Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
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drug2066 | Kaplan Meier analysis Wiki | 1.00 |
drug3490 | SOC plus Placebo IV Wiki | 1.00 |
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Navigate: Correlations HPO
There is one clinical trial.
Current standard of care (SOC) for the management of hospitalized COVID-19 cases differs in various North American hospitals, particularly in the pharmacological treatments used, and is constantly changing. At the moment, available options (depending on the hospital's treatment protocol, the physician's medical judgment, contraindications, and disease presentation) include hydroxychloroquine, chloroquine, remdesivir, ceftriaxone, azithromycin, piperacillin-tazobactam, lopinavir-ritonavir, and IL-6 receptor antagonists. In most hospital treatment protocols, the use of the latter is generally to be considered in patients with evidence of cytokine release syndrome and elevated IL-6, on a case-by-case basis. Adults who suffer major COVID-19 complications appear to present a major inflammatory storm. Therefore, targeting the inflammatory response may reduce COVID-19-related complications in adults at risk or with evidence of an inflammatory storm. EB05 is a potent inhibitor of TLR4, a key component of the innate immune system which functions to detect molecules generated by pathogens, acting upstream of cytokine storm and IL-6-mediated acute lung injury. EB05 has demonstrated safety in two clinical studies (>165 patients) and was able to block LPS-induced (TLR4 agonist) IL-6 release in humans. Furthermore, TLR4 blockade rescued mice from lethal influenza-induced Acute Respiratory Distress Syndrome (ARDS), a major cause of mortality associated with COVID-19, thus could be useful in the management of COVID-19. Given, this extensive body of evidence we believe EB05 could ameliorate ARDS due to COVID-19, significantly reducing ventilation rates and mortality.
Description: The severity of COVID-19 related respiratory disease is assessed on the following seven-point ordinal scale: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; hospitalized, requiring Extracorporeal Membrane Oxygenation (ECMO), invasive mechanical ventilation, or both, and; death. For the current study the primary efficacy outcome measure will be the proportion of patients with clinical improvement at 28 days of follow-up, defined as an improvement of two points on the seven-point ordinal scale.
Measure: An improvement of two points on the seven-point ordinal scale Time: 28 daysDescription: Time to clinical improvement by 2 points on the seven-point ordinal scale described in primary outcome.
Measure: Time to clinical improvement by 2 points on the seven-point ordinal scale described in primary outcome. Time: 28 daysDescription: Ventilator-free days.
Measure: Ventilator-free days. Time: 28 daysDescription: Duration of ventilation
Measure: Duration of ventilation Time: 28 daysDescription: Mortality rate
Measure: Mortality rate Time: 28 daysDescription: Duration of hospitalization
Measure: Duration of hospitalization Time: 28 daysDescription: Time to independence from supplementary oxygen therapy
Measure: Time to independence from supplementary oxygen therapy Time: 28 daysDescription: Time to normalization of oxygen saturation, defined as Sp02 > 94% sustained minimum 24 hours
Measure: Time to normalization of oxygen saturation, defined as Sp02 > 94% sustained minimum 24 hours Time: 24 hoursDescription: Change in four-point Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized
Measure: Change in four-point Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized Time: 28 daysDescription: Radiological response to treatment based on Thoracic Computerized Tomography Scan (CT-Scan) or Chest X-Ray
Measure: Radiological response to treatment based on Thoracic Computerized Tomography Scan (CT-Scan) or Chest X-Ray Time: 28 daysDescription: Change in cytokines, including IL-6, and C-reactive protein (CRP) levels
Measure: Change in cytokines, including IL-6, and C-reactive protein (CRP) levels Time: 28 daysDescription: Defined as post-baseline body temperature <37.2°C (oral), or <37.6°C (rectal or tympanic) or <36.8°C (temporal or axillary).
Measure: Time to resolution of fever for at least 48 hours without antipyretics Time: 28 daysDescription: Decision by the attending physician to initiate treatment with another targeted immunomodulator (i.e. IL-6 inhibitors)
Measure: Decision by the attending physician to initiate treatment with another targeted immunomodulator (i.e. IL-6 inhibitors) Time: 28 daysDescription: Change in the four-point Berlin ARDS severity scale
Measure: Change in the four-point Berlin ARDS severity scale Time: 28 daysDescription: Change in three-point Acute Kidney Injury Network (AKIN) classification
Measure: Change in three-point Acute Kidney Injury Network (AKIN) classification Time: 28 daysDescription: Change in troponin levels
Measure: Change in troponin levels Time: 28 daysDescription: Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs.
Measure: Safety Endpoint: Number of treatment-emergent adverse events (TEAEs) and serious TEAEs. Time: 28 daysAlphabetical 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