Acetylsalicylic acid in the prevention of severe COVID-19 pneumonia in hospitalised patients

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10076502Term: Viral pneumonitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]; Covid-19

• Registration Number: EUCTR2020-006130-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-25
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Hospitalization 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 154

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To verify the efficacy of the administration of acetylsalicylic acid vs placebo in preventing worsening of clinical outcomes in Covid-19 hospitalized patients;Secondary Objective: I. Improvement of clinical indixes,<br>II. Improvement of biomarkers level,<br>III. Improvement of clinical outcomes<br>IV. safety assessment;Primary end point(s): The primaty endpoint is defined as the occurrence of the first of the following events:<br><br>- Transfer to ICU with the need for mechanical ventilation<br>- Death from any cause<br>- PaO2 / FiO2 ratio less than 150 mm Hg;Timepoint(s) of evaluation of this end point: within 15 days since randomization