Acetylsalicylic Acid in the Prevention of Severe SARS-CoV2 Pneumonia in Hospitalised Patients With COVID-19

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• 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 acetylsalicylic acid may improve inflammation and respiratory function in humans as indicated by the results of observational studies. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider acetylsalicylic acid 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 antiplatelet agents and the evidence of improvement in respiratory function both in human and experimental pathology. 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 acetylsalicylic acid 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), except for specific contraindications. To this aim, the investigators a randomised, placebo-controlled, double blind, parallel arms study to investigate the potential protection of acetylsalicylic acid towards the progression of lung failure in patients admitted to a medical ward for SARS-CoV-2 pneumonia. A 15-day treatment period is considered. Primary endpoint is the occurrence of one of the following events: admission to an intensive care unit, requirement of mechanical ventilation, PaO2/FiO2 less than 150 mm Hg.

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

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• in a medical area ward dedicated to Covid-19 patients

• Positivity by RT_PCR of the search for genetic material of SARS-CoV2

• Covid-19 pneumonia with moderate clinical picture based on clinical parameters

• O2 saturation> 94% with maximum FiO2 32%

• Respiratory acts <30 / minute

• age >18 years

• Consent to participate in the study

Exclusion Criteria:

• Any Antithrombotic treatment including acetylsalicylic acid

• Active Bacterial infection

• Active or in maintenance therapy neoplasm

• Inability to provide consent

• Any contraindication to the acetylsalicylic acid use

• Active peptic disease

• Active Major pathological bleeding

• Recent (<30 days) major bleeding

• Recent intracranial bleeding

• Need to use therapeutic doses of oral anticoagulants or heparins

• Need to use combination antiplatelet drugs for clinical indication

• Hypersensitivity to acetylsalicylic acid or to any of the excipients

• Hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)

• Severe hepatic insufficiency (Child-Pugh class C).

• Severe heart failure (NYHA class 3-4)

• Platelet count less than 150000 / mmc

• Haemostasis alteration (INR> 1.5, APTT> 1.5)

• Plasma fibrinogen <100 mg / dL

• Blood pressure >160/100 mmHg

• Concomitant treatment with serotonin reuptake inhibitors

• Participation in another pharmacological clinical trial