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NCT Number: NCT04343053

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

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

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Key information

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria di Ferrara

Ferrara, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 <200)
  • Diagnosis of SARS-CoV-2 infection + one of the following
  • invasive mechanical ventilation (cohort A)
  • non invasive mechanical ventilation (cohort B)
  • 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

Treatment and study plan

SARS-Cov-2 infection

Other

blood sample withdrawal

Primary outcomes

  1. on-treatment platelet reactivity

    Time frame: 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

  2. on-treatment platelet reactivity

    Time frame: mid stage of disease (96 hours - 14 days)

    patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

  3. on-treatment platelet reactivity

    Time frame: late stage of disease (>14 days)

    patterns and changes of platelet aggregation values assessed by light transmission aggregometry after arachidonic acid, adenosine diphosphate and thrombin receptor activating peptide stimuli

Secondary outcomes

  1. apoptosis rate in human umbilical vein endothelial cells (HUVEC)

    Time frame: 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.

  2. apoptosis rate in human umbilical vein endothelial cells (HUVEC)

    Time frame: mid stage of disease (96 hours - 14 days)

    patterns and changes of the rate of apoptosis in HUVEC incubated with serum from patients enrolled in the study.

  3. Nitric oxide (NO) intracellular levels

    Time frame: 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.

  4. Nitric oxide (NO) intracellular levels

    Time frame: early stage of disease (first 96 hours)

    patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

  5. Nitric oxide (NO) intracellular levels

    Time frame: mid stage of disease (96 hours - 14 days)

    patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.

  6. reactive oxygen species (ROS) levels

    Time frame: early stage of disease (first 96 hours)

    patterns and changes of ROS

  7. reactive oxygen species (ROS) levels

    Time frame: mid stage of disease (96 hours - 14 days)

    patterns and changes of ROS

  8. reactive oxygen species (ROS) levels

    Time frame: late stage of disease (>14 days)

    patterns and changes of ROS

  9. coagulation factors levels

    Time frame: early stage of disease (first 96 hours)

    patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

  10. coagulation factors levels

    Time frame: mid stage of disease (96 hours - 14 days)

    patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

  11. coagulation factors levels

    Time frame: late stage of disease (>14 days)

    patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)

  12. respiratory function

    Time frame: 6-month

    values of FEV1% as assessed by spirometry

  13. respiratory function

    Time frame: 12-month

    values of FEV1% as assessed by spirometry

  14. cardiac function

    Time frame: 6-month

    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

  15. cardiac function

    Time frame: 12-month

    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

  16. clinical outcome

    Time frame: 12-month

    occurrence of death, myocardial infarction, stroke and other major adverse events

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Acronym: ATTAC-Co

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Apr 13, 2020
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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