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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug267 | Ambrisentan Wiki | 0.71 |
| drug1152 | Dapagliflozin Wiki | 0.35 |
| drug3738 | Standard of care Wiki | 0.14 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.06 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.05 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 2 clinical trials
TACTIC-E is a randomised, parallel arm, open-label platform trial for investigating potential treatments for COVID-19 disease. While SARS-CoV infection evades detection by the immune system in the first 24 hours of infection, it ultimately produces a massive immune system response in the subgroup of people who develop severe complications. Most tissue damage following infection with COVID-19 appears to be due to a later, exaggerated, host immune response (Gralinski and Baric 2015). This leads to lung and sometimes multi-organ damage. Most people who develop these severe complications still have virus present in their respiratory tract at the time-point when the disease starts to evolve. Immune modulation in the presence of active infection has potential to cause more harm than benefit. Safety considerations when studying immune modulation strategies are paramount. This study will assess the efficacy of a novel immunomodulatory agent and a novel combination of approved agents which may protect the patient against end-organ damage and modulate the pulmonary vascular response. This study will compare the novel therapeutic agent EDP1815 and a novel combination of the approved agents dapagliflozin and ambrisentan against Standard of Care.
Description: Number of days taken for occurrence of one of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) <15 ml /min/1.73m^2), haemofiltration or dialysis
Measure: Time to incidence of the composite endpoint of: Death, Mechanical ventilation, ECMO, Cardiovascular organ support, or Renal failure Time: up to Day 14Description: Change in patient blood levels of IL-6 compared to baseline, measured in pg/mL
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: IL-6 Time: 14 daysDescription: Change in patient blood levels of ferritin compared to baseline, measured in ng/mL
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: ferritin Time: 14 daysDescription: Change in patient blood levels of CRP compared to baseline, measured in mg/L
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: c-reactive protein (CRP) Time: 14 daysDescription: Change in patient blood levels of D-dimer compared to baseline, measured in ng/mL
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: D-dimer Time: 14 daysDescription: Change in patient blood levels of neutrophil/lymphocyte ratio compared to baseline
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: neutrophil/lymphocyte ratio Time: 14 daysDescription: Change in patient blood levels of lactate dehydrogenase (LDH) compared to baseline, measured in U/L
Measure: Change in biomarkers thought to be associated with progression of COVID-19 compared to baseline: lactate dehydrogenase (LDH) Time: 14 daysDescription: The clinical status of the patients is assessed using 7-point ordinal scale as follows: 1 = Death, 2 = Mechanical ventilation, 3 = Non-invasive or high flow oxygen, 4 = Low flow oxygen, 5 = Hospitalised - no oxygen, 6 = Discharged - normal activities not resumed, 7 = Discharged - normal activities resumed
Measure: Change in clinical status as assessed on 7-point ordinal scale compared to baseline Time: 14 daysDescription: Number of days taken for occurrence of each of the following events: 1. Death 2. Mechanical ventilation 3. Extracorporeal membrane oxygenation (ECMO) 4. Cardiovascular organ support (balloon pump or inotropes/vassopressors) 5. Renal failure (estimated creatinine clearance (by Cockcroft-Gault formula) <15 ml /min/1.73m^2), haemofiltration or dialysis
Measure: Time to each of the individual endpoints of the composite primary outcome measure Time: 14 daysDescription: The proportion of patients in each treatment arm that experience adverse events of special interest, defined as: Diabetic ketoacidosis in patients on Ambrisentan & Dapagliflozin, New peripheral oedema in patients on Ambrisentan & Dapagliflozin arm
Measure: Proportion of patients with adverse events of special interest in each treatment arm Time: 14 daysDescription: The time taken to achieve blood oxygen saturation levels above 94% in patients on room air, measured in hours/days (chronically hypoxic individuals will be excluded from this analysis)
Measure: Time to Sp02 >94% on room air Time: 14 daysDescription: The amount of time between a patient's first positive SARS-CoV2 PCR test and a patient's first negative SARS-CoV2 PCR test, measured in days
Measure: Time to first negative SARS-CoV2 PCR Time: 14 daysDescription: The duration of oxygen therapy given to a patient, measured in days
Measure: Duration of oxygen therapy Time: 14 daysDescription: The duration of hospitalisation of a patient, measured in days
Measure: Duration of hospitalisation Time: 14 daysDescription: The number of deaths recorded at 28 days irrespective of the cause
Measure: All-cause mortality at day 28 Time: 28 daysDescription: The time to clinical improvement for a patient, defined as: >2 point improvement from Day 1 on the 7-point ordinal scale, measured in days
Measure: Time to clinical improvement Time: 14 daysEvelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection
Description: Pulmonary function as measured by the change in Oxygen Saturation (SpO2) / Fraction of Inspired Oxygen (FiO2) [S/F ratio]
Measure: Change from baseline to the lowest S/F oxygen ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measure: Change in S/F Ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage change in S/F ratio at days 4, 7, 10 and 14/discharge day.
Measure: Percentage change in S/F Ratio Time: 14 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants at each level on the WHO OSCI score at days 4, 7, 14, 21 and 42
Measure: Percentage of participants at each level on the WHO OSCI score Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants with shifts from each level of the WHO OSCI score at baseline at days 4, 7, 14, 21 and 42
Measure: Percentage of participants with shifts from each level of the WHO OSCI score at baseline Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants remaining at their baseline score on the WHO OSCI (or lower) at days 4, 7, 14, 21 and 42
Measure: Percentage of participants remaining at their baseline score on the WHO OSCI (or lower) Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day
Measure: Percentage of participants reporting each level of the WHO OSCI score at their worst post-baseline day Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the time in days spent at each participant's worst reported WHO OSCI score (excluding death).
Measure: The time in days spent at each participant's worst reported WHO OSCI score (excluding death). Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using the intubation and mechanical-ventilation free survival, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 6 or more.
Measure: Intubation and mechanical-ventilation free survival Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using overall survival, defined as the time in days from start of treatment to death by any cause
Measure: Overall survival Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days requiring oxygen therapy
Measure: Number of days requiring oxygen therapy Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using number of days with pyrexia ≥ 38C
Measure: Number of days with pyrexia Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using maximum daily temperature
Measure: Maximum daily temperature Time: 42 daysDescription: The effect of 1815 on the development and severity of complications of COVID-19 infection will be measured using minimum and maximum SpO2 levels
Measure: SpO2 level Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to discharge, defined as the time in days from start of treatment to first occurrence of a WHO OSCI score of 2 or less.
Measure: Time to discharge Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to oxygen saturation (SpO2) ≥94% on room air without further requirement for oxygen therapy.
Measure: Time to oxygen saturation (SpO2) ≥94% Time: 42 daysDescription: The effect of EDP1815 on length of hospitalization and recovery in participants with COVID-19 will be measured using time to recovery, defined as the time in days from symptom onset to alleviation of all COVID-19 symptoms.
Measure: Time to recovery Time: 42 daysDescription: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing AEs by seriousness and relationship to treatment
Measure: Number of participants experiencing AEs by seriousness and relationship to treatment Time: 42 daysDescription: The safety and tolerability of EDP1815 in participants with COVID-19 will be measured using the number of participants experiencing clinically significant abnormal changes in safety lab parameters
Measure: Incidence of clinically significant abnormal lab parameters Time: 42 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