Pro-thrombotic Status in Patients with SARS-Cov-2 Infection

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Brief summary

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

Detailed description

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.

Scaramuzzo G, Ronzoni L, Campo G, Priani P, Arena C, La Rosa R, Turrini C, Volta CA, Papi A, Spadaro S, Contoli M.

2022-11-0929 citations

10.1186/s12890-022-02214-5

Blood Interferon-α Levels and Severity, Outcomes, and Inflammatory Profiles in Hospitalized COVID-19 Patients

Marco Contoli, Alberto Papi, L. Tomassetti, Paola Rizzo, Francesco Vieceli Dalla Sega et al. (17 authors)

Frontiers in Immunology2021-03-0998 citations

10.3389/fimmu.2021.648004

Markers of endothelial and epithelial pulmonary injury in mechanically ventilated COVID-19 ICU patients.

Spadaro S, Fogagnolo A, Campo G, Zucchetti O, Verri M, Ottaviani I, Tunstall T, Grasso S, Scaramuzzo V, Murgolo F, Marangoni E, Vieceli Dalla Sega F, Fortini F, Pavasini R, Rizzo P, Ferrari R, Papi A, Volta CA, Contoli M.

2021-02-19114 citations

10.1186/s13054-021-03499-4

Over time relationship between platelet reactivity, myocardial injury and mortality in patients with SARS-CoV-2-associated respiratory failure

Gianluca Campo, Marco Contoli, Alberto Fogagnolo, Francesco Vieceli Dalla Sega, Ottavio Zucchetti et al. (20 authors)

Platelets2020-12-0347 citations

10.1080/09537104.2020.1852543

Interventions

OTHERSARS-Cov-2 infection

blood sample withdrawal

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

Technicians performing assays will be blinded to stage of the infection and outcomes

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 \<200) * Diagnosis of SARS-CoV-2 infection + one of the following 1. invasive mechanical ventilation (cohort A) 2. non invasive mechanical ventilation (cohort B) 3. only oxygen support

Exclusion criteria

* Previous chronic use of P2Y12 inhibitors * Need for chronic oral anti-coagulation therapy * Know disorder of coagulation or platelet function

Design outcomes

Primary

Measure	Time frame	Description
on-treatment platelet reactivity	early stage of disease (first 96 hours)	patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Secondary

Measure	Time frame	Description
respiratory function	6-month	values of FEV1% as assessed by spirometry
apoptosis rate in human umbilical vein endothelial cells (HUVEC)	early stage of disease (first 96 hours)	patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.
Nitric oxide (NO) intracellular levels	late stage of disease (>14 days)	patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
reactive oxygen species (ROS) levels	early stage of disease (first 96 hours)	patterns and changes of ROS
coagulation factors levels	early stage of disease (first 96 hours)	patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
cardiac function	6-month	values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
clinical outcome	12-month	occurrence of death, myocardial infarction, stroke and other major adverse events

Countries

Italy

Outcome results

None listed