CovidResearchTrials by Shray Alag

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EDP1815Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)

Name (Synonyms) Correlation
drug187 Ambrisentan Wiki 0.71
drug832 Dapagliflozin Wiki 0.71
drug1849 Nebulized administration of RLF-100 or Placebo Wiki 0.71
drug2343 RLF-100 (aviptadil) Wiki 0.50
drug2707 Standard of care Wiki 0.16
drug2122 Placebo Wiki 0.07

Correlated MeSH Terms (6)

Name (Synonyms) Correlation
D004417 Dyspnea NIH 0.25
D055370 Lung Injury NIH 0.14
D055371 Acute Lung Injury NIH 0.07
D012127 Respiratory Distress Syndrome, Newborn NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D007239 Infection NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002098 Respiratory distress HPO 0.25

There are 2 clinical trials

Clinical Trials

1 mulTi-Arm Therapeutic Study in Pre-ICu Patients Admitted With Covid-19 - Experimental Drugs and Mechanisms (TACTIC-E)

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.

NCT04393246 COVID-19 Drug: EDP1815 Drug: Dapagliflozin Drug: Ambrisentan Other: Standard of care

Primary Outcomes

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 14

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: The duration of oxygen therapy given to a patient, measured in days

Measure: Duration of oxygen therapy

Time: 14 days

Description: The duration of hospitalisation of a patient, measured in days

Measure: Duration of hospitalisation

Time: 14 days

Description: The number of deaths recorded at 28 days irrespective of the cause

Measure: All-cause mortality at day 28

Time: 28 days

Description: 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 days

2 A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection

Evelo will investigate the safety and efficacy of EDP1815 in the treatment of patients hospitalized with SARS-CoV-2 Infection

NCT04488575 Covid19 Drug: EDP1815 Drug: Placebo
MeSH:Infection

Primary Outcomes

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 days

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

No related HPO nodes (Using clinical trials)