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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343053
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

Tracking Information
First Submitted Date  ICMJE April 3, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date November 2, 2022
Actual Study Start Date  ICMJE April 8, 2020
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • reactive oxygen species (ROS) levels [ Time Frame: early stage of disease (first 96 hours) ]
    patterns and changes of ROS
  • reactive oxygen species (ROS) levels [ Time Frame: mid stage of disease (96 hours - 14 days) ]
    patterns and changes of ROS
  • reactive oxygen species (ROS) levels [ Time Frame: late stage of disease (>14 days) ]
    patterns and changes of ROS
  • 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)
  • 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)
  • 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)
  • respiratory function [ Time Frame: 6-month ]
    values of FEV1% as assessed by spirometry
  • respiratory function [ Time Frame: 12-month ]
    values of FEV1% as assessed by spirometry
  • cardiac function [ Time Frame: 6-month ]
    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
  • cardiac function [ Time Frame: 12-month ]
    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
  • clinical outcome [ Time Frame: 12-month ]
    occurrence of death, myocardial infarction, stroke and other major adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pro-thrombotic Status in Patients With SARS-Cov-2 Infection
Official Title  ICMJE Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients With SARS-Cov-2 Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Severe Acute Respiratory Syndrome Coronavirus 2
Intervention  ICMJE Other: SARS-Cov-2 infection
blood sample withdrawal
Study Arms  ICMJE 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
Intervention: Other: SARS-Cov-2 infection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 28, 2021)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2020)
60
Estimated Study Completion Date  ICMJE June 9, 2024
Estimated Primary Completion Date June 9, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Veronica Lodolini 0532237079 ldlvnc@unife.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343053
Other Study ID Numbers  ICMJE 250320
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After specific request to study PIs
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Current Responsible Party Gianluca Campo, University Hospital of Ferrara
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital of Ferrara
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Savino Spadaro, MD Intensive care unit
Principal Investigator: Gianluca Campo, MD Cardiology Unit
Principal Investigator: Marco Contoli, MD Pulmonology Unit
PRS Account University Hospital of Ferrara
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP