Covid 19 Research using Clinical Trials (Home Page)
Report for D011654: Pulmonary Edema NIH
(Synonyms: Pulmonary E, Pulmonary Edema)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2018 | PB1046 Wiki | 0.71 |
| drug2278 | Pulmonary Vascular Permeability Index Wiki | 0.71 |
| drug1609 | Low Dose (10 mg) Control Wiki | 0.71 |
| drug323 | Açaí palm berry extract - natural product Wiki | 0.71 |
| drug1061 | Extravascular Lung Water Index Wiki | 0.71 |
| drug313 | Azithromycin Wiki | 0.12 |
| drug1284 | Hydroxychloroquine Wiki | 0.07 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000075902 | Clinical Deterioration NIH | 0.50 |
| D011665 | Pulmonary Valve Insufficiency NIH | 0.27 |
| D006333 | Heart Failure NIH | 0.24 |
| D007249 | Inflammation NIH | 0.14 |
| D055371 | Acute Lung Injury NIH | 0.13 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.13 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.12 |
| D013577 | Syndrome NIH | 0.07 |
| D011014 | Pneumonia NIH | 0.04 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100598 | Pulmonary edema HPO | 1.00 |
| HP:0010444 | Pulmonary insufficiency HPO | 0.27 |
| HP:0001635 | Congestive heart failure HPO | 0.24 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 2 clinical trials
Clinical Trials
1 A Randomized, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of Once Weekly Subcutaneous Injections of PB1046, a Sustained-Release VIP (Vasoactive Intestinal Peptide) ANalogue, in Hospitalized COVID-19 Patients at HiGh Risk for Rapid Clinical Deterioration and ARDS (PB1046 VANGARD Study)
This is a multicenter, randomized, double-blind, parallel group study to investigate the efficacy of PB1046 by improving the clinical outcomes and increasing days alive and free of respiratory failure in hospitalized COVID-19 patients at high risk for rapid clinical deterioration, acute respiratory distress syndrome (ARDS) and death. The study will enroll approximately 210 hospitalized COVID-19 patients who require urgent decision-making and treatment at approximately 20 centers in the United States.
NCT04433546 Acute Respiratory Distress Syndrome Coronavirus Hypoxic Respiratory Failure Hypoxemic Respiratory Failure Respiratory Complication Respiratory Insufficiency Cardiac Dysfunction Pneumonia Pulmonary Edema Pulmonary Inflammation Respiratory Failure Cytokine Storm COVID 19 SARS-CoV-2 Cardiac Event Cardiac Complication Cardiac Failure Cardiac Infarct Drug: PB1046 Drug: Low Dose (10 mg) Control MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Respiratory Insufficiency Acute Lung Injury Pulmonary Edema Pulmonary Valve Insufficiency Heart Failure Syndrome Inflammation Clinical Deterioration
HPO:Congestive heart failure Left ventricular dysfunction Pneumonia Pulmonary edema Pulmonary insufficiency Right ventricular failure
Primary Outcomes
Measure: Days alive and free of respiratory failure from initiation of PB1046 Time: 28 days
Secondary Outcomes
Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge) Time: 28 days
Description: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen
Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization Time: Any time point between injection initiation and Day 28
Measure: All-cause mortality Time: 28 days
Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy
Measure: Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy Time: 28 days
Measure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first. Time: Any time point between injection initiation and Day 28
Measure: Change from baseline in cardiac marker high sensitivity troponin I (hsTnI) Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in cardiac marker NT-proBNP Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in TNF alpha Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in IL-1 Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in IL-6 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Other Outcomes
Measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization Time: Any time point between injection initiation and Day 35+7
Measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization Time: Any time point between injection initiation and Day 35+7
Measure: Incidence of multi-system organ failure (MSOF) Time: Any time point between injection initiation and Day 35+7
Measure: Number of multi-system organ failure (MSOF) free days Time: Any time point between injection initiation and Day 35+7
Measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO) Time: Any time point between injection initiation and Day 35+7
2 Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Primary Outcomes
Measure: Days alive and free of respiratory failure from initiation of PB1046 Time: 28 daysSecondary Outcomes
Measure: Time to clinical recovery (being well enough for hospital discharge or returning to normal baseline activity level prior to discharge) Time: 28 daysDescription: PaO2:FiO2 ratio is the ratio of partial pressure of arterial oxygen to percentage of inspired oxygen
Measure: Development of ARDS (PaO2:FiO2 ratio < 300 mm Hg) during hospitalization Time: Any time point between injection initiation and Day 28Measure: All-cause mortality Time: 28 days
Description: Composite of: Total hospital days, Total ICU days, Total days of ventilator use, Total days of ECMO, Total days of invasive hemodynamic monitoring, Total days of mechanical circulatory support, Total days of inotropic or vasopressor therapy
Measure: Reduction in hospital resource utilization defined as a composite of:total days: in hospital, in ICU, on ventilator, on ECMO, with invasive hemodynamic monitoring, with mechanical circulatory support, and with inotropic or vasopressor therapy Time: 28 daysMeasure: Time to clinical improvement as defined by reduction of at least 2 points on an 8-category ordinal scale of clinical improvement or discharge from hospital, whichever comes first. Time: Any time point between injection initiation and Day 28
Measure: Change from baseline in cardiac marker high sensitivity troponin I (hsTnI) Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in cardiac marker NT-proBNP Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in TNF alpha Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in IL-1 Time: Any time point between injection initiation and Day 35+7
Measure: Change from baseline in IL-6 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by clinical adverse events (AEs) and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by vital signs and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by laboratory results and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by electrocardiogram (ECG) abnormalities and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Measure: Incidence and severity of any treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) as determined by incidence of anti-drug antibodies and their relationship to PB1046 Time: Any time point between injection initiation and Day 35+7
Other Outcomes
Measure: Impact on invasive hemodynamic parameters as measured by pulmonary artery pressure if patients require right-heart catherization Time: Any time point between injection initiation and Day 35+7Measure: Impact on invasive hemodynamic parameters as measured by cardiac output if patients require right-heart catherization Time: Any time point between injection initiation and Day 35+7
Measure: Incidence of multi-system organ failure (MSOF) Time: Any time point between injection initiation and Day 35+7
Measure: Number of multi-system organ failure (MSOF) free days Time: Any time point between injection initiation and Day 35+7
Measure: Number of subjects requiring extracorporeal membrane oxygenation (ECMO) Time: Any time point between injection initiation and Day 35+7
Covid-19 also primarily affects endothelium that line up the alveoli. The resulting hypoxemia may differ from "typical" Acute Respiratory Distress Syndrome (ARDS) due to maldistribution of perfusion related to the ventilation. Thus, pathophysiology of Covid-19 ARDS is different, which requires different interventions than typical ARDS. The investigators will assess whether extravascular lung water index and permeability of the alveolar capillary differs from typical ARDS with transpulmonary thermodilution (TPTD) technique. Extravascular Lung Water Index (EVLWI) and Pulmonary Vascular Permeability Index (PVPI) will be compared.
NCT04508933 Respiratory Distress Syndrome, Adult Ventilation Perfusion Mismatch Pulmonary Edema Covid19 Device: Extravascular Lung Water Index Device: Pulmonary Vascular Permeability Index MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Pulmonary Edema Acute Lung Injury
HPO:Pulmonary edema
Primary Outcomes
Description: The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)
Measure: Extravascular Lung Water Index Time: 1 day
Description: Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution
Measure: Pulmonary vascular permeability index Time: 1 day
HPO Nodes
Primary Outcomes
Description: The amount of fluid accumulated in the lung measured by transpulmonary thermodilution (ml/kg)
Measure: Extravascular Lung Water Index Time: 1 dayDescription: Integrity of the alveolocapillary barrier measured by transpulmonary thermodilution
Measure: Pulmonary vascular permeability index Time: 1 day