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Pro-thrombotic Status in Patients With SARS-Cov-2 Infection (ATTAC-Co)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343053
Recruitment Status : Active, not recruiting
First Posted : April 13, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

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

Condition or disease Intervention/treatment Phase
Severe Acute Respiratory Syndrome Coronavirus 2 Other: SARS-Cov-2 infection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Technicians performing assays will be blinded to stage of the infection and outcomes
Primary Purpose: Diagnostic
Official Title: Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients With SARS-Cov-2 Infection
Actual Study Start Date : April 8, 2020
Actual Primary Completion Date : June 9, 2020
Estimated Study Completion Date : June 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SARS-Cov-2 infection
Single study group of patients with respiratory failure due to SARS-Cov-2 infection. Three blood samples will be collected at different stages of disease: early, defined as first 96 hours, mid, defined as time from 96 hours and 14 days, late. defined as >14 days
Other: SARS-Cov-2 infection
blood sample withdrawal




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04343053


Locations
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Italy
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Principal Investigator: Savino Spadaro, MD Intensive care unit
Principal Investigator: Gianluca Campo, MD Cardiology Unit
Principal Investigator: Marco Contoli, MD Pulmonology Unit
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Responsible Party: Gianluca Campo, Associate Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT04343053    
Other Study ID Numbers: 250320
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After specific request to study PIs
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases