CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Prasugrel Hydrochloride 10 MG Oral TabletWiki

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


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D013927 Thrombosis NIH 0.23
D011014 Pneumonia NIH 0.06

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

1 Prasugrel in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients

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.

NCT04445623 COVID19 Thrombosis Drug: Prasugrel Hydrochloride 10 MG Oral Tablet Drug: Placebo
MeSH:Pneumonia Thrombosis
HPO:Pneumonia

Primary Outcomes

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 7

Secondary Outcomes

Description: 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 days

Description: daily need for oxygen supply for 15 days

Measure: Daily need for oxygen supply

Time: 15 days

Description: Number of patients requiring transfer to the intensive care unit (ICU) by treatment arm

Measure: Need for ICU

Time: day 15 and day 30

Description: death by day 15 and day 30 by treatment arm

Measure: Death

Time: 15 day and day 30

Description: 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 30

Description: Number of patients discharged after improvement by day 15 and day 30 by treatment arm

Measure: Discharge

Time: day 15 and day 30

Description: 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 30

Description: 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 30

Description: 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 30

Description: Number of patients requiring computerized tomography (CT) imaging due to worsening of respiratory function by treatment arm

Measure: Need for CT imaging

Time: day 15

Description: Body temperature measured twice daily for 15 days, C°

Measure: Daily Temperature

Time: 15 days

Description: Blood pressure measured twice daily for 15 days, mmHg

Measure: Daily blood pressure

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, Hemoglobin, g/L (cell/mcL

Measure: Daily total blood count Hemoglobin

Time: 15 days

Description: 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 days

Description: Total blood count measured in venous blood for 15 days, Leukocytes (cell/mcL)

Measure: Daily total blood count Leukocytes

Time: 15 days

Description: Total blood count measured in venous blood for 15 days, platelets (cell/mcL)

Measure: Daily total blood count Platelets

Time: 15 days

Description: ALT U/L in venous blood

Measure: Daily indices of organ damage Liver

Time: 15 days

Description: C-reactive protein microg/L in venous blood

Measure: Indices of inflammation C-reactive protein

Time: day 1, 2, 7, 15

Description: PT ratio in venous blood by treatment arm

Measure: Indices of haemostasis PT

Time: day 1, 2, 7,15

Description: progression of lung infiltrates as detected by chest-X-ray by treatment arm

Measure: Daily progression at imaging (chest-X-ray)

Time: 15 days

Description: 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, 30

Description: 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, 30

Description: 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, 15

Description: D-dimer microg/L in venous blood

Measure: Indices of inflammation D-dimer

Time: day 1, 2, 7, 15

Description: Fibrinogen g/L in venous blood

Measure: Indices of inflammation Fibrinogen

Time: day 1, 2, 7, 15

Description: Interleukin (IL)-6 pg/mL in venous blood by treatment arm

Measure: Indices of inflammation IL-6

Time: day 1, 2, 7, 15

Description: Interleukin (IL)-1 pg/mL in venous blood by treatment arm

Measure: Indices of inflammation IL-1

Time: day 1, 2, 7, 15

Description: serum creatinine micromol/L by treatment arm

Measure: Daily indices of organ damage kidney

Time: 15 days

Description: troponin t ng/L by treatment arm

Measure: Daily indices of organ damage heart

Time: 15 days

Description: aPTT ratio by treatment arm

Measure: Haemostasis aPTT

Time: day 1, 2, 7,15

Description: Vasodilator stimulated phosphoprotein (VASP) phosphorylation (PRI) % by treatment arm

Measure: Haemostasis VASP PRI

Time: day 1, 2, 7,15

Description: Platelet-leukocytes aggregates % in peripheral by treatment arm

Measure: Haemostasis platelet-leukocytes aggregates

Time: day 1, 2, 7,15

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0