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 (5)

Name (Synonyms) Correlation
drug342 Dapagliflozin Wiki 1.00
drug57 Ambrisentan Wiki 1.00
drug650 Losartan Wiki 0.38
drug1067 Standard of care Wiki 0.30
drug850 Placebo Wiki 0.09

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.13
D012127 Respiratory Distress Syndrome, Newborn NIH 0.13
D012128 Respiratory Distress Syndrome, Adult NIH 0.11
D003141 Communicable Diseases NIH 0.11
D007239 Infection NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

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. Reference: Gralinski and Baric 2015. Molecular pathology of emerging coronavirus infections. J Pathol 2015: 235: 185-195; DOI: 10.1002/path.4454

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 serum/plasma levels of IL-6, Ferritin, CRP, D-Dimer, neutrophil to lymphocyte ratio, and LDH compared to baseline

Measure: Change in biomarkers known to be associated with progression of COVID-19 compared to baseline

Time: 14 days

Description: For patients receiving EDP1815: change in serum/plasma levels of IL-8, TNF, IL-1β, IL-10, IL-17, IL-13 compared to baseline For patients receiving Dapagliflozin+Ambrisentan: change in serum/plasma levels of ET-1, TNF compared to baseline

Measure: Change in therapy-specific markers of pharmacodynamic response in patients receiving EDP1815 or Dapagliflozin+Ambrisentan compared to baseline

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

No related HPO nodes (Using clinical trials)