pathogens in sputum of stable COPD patients and during AECOPD, as measured by real-time qualitative PCR/ quantitative PCR and compared to data from bacteriological methods.

    Time: Over the course of 1 year

    Description: The proportion of sputum samples obtained at each AECOPD visit and positive for specific bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial/viral species) will be computed with 95% confidence intervals by any severity (mild, moderate and severe).

    Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum during AECOPD by severity of AECOPD.

    Time: Over the course of 1 year

    Description: The proportion of sputum samples obtained at each confirmed stable visit and positive for bacterial/viral pathogens by bacteriological methods and PCR, respectively (overall and by bacterial / viral species) will be computed with 95% confidence intervals by Gold grade at enrolment.

    Measure: Occurrence of potential bacterial and viral pathogens (overall and by species) in sputum of stable COPD patients by GOLD grade.

    Time: Over the course of 1 year

    Description: The following incidence rates will be computed, with 95% confidence intervals (CI): All-cause AECOPD. AECOPD having sputum containing bacterial pathogens found by PCR or by bacteriological methods or by both methods (overall and by, but not limited to, the following bacterial species: H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, and P. aeruginosa). The 95% CI of the incidence rate will be computed using a model which accounts for repeated events. The incidence rates described above will also be computed for mild, moderate severe AECOPD and by GOLD grade at enrolment.

    Measure: Incident rate (per subject per year) of any AECOPD overall and by GOLD grade.

    Time: Over the course of 1 year

    Description: Classification of severity according to the intensity of medical intervention required: mild: controlled with an increase in dosage of regular medications; moderate: requires treatment with systemic corticosteroids and/ or antibiotics; severe: requires hospitalisation.

    Measure: Number of mild, moderate or severe AECOPD overall and by GOLD grade.

    Time: Over the course of 1 year

    Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the number of days of AECOPD episodes will be presented.

    Measure: Number of days of AECOPD episodes overall and by AECOPD severity.

    Time: Over the course of 1 year

    Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the CAT scores will be tabulated at each respective visit.

    Measure: COPD assessment test (CAT) score in stable COPD patients and during AECOPD.

    Time: Over the course of 1 year

    Description: Descriptive statistics (median, mean, range, standard deviation, first and third quartiles) on the SGRQ-C scores will be tabulated at each respective visit.

    Measure: St. George's Respiratory Questionnaire (SGRQ-C) score in stable COPD patients.

    Time: Over the course of 1 year

    Description: The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator FEV1. Summary statistics (mean, median, standard deviation, maximum and minimum) on post bronchodilator FEV1% of predicted normal value will be tabulated at each respective visit.

    Measure: Forced expiratory volume in 1 second (FEV1%) of predicted normal value in stable COPD patients.

    Time: At Pre-Month 0 and Month 12

    Description: Healthcare use for each COPD patient will be obtained through review of the subject's medical record (aided by subject self-reporting). Healthcare utilisation includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations.

    Measure: Assessment of the Healthcare utilization.

    Time: Over the course of 1 year
    2 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)

    A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.

    NCT03688074
    Conditions
    1. Asthma
    2. Bronchial Diseases
    3. Respiratory Tract Diseases
    4. Lung Diseases, Obstructive
    5. Lung Diseases
    6. Respiratory Hypersensitivity
    7. Hypersensitivity, Immediate
    8. Hypersensitivity
    9. Immune System Diseases
    Interventions
    1. Biological: Tezepelumab
    2. Other: Placebo
    MeSH:Asthma Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Inflammation
    HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction

    Primary Outcomes

    Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

    Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Secondary Outcomes

    Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

    Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

    Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

    Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
    3 A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

    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)

    NCT04039113
    Conditions
    1. Chronic Obstructive Pulmonary Disease (COPD)
    Interventions
    1. Biological: Tezepelumab
    2. Other: Placebo
    MeSH:Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive
    HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    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 Weeks

    Secondary Outcomes

    Description: 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 52

    Description: 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 Weeks

    Description: 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 Weeks

    Description: 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 52

    Description: 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 52

    Description: 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 52

    Description: 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 52

    Description: Serum trough concentration of tezepelumab

    Measure: Evaluate pharmacokinetics of tezepelumab

    Time: Weeks 0, 4, 12, 24, 36, 52, 64

    Description: Incidence of anti-drug antibodies (ADA)

    Measure: Evaluate immunogenicity of tezepelumab

    Time: Over 52 weeks
    4 Time of Recovery and Prognostic Factors of COVID-19 Pneumonia

    It 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.

    NCT04324684
    Conditions
    1. Pneumonia, Viral
    2. Hypertension
    3. Diabetes Mellitus
    4. Obesity
    5. Cardiovascular Diseases
    6. Obstructive Lung Disease
    MeSH:Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive Cardiovascular Diseases
    HPO:Abnormal lung morphology Abnormality of the cardiovascular system Pneumonia Pulmonary obstruction

    Primary Outcomes

    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 weeks

    Secondary Outcomes

    Description: 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 weeks

    Description: the efficacy of different pharmaceutical treatment against Covid-19

    Measure: efficacy of treatments

    Time: 3 weeks

    Description: liver, kidney or multiorgan failure, cardiac failure

    Measure: organ failure

    Time: 3 weeks
    5 Audio Data Collection for Identification and Classification of Coughing

    An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

    NCT04326309
    Conditions
    1. COVID-19
    2. Coronavirus Infections
    3. Hay Fever
    4. Asthma
    5. Chronic Obstructive Pulmonary Disease
    6. Influenza
    7. Common Cold
    8. Respiratory Tract Infections
    9. Healthy
    MeSH:Infection Communicable Diseases Respiratory Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Common Cold Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive
    HPO:Chronic pulmonary obstruction Pulmonary obstruction Respiratory tract infection

    Primary Outcomes

    Description: Size of collected audio dataset measured as number of collected cough sounds, targeting ≥10,000 identified coughs.

    Measure: Dataset size

    Time: 14 days

    Secondary Outcomes

    Description: Identification of cough sounds by the existing mathematical model with ≥ 99% specificity and ≥ 60% sensitivity

    Measure: Cough sound identification

    Time: 14 days

    Description: Increase in the sensitivity of the mathematical model to cough sounds to ≥ 70% while retaining the specificity of ≥ 99%

    Measure: Improvement of the existing model

    Time: 14 days

    Description: Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.

    Measure: Evaluate the usability of the application

    Time: 14 days
    6 Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial

    This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

    NCT04361552
    Conditions
    1. Cerebrovascular Accident
    2. Chronic Obstructive Pulmonary Disease
    3. Chronic Renal Failure
    4. Coronary Artery Disease
    5. Diabetes Mellitus
    6. Malignant Neoplasm
    7. SARS Coronavirus 2 Infection
    Interventions
    1. Other: Best Practice
    2. Biological: Tocilizumab
    MeSH:Infection Neoplasms Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Stroke Kidney Failure, Chronic Coronary Artery Disease
    HPO:Chronic pulmonary obstruction Coronary artery atherosclerosis Neoplasm Pulmonary obstruction Stroke

    Primary Outcomes

    Description: The 7-day length of invasive MV for each arm will be estimated with 95% confidence intervals (CIs) using the exact binomial distribution. Their difference by the arms will be tested by Cochran-Mantel-Haenszel (CMH) test stratified by the age group and Sequential Organ Failure Assessment (SOFA) score at significance level of 0.05.

    Measure: 7-day length of invasive mechanical ventilation (MV)

    Time: Up to 7 days

    Description: Defined as death within 30-day after randomization. The 30-day mortality rate for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: 30-day mortality rate

    Time: Up to 30-day after randomization

    Secondary Outcomes

    Description: The rate of ICU transfer for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of intensive care (ICU) transfer

    Time: Up to 2 years

    Description: The rate of invasive mechanical ventilation for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of invasive mechanical ventilation

    Time: Up to 2 years

    Description: The rate of tracheostomy for each arm will be estimated with 95% CIs using the exact binomial distribution. Their difference by the arms will be tested CMH test stratified by the age group and SOFA score at significance level of 0.05.

    Measure: Rate of tracheostomy

    Time: Up to 2 years

    Description: Will first be described by median and inter-quartile, and then compared between two arms by Wilcoxon Sum-Rank test

    Measure: Length of ICU stay

    Time: Up to 2 years

    Measure: Length of hospital stay

    Time: Up 2 years
    7 Major Determinants of COVID-19 Associated Pneumonia

    Molecular 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.

    NCT04387799
    Conditions
    1. Pneumonia, Viral
    2. Pneumonia, Bacterial
    3. Coronavirus Infection
    4. Obstructive Lung Disease
    Interventions
    1. Diagnostic Test: Serology for Covid-19
    MeSH:Pneumonia, Bacterial Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Lung Diseases Lung Diseases, Obstructive
    HPO:Abnormal lung morphology Pneumonia Pulmonary obstruction

    Primary Outcomes

    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 weeks

    Secondary Outcomes

    Description: 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 weeks

    Description: the efficacy of different pharmaceutical treatments against Covid-19

    Measure: Efficacy of different pharmaceutical treatments

    Time: 3 weeks
    8 A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial

    Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied

    NCT04414267
    Conditions
    1. COVID-19
    2. Virus Diseases
    3. Corona Virus Infection
    4. Coronary Heart Disease
    5. Chronic Obstructive Pulmonary Disease
    Interventions
    1. Biological: BCG vaccine
    2. Biological: Placebo
    MeSH:Infection Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Heart Diseases Coronary Disease
    HPO:Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    Description: This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: One situation definitively related to COVID-19 All four questions of symptoms possibly related to COVID-19 At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" Positive IgG or IgM antibodies against SARS-CoV-2

    Measure: Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3.

    Time: Visit 3 (90 +/- 5 days)

    Secondary Outcomes

    Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint on visit 4

    Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4

    Time: Visit 4 (135 +/- 5 days)

    Description: The two groups of vaccination are compared for the primary endpoints which is composite (as defined at primary study endpoint) and meet a positive respiratory questionnaire endpoint (as defined at primary study endpoint) on visit 5

    Measure: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5

    Time: Visit 5 (180 +/- 5 days)

    Description: Prevalence of IgG/IgM against SARS-CoV-2 will be measured among the patients who failed the eligibility procedure and the patients that were eligible and were enrolled

    Measure: Prevalence of IgG/IgM against SARS-CoV-2

    Time: Screening Visit and Visit 3 (90 +/- 5 days)

    Description: Itemized analysis of each of the components of the respiratory questionnaire on each study visit

    Measure: Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.

    Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: The impact of new cardiovascular events between the two study groups (placebo and BCG) will be analyzed, though the collection of any cardiovascular events occured to the enrolled patients.

    Measure: The impact of new cardiovascular events between the two study groups

    Time: Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of arterial stiffness in visit 3 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

    Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 3 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

    Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of endothelial function in visit 3 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 3 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 3

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)

    Description: Differences in repeated measurements of arterial stiffness in visit 5 between the two sub-study groups (placebo or BCG) will be analyzed through the speed of the pulse wave velocity. Pulse wave velocity is measured in m/sec.

    Measure: Differences in repeated measurements of angiometric parameters (arterial hardness) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of central arterial pressures and reflected waves in visit 5 between the two sub-study groups (placebo or BCG) will be measured non-invasively by pulse wave analysis. Central arterial pressure is measured in mmHg.

    Measure: Differences in repeated measurements of angiometric parameters (central arterial pressures and reflected waves) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of thickness of the medial carotid sheath in visit 5 between the two sub-study groups (placebo or BCG) will be measured by B-mode ultrasound examination. Intima-Media Thickness is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (thickness of the medial carotid sheath) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in repeated measurements of endothelial function in visit 5 between the two sub-study groups (placebo or BCG) will be measured by ultrasound measurement of endothelium-dependent flow-mediated dilatation and by nitrate-mediated dialatation. Endothelial function will be assessed by Flow Mediated Dilatation (FMD). Endothelium-dependent: diameter of the artery prior and after temporary ischemia in is measured in mm, nitrate-mediated: diameter of the artery prior and after nitrate administration is measured in mm

    Measure: Differences in repeated measurements of angiometric parameters (endothelial function) between the two sub-study groups in Visit 5

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Differences in cardiac ultrasound at visit 5 between the two sub-study groups (placebo or BCG) will be assessed using standard measurements from 2-D and Doppler echocardiography.

    Measure: Differences in cardiac ultrasound at visit 5 between the two sub-study groups

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days), Visit 5 (180 +/- 5 days)

    Description: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups (placebo or BCG) will be analyzed

    Measure: Changes in the release of cytokines from blood mononuclear cells at visit 3 between the two sub-study groups

    Time: Visit 1 (Day 0), Visit 3 (90 +/- 5 days)
    9 A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of ARALAST NP 60 mg/kg and 120 mg/kg for Alpha-1 Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E)

    The 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.

    NCT04440488
    Conditions
    1. Chronic Obstructive Pulmonary Disease
    2. Alpha1-antitrypsin Deficiency
    Interventions
    1. Biological: ARALAST NP
    MeSH:Alpha 1-Antitrypsin Deficiency Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Emphysema
    HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    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 104

    Secondary Outcomes

    Description: 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 104

    Description: 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 104

    Description: 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, 105
    10 A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis

    The 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.

    NCT04441788
    Conditions
    1. Chronic Bronchitis
    2. Chronic Obstructive Pulmonary Disease
    Interventions
    1. Drug: ION-827359
    2. Drug: Placebo
    MeSH:Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Bronchitis, Chronic Acute Disease
    HPO:Abnormal lung morphology Bronchitis Chronic bronchitis Chronic pulmonary obstruction Pulmonary obstruction

    Primary Outcomes

    Measure: Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo

    Time: From Baseline up to average of Weeks 13 and 14

    Secondary Outcomes

    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 14

    Description: 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 14

    Measure: Change from Baseline in Post-Bronchodilator FEV1

    Time: From Baseline up to average of Weeks 13 and 14

    Measure: Cmax: Maximum Observed Plasma Concentration for ION-827359

    Time: Up to Week 24

    Measure: Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359

    Time: Up to Week 24

    Measure: AUC[0-t]: Area Under the Plasma Concentration-Time Curve from Time Zero to t for ION-827359

    Time: Up to Week 24

    Measure: Incidence of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), Graded by Severity

    Time: Up to Week 24

    Measure: Number of Participants With Abnormal Laboratory Values

    Time: Up to Week 24

    Measure: Number of Participants With Abnormal Vital Signs Measurements

    Time: Up to Week 24

    HPO Nodes


    Reports

    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.

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    691 reports on MeSH terms

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