Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There is one clinical trial.
Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence , and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of purinergic receptor P2Y12 inhibitors in pneumococcal pneumonia may improve inflammation and respiratory function in humans. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider a P2Y12 inhibitor for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of P2Y12 inhibitors and the evidence of improvement in respiratory function both in human and experimental pathology. Prasugrel could be considered as an ideal candidate drug for Covid-19 patients because of higher efficacy and limited Interactions with drugs used in the treatment of Sars-CoV2. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with a P2Y12 inhibitor could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs, antibiotics), except for specific contraindications.
Description: PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected after 7 days of treatment
Measure: P/F ratio at day 7 Time: day 7Description: PaO2/FiO2 ratio (arterial oxygen tension divided by the fraction of inspired oxygen) detected daily for 15 days
Measure: Daily P/F ratio Time: 15 daysDescription: daily need for oxygen supply for 15 days
Measure: Daily need for oxygen supply Time: 15 daysDescription: Number of patients requiring transfer to the intensive care unit (ICU) by treatment arm
Measure: Need for ICU Time: day 15 and day 30Description: death by day 15 and day 30 by treatment arm
Measure: Death Time: 15 day and day 30Description: Multi-organ failure (MOF) by day 15 and day 30 assessed using sequential organ failure assessment score (SOFA) score (Units 0-4 better outcome, over 30 worse outcome) by treatment arm
Measure: MOF Time: day 15 and day 30Description: Number of patients discharged after improvement by day 15 and day 30 by treatment arm
Measure: Discharge Time: day 15 and day 30Description: Clinical progression of the disease evaluated by SOFA score (Units 0-6 better outcome, 15-24 worse outcome) by day 15 and day 30
Measure: Clinical progression of the disease SOFA score Time: day 15 and day 30Description: Clinical progression of the disease evaluated by Acute Physiology And Chronic Health Evaluation (APACHE II) score (Units 1-5 better outcome, over 30 worse outcome) by day 15 and day 30
Measure: Clinical progression of the disease APACHE II Time: day 15 and day 30Description: Number of patients with venous thrombosis/ pulmonary embolism/thrombosis by day 15 and day 30
Measure: Venous thrombosis/ pulmonary embolism/thrombosis Time: day 15 and day 30Description: Number of patients requiring computerized tomography (CT) imaging due to worsening of respiratory function by treatment arm
Measure: Need for CT imaging Time: day 15Description: Body temperature measured twice daily for 15 days, C°
Measure: Daily Temperature Time: 15 daysDescription: Blood pressure measured twice daily for 15 days, mmHg
Measure: Daily blood pressure Time: 15 daysDescription: Total blood count measured in venous blood for 15 days, Hemoglobin, g/L (cell/mcL
Measure: Daily total blood count Hemoglobin Time: 15 daysDescription: Total blood count measured in venous blood for 15 days, Red Blood cells (cell/mcL)
Measure: Daily total blood count Red Blood Cells Time: 15 daysDescription: Total blood count measured in venous blood for 15 days, Leukocytes (cell/mcL)
Measure: Daily total blood count Leukocytes Time: 15 daysDescription: Total blood count measured in venous blood for 15 days, platelets (cell/mcL)
Measure: Daily total blood count Platelets Time: 15 daysDescription: ALT U/L in venous blood
Measure: Daily indices of organ damage Liver Time: 15 daysDescription: C-reactive protein microg/L in venous blood
Measure: Indices of inflammation C-reactive protein Time: day 1, 2, 7, 15Description: PT ratio in venous blood by treatment arm
Measure: Indices of haemostasis PT Time: day 1, 2, 7,15Description: progression of lung infiltrates as detected by chest-X-ray by treatment arm
Measure: Daily progression at imaging (chest-X-ray) Time: 15 daysDescription: Major and/or clinically relevant bleeding according to International Society of Thrombosis and Haemostasis (ISTH) bleeding scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.
Measure: Major bleeding Time: day 1, 2, 7, 15, 30Description: Total bleeding according to International Society of Thrombosis and Haemostasis (ISTH bleeding) scale (Unit 0 better outcome, 4 worse outcome, 11 items) during treatment.
Measure: Total bleeding Time: day 1, 2, 7, 15, 30Description: Number of unexpected changes in clinical or laboratory findings not included in the predefined list of outcomes during treatment. .
Measure: Unexpected clinical or laboratory findings Time: day 1, 2, 7, 15Description: D-dimer microg/L in venous blood
Measure: Indices of inflammation D-dimer Time: day 1, 2, 7, 15Description: Fibrinogen g/L in venous blood
Measure: Indices of inflammation Fibrinogen Time: day 1, 2, 7, 15Description: Interleukin (IL)-6 pg/mL in venous blood by treatment arm
Measure: Indices of inflammation IL-6 Time: day 1, 2, 7, 15Description: Interleukin (IL)-1 pg/mL in venous blood by treatment arm
Measure: Indices of inflammation IL-1 Time: day 1, 2, 7, 15Description: serum creatinine micromol/L by treatment arm
Measure: Daily indices of organ damage kidney Time: 15 daysDescription: troponin t ng/L by treatment arm
Measure: Daily indices of organ damage heart Time: 15 daysDescription: aPTT ratio by treatment arm
Measure: Haemostasis aPTT Time: day 1, 2, 7,15Description: Vasodilator stimulated phosphoprotein (VASP) phosphorylation (PRI) % by treatment arm
Measure: Haemostasis VASP PRI Time: day 1, 2, 7,15Description: Platelet-leukocytes aggregates % in peripheral by treatment arm
Measure: Haemostasis platelet-leukocytes aggregates Time: day 1, 2, 7,15Alphabetical 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