Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug323 | Asthma controller therapies (incl. prednisone/prednisolone) Wiki | 0.50 |
| drug1107 | Dupilumab (SAR231893/REGN668) Wiki | 0.50 |
| drug618 | COVID 19 Convalescent Plasma Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug619 | COVID 19 Diagnostic Test Wiki | 0.50 |
| drug466 | Best Standard of Care + CARDIO Wiki | 0.50 |
| drug324 | Asthma reliever therapies Wiki | 0.50 |
| drug2090 | Montelukast Oral Granules Wiki | 0.50 |
| drug621 | COVID 19 diagnostic test by PCR Wiki | 0.50 |
| drug616 | COVI-GUARD Wiki | 0.50 |
| drug465 | Best Standard of Care Wiki | 0.50 |
| drug3433 | Tezepelumab Wiki | 0.35 |
| drug3221 | Standard of Care Wiki | 0.08 |
| drug2505 | Placebo Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001249 | Asthma NIH | 1.00 |
| D001982 | Bronchial Diseases NIH | 0.50 |
| D006969 | Hypersensitivity, Immediate NIH | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012130 | Respiratory Hypersensitivity NIH | 0.50 |
| D011657 | Pulmonary Eosinophilia NIH | 0.50 |
| D006967 | Hypersensitivity, NIH | 0.22 |
| D007154 | Immune System Diseases NIH | 0.20 |
| D008173 | Lung Diseases, Obstructive NIH | 0.14 |
| D008171 | Lung Diseases, NIH | 0.11 |
| D012140 | Respiratory Tract Diseases NIH | 0.11 |
| D007249 | Inflammation NIH | 0.09 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012393 | Allergy HPO | 0.22 |
| HP:0006536 | Pulmonary obstruction HPO | 0.16 |
| HP:0002088 | Abnormal lung morphology HPO | 0.11 |
Navigate: Correlations HPO
There are 4 clinical trials
Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged 5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung function, clinical severity, hospitalization rate and 72-hour symptom burden. Secondary Hypotheses: 1. There are greater effects of high-dose oral montelukast on lung function and on the secondary outcomes in the presence of respiratory viral detection or leukotriene-mediated inflammation; and 2. There is an interaction between viral detection and urinary leukotriene 4 level with treatment-response. Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and severe acute asthma exacerbations. Intervention: High-dose oral montelukast added to standard treatment as one treatment-allocation arm, in comparison with standard treatment as the 2nd treatment-allocation arm. Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure to be compared between arms will be change of %-predicted airway resistance by impulse oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the investigators will determine (1) The effects of high-dose oral montelukast on lung function and on our secondary outcomes in the presence of nasal viruses and of greater leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection and urinary leukotriene E4 (LTE4) level with treatment-response. Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes (%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation. The other secondary outcomes will be measured at the time of hospitalization decision-making by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).
Description: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration
Measure: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry Time: Before and 2-hours after treatment with montelukast or placeboDescription: Change of percent-predicted forced expiratory volume in 1-second (FEV1)
Measure: Change of percent-predicted forced expiratory volume in 1-second (FEV1) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Change of the Acute Asthma Intensity Research Score (AAIRS)
Measure: Change of the Acute Asthma Intensity Research Score (AAIRS) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Leukotriene E4 (LTE4)
Measure: Leukotriene E4 (LTE4) Time: Before treatment with montelukast or placeboDescription: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)
Measure: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD) Time: Before and at 72-hours after treatment with montelukast or placeboDescription: Hospitalization rate
Measure: Hospitalization rate Time: 8-hours after treatment with montelukast or placeboPrimary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64A 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.Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration.The objectives of this randomized, open-label, parallel study is to investigate the safety and efficacy of CARDIO plus best standard-of-care in reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality in hospitalized former smoker and steroid-resistant asthma patients with COVID-19 infection.
Description: Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (oxygen saturation rates) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (supplemental Oxygen) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (ventilator support) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Assessed by the National Early Warning Score (NEWS) which is a standardized tool that assesses disease severity and monitoring of patients in hospital. An aggregate score of respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature and the score is increased if supplemental oxygen is required. Each parameter is based on a scale of 0 - 3. 0=good, 3=poor
Measure: Clinical improvement Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Assessed by the WHO Ordinal Scale for Clinical Improvement which examines changes in clinical status and/or survival specific to COVID-19. This 8-point scale measures illness severity over time. 0 = no infection and 8 = dead
Measure: Clinical status Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.
Measure: Serial chest CT or X-ray findings Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours
Measure: Time to clinical recovery Time: Day 28 from baseline or day of dischargeDescription: increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2
Measure: Time to improvement in oxygenation for at least 48 hours Time: Day 28 from baseline or day of dischargeDescription: The number of days from hospital admission to hospital discharge
Measure: Hospitalization period Time: Day 28 from baseline or day of dischargeDescription: The total number of days on ventilator
Measure: Amount of time on Ventilator Time: Day 28 from baseline or day of dischargeDescription: number of days in intensive care unit (ICU)
Measure: Intensive Care stay Time: Day 28 from baseline or day of dischargeDescription: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree
Measure: Quality of life (QoL) Time: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Death due to COVID-19 and other reasons
Measure: All-cause mortality Time: Day 28 from baseline or day of dischargeDescription: Body temperatures
Measure: Temperature measurements Time: Day 28 from baseline or day of dischargeDescription: measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.
Measure: Oxygen saturation measurements Time: Day 28 from baseline or day of dischargeDescription: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree
Measure: COVID-19 QoL measurements Time: Day 28 from baseline or day of dischargeDescription: Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)
Measure: Adverse Events Time: During 15 days of supplementation or until day of discharge and during home follow upDescription: systolic and diastolic
Measure: Blood pressure Time: From baseline to 28 days thereafterDescription: Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using
Measure: Heart rate Time: Everyday From baseline to 28 days thereafterDescription: Frequency of clinically significant laboratory abnormalities.
Measure: Abnormality in laboratory tests Time: Day 28 from baseline or day of dischargeDescription: BMI values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Body mass Index (BMI) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: CBC values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Complete blood count (CBC) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: AST values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Aspartate transaminase (AST) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: ALT values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Alanine transaminase (ALT) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: ALP values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Alkaline phosphatase (ALP) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Bilirubin values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Bilirubin Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Sodium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Sodium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Potassium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Potassium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Chloride ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Chloride ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Creatinine values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Creatinine Time: Daily From baseline to 28 days thereafterDescription: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: eGFR Time: Daily From baseline to 28 days thereafterDescription: HbA1c values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: HbA1c Time: Daily From baseline to 28 days thereafterDescription: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.
Measure: Glucose Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: CRP value only taken at baseline for every participant
Measure: C-Reactive protein (CRP) Time: Baseline onlyAlphabetical 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