The present study is ideated to prospectively investigate in patients with severe acute respiratory syndrome (SARS) due to Coronavirus 19 (SARS-Cov-2) infection and moderate-severe respiratory failure the patterns and changes in platelet reactivity, thrombotic status and endothelial function. The observed patterns and changes will be related with inflammatory status, myocardial injury and outcomes
Preliminary evidences suggested that patients with SARS-Cov-2 infection and concomitant presence of cardiovascular risk factors (i.e. arterial hypertension) and/or cardiovascular history (i.e. prior myocardial infarction) are at poor prognosis. The first reports from China suggested in patients with SARS-Cov-2 infection a heightened inflammatory burden associated with significant changes in coagulative status (i.e. low platelet count, increased D-dimer) and dysfunction of micro-vessels in pulmonary circulation. No data are available about patterns and changes in platelet reactivity, activation of coagulation factors and endothelial function during SARS-Cov-2 infection. The present study is ideated to fill this gap. Patients with moderate to severe respiratory failure due to SARS-Cov-2 infection will be enrolled. One blood sample will be obtained from each patient at the early, mid and late stage of disease. Several markers of platelet, coagulation and endothelial function will be related with laboratory, clinical, electrocardiographic, imaging (transthoracic echocardiogram, pulmonary ultrasonography, computed tomography) and outcome data. To better describe typical patterns of disease regarding inflammation, platelet function and coagulation alteration, data from cases will be compared with control groups negative for SARS-CoV-2 infection, but with ST-segment elevation myocardial infarction or moderate-severe respiratory failure due to other agents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
145
blood sample withdrawal
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
on-treatment platelet reactivity
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Time frame: early stage of disease (first 96 hours)
on-treatment platelet reactivity
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Time frame: mid stage of disease (96 hours - 14 days)
on-treatment platelet reactivity
patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli
Time frame: late stage of disease (>14 days)
apoptosis rate in human umbilical vein endothelial cells (HUVEC)
patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
Time frame: early stage of disease (first 96 hours)
apoptosis rate in human umbilical vein endothelial cells (HUVEC)
patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
Time frame: mid stage of disease (96 hours - 14 days)
Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Time frame: late stage of disease (>14 days)
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Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Time frame: early stage of disease (first 96 hours)
Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Time frame: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Time frame: early stage of disease (first 96 hours)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Time frame: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Time frame: late stage of disease (>14 days)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Time frame: early stage of disease (first 96 hours)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Time frame: mid stage of disease (96 hours - 14 days)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Time frame: late stage of disease (>14 days)
respiratory function
values of FEV1% as assessed by spirometry
Time frame: 6-month
respiratory function
values of FEV1% as assessed by spirometry
Time frame: 12-month
cardiac function
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Time frame: 6-month
cardiac function
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Time frame: 12-month
clinical outcome
occurrence of death, myocardial infarction, stroke and other major adverse events
Time frame: 12-month