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

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Trial

— ATTAC-Co  

Official title:

Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients With SARS-Cov-2 Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04343053
• Other study ID #: 250320
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2020
• Est. completion date: November 12, 2024

Study information

• Verified date: November 2023
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: November 12, 2024
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Severe Acute Respiratory Syndrome
• Severe Acute Respiratory Syndrome Coronavirus 2

Intervention

Other:
• SARS-Cov-2 infection
blood sample withdrawal

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

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