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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4183 | VIB7734 Wiki | 1.00 |
| drug2916 | Placebo Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055370 | Lung Injury NIH | 0.19 |
| D014947 | Wounds and Injuries NIH | 0.17 |
| D055371 | Acute Lung Injury NIH | 0.08 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
COVID-19 is a disease caused by the virus, SARS-CoV-2. Patients with this viral infection are at risk for developing pneumonia and acute respiratory distress syndrome (ARDS). Approximately 20% to 30% of hospitalized patients with COVID-19 and pneumonia require intensive care for respiratory support. Clinically, ARDS presents with severe hypoxemia evolving over several days to a week in combination with bilateral pulmonary infiltrates on chest X-ray. Widespread alveolar epithelial cell and pulmonary capillary endothelial injury can lead to severe impairment in gas exchange. In one report of 1,099 patients hospitalized with COVID-19, ARDS occurred in 15.6% of patients with severe pneumonia. In a smaller case series of 138 hospitalized patients, ARDS occurred in 19.6% of patients and in 61.1% of patients admitted to an intensive care unit (ICU). To date, no effective treatment has been established to treat COVID-19 or to prevent progression of ARDS. It is thought that a heightened immune response with an unbalanced release of inflammatory mediators in the airway is a major cause of morbidity and mortality associated with the disease. It is therefore reasonable to postulate that improved outcomes may be obtained in patients with a balanced immune response with adequate viral control and appropriate counter-regulatory immune responses whereas a poor outcome may be expected in patients with inadequate viral control or a heightened immune response or what is referred to as a "cytokine storm". Thus, modulating the pulmonary immune response without suppressing the immune system would be a viable strategy for patients with COVID-19. The current literature supports the role of neuromodulation, particularly vagal nerve stimulation (VNS), in modulating the immune response. Modulating the pro-inflammatory pathway through VNS has been demonstrated to decrease inflammatory mediators and improve outcomes in several animal models and in humans. Percutaneous electrical nerve field stimulation (PENFS) provides a novel, non-invasive method of VNS through a non-implantable device applied to the external ear. Already, the FDA has cleared this technology for reducing symptoms of opioid withdrawal in patients with opioid use disorder. Symptoms of opioid withdrawal can be decreased by approximately 90% after 1 hour of stimulation. Similarly, the IB-Stim device has been shown to improve symptom in children with abdominal-pain-related functional GI disorders and recently received market approval by the FDA for that indication. Unpublished studies have demonstrated marked decrease in inflammation with PENFS compared to sham stimulation in a model of TNBS colitis. While the efficacy of PENFS in modulating the progression of pulmonary disease in patients with COVID-19 is unknown, several proposed mechanisms for regulation of the immune response through VNS have already been demonstrated. We propose to perform an open label, randomized study to evaluate the efficacy of PENFS for the treatment of respiratory symptoms in patients with COVID-19.
Description: COVID-19 patients with dyspnea from worsening hypoxemia by measuring daily oxygen level, or saturation (SpO2) in percent.
Measure: Hypoxemia via oxygen level, or saturation (SpO2) in percent Time: up to 14 days or until hospital dischargeDescription: Progression of COVID-19 patients with dyspnea to mechanical ventilation, ECLS or death.
Measure: Progression to mechanical ventilation, ECLS or death Time: up to 14 days or until hospital dischargeDescription: Change in oxygen requirements measured in days of hypoxemia (defined as SpO2 ≤93% on room air or requiring supplemental oxygen)
Measure: Oxygen requirements Time: up to 14 days or until hospital dischargeDescription: Days of hospitalization among survivors
Measure: Days of hospitalization Time: up to 14 days or until hospital dischargeDescription: Time to hospital discharge or "ready for discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or ≤2L supplemental oxygen)
Measure: Time to hospital discharge Time: up to 14 days or until hospital dischargeDescription: Fever will be recorded twice daily. Time to resolution of fever defined as body temperature (≤36.6°C [axilla], or ≤37.2 °C [oral], or ≤37.8°C [rectal or tympanic]) for at least 48 hours without antipyretics or until discharge, whichever is sooner, by clinical severity
Measure: Time to resolution of fever Time: up to 14 days or until hospital dischargeDescription: Days of resting respiratory rate >24 breaths/min recorded twice daily
Measure: Days of resting respiratory rate Time: up to 14 days or until hospital dischargeDescription: Any serious adverse events or patient or worsening condition will be recorded to establish safety and tolerability of PENFS therapy. These include but not limited to skin irritation or reaction at site, pain at site, hypotension, seizure disorders, cardia dysrhythmia, progression to mechanical ventilation.
Measure: Serious adverse events or patient or worsening condition Time: up to 14 days or until hospital dischargeDescription: Evaluation of erythrocyte sedimentation rate (ESR) in mm/hr. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Erythrocyte Sedimentation Rate (ESR) Time: up to 14 days or until hospital dischargeDescription: Evaluation of C-reactive protein (CRP) in mg/dL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: C-Reactive Protein (CRP) Time: up to 14 days or until hospital dischargeDescription: Evaluation of ferritin in ng/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Ferritin Time: up to 14 days or until hospital dischargeDescription: Evaluation of D-dimer in ng/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: D-Dimer Time: up to 14 days or until hospital dischargeDescription: Evaluation of creatine phosphokinase, total (CK) in U/L. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Creatine Phosphokinase, Total (CK) Time: up to 14 days or until hospital dischargeDescription: Evaluation of troponin in ng/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Troponin Time: up to 14 days or until hospital dischargeDescription: Evaluation of lactate dehydrogenase (LDH) in U/L. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Lactate Dehydrogenase (LDH) Time: up to 14 days or until hospital dischargeDescription: Evaluation of procalcitonin (PCT) in ng/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Procalcitonin (PCT) Time: up to 14 days or until hospital dischargeDescription: Evaluation of B-type natriuretic peptide (BNP) in pg/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: B-Type Natriuretic Peptide (BNP) Time: up to 14 days or until hospital dischargeDescription: Evaluation of N-terminal Pro B-type natriuretic peptide (NT-proBNP) in pg/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) Time: up to 14 days or until hospital dischargeDescription: Evaluation of Interleukin-6 (IL-6), high sensitive ELISA in pg/mL. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Interleukin-6 (IL-6), High Sensitive ELISA Time: up to 14 days or until hospital dischargeDescription: Evaluation of complete blood count (CBC) with differential. This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Complete Blood Count (CBC) with Differential Time: up to 14 days or until hospital dischargeDescription: Evaluation of comprehensive metabolic panel (CMP). This will be based on standard of care and additional lab draws for the purpose of the study will not be done.
Measure: Comprehensive Metabolic Panel (CMP) Time: up to 14 days or until hospital dischargeDescription: Clinical status based on: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring low-flow supplemental oxygen Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (related or not related to Covid-19) Hospitalized, not requiring supplemental oxygen or ongoing medical care (other than that specified in the protocol for remdesivir administration) Not hospitalized
Measure: 7-Point Ordinal Scale of Clinical Status Time: up to 14 days or until hospital dischargeDescription: Dyspnea based on: 0 - Nothing at all 0.5 - Very, very slight (just noticeable) - Very slight - Slight - Moderate - Somewhat severe - Severe 7 - Very severe 8 9 - Very, very severe (almost maximal) 10 - Maximal
Measure: Modified Borg Dyspnea Scale (MBS) Time: up to 14 days or until hospital dischargeAlphabetical 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