Prasugrel in Severe COVID-19 Pneumonia

• Status: Not yet recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Collaborator: University of Milan
• Treatments: Prasugrel Hydrochloride

Criteria

Inclusion Criteria:

• Covid-19 pneumonia

• Age over 18 years

• Willingness to express consent

Exclusion Criteria:

• Active neoplasia or in maintenance therapy

• Pregnancy and breastfeeding

• Any absolute contraindication to the use of antiplatelet drugs

• Pathological bleeding in progress.

• Recent major bleeding at any location

• Need to use therapeutic doses of oral anticoagulants or heparins

• Need to use antiplatelet in combination for clinical indication

• Hypersensitivity to the active substance prasugrel or any of the excipients

• Clinical history of stroke or transient ischemic attack (TIA).

• Severe liver failure (Child-Pugh class C).