Covid-19 MedDRA version: 20.0 Level: LLT Classification code 10076502 Term: Viral pneumonitis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Acido Acetilsalicilico
Product Code: [Acido Acetilsalicilico]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ACIDO ACETILSALICILICO
CAS Number: 50-78-2
Current Sponsor code: Aci
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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 ( 1.5, APTT> 1.5) • Plasma fibrinogen 160/100 mmHg • Concomitant treatment with serotonin reuptake inhibitors • Participation in another pharmacological clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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, II. Improvement of biomarkers level, III. Improvement of clinical outcomes IV. safety assessment;Primary end point(s): The primaty endpoint is defined as the occurrence of the first of the following events: - Transfer to ICU with the need for mechanical ventilation - Death from any cause - PaO2 / FiO2 ratio less than 150 mm Hg;Timepoint(s) of evaluation of this end point: within 15 days since randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): IIIa. Clinical progression (combined clinical indexes: ROX index, Sofa score, Apache score) after 7 and after 15 days of treatment IIIb. Need to perform chest CT scan due to worsening of gas exchange after 7 and after 15 days of treatment IIIc. Admission to ICU after 7 and after 15 days of treatment IIId. Need for mechanical ventilation after 7 and after 15 days of treatment IIIe. Days free from mechanical ventilation after 7 and 15 days of treatment IIIf. Venous thrombosis / pulmonary embolism or pulmonary thrombosis, deficiency multiorgan (MOF) or cardiovascular event after 7 and 15 days of treatment IIIg. Death IIIh. Discharge for clinical resolution; IIa. Indexes of inflammation (complete blood count with leukocyte count, CRP, D-dimer, chitokines IL-1, IL-6, fibrinogen, albumin) before randomization, after 24 hours and 48 hours, after 7 and after 15 days IIb. Platelet and haemostatic indexes (serum Thromboxane B2, 11-dehydro Thromboxane XB2 urinary, platelet count, cross-linked platelets, platelet / leukocyte conjugates, plasma P-selectin a and platelet P-selectin expression before randomization, after 24 hours and 48 hours, after 7 and after 15 days IIc. Coagulation indexes (aPTT and TP) before randomization, after 24 hours and 48 hours, after 7 and after 15 days; Ia.Body temperature (every 24 hours for all 15 days of treatment) Ib. Respiratory acts / minute (every 24 hours for all 15 days of treatment) Ic. Arterial O2 saturation and blood gas analysis (At 7 and 15 days after randomization) Id. blood count with platelet count, cross-linked platelets, platelet morphovolumetry, eosinophil count (every 24 hours for all 15 days of treatment) Ie. Use of oxygen if saturation <92% (every 24 hours for all 15 days of treatment) If. PaO2/FiO2 ratio (every 24 hours for all 15 days of treatment) Ig. Progression of the radiological picture (within 15 days of treatment) Ih. Organ damage indexes (transaminases, troponin, creatinemia) (every 2 | — |
Countries
Italy
Contacts
Public ContactUOC MEDICINA C
Azienda Ospedaliera Universitaria Integrata Verona
Outcome results
None listed