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CompletedNCT04343053ATTAC-CoUpdated Dec 12, 2024

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

An interventional study of SARS-Cov-2 infection in Severe Acute Respiratory Syndrome Coronavirus 2, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Severe Acute Respiratory Syndrome Coronavirus 2
03

In context

Lead sponsor

University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 29 are open to participants now.

Browse University Hospital of Ferrara studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous chronic use of P2Y12 inhibitors
  • Need for chronic oral anti-coagulation therapy
  • Know disorder of coagulation or platelet function
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
145 participants (actual)

Study arms

  • Other
    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

Interventions

  • OtherSARS-Cov-2 infection

    blood sample withdrawal

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. Nitric oxide (NO) intracellular levels

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

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

  4. Nitric oxide (NO) intracellular levels

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

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

  5. Nitric oxide (NO) intracellular levels

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

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

  6. reactive oxygen species (ROS) levels

    patterns and changes of ROS

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

  7. reactive oxygen species (ROS) levels

    patterns and changes of ROS

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

  8. reactive oxygen species (ROS) levels

    patterns and changes of ROS

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

  9. coagulation factors levels

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

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

  10. coagulation factors levels

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

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

  11. coagulation factors levels

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

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

  12. respiratory function

    values of FEV1% as assessed by spirometry

    Time frame: 6-month

  13. respiratory function

    values of FEV1% as assessed by spirometry

    Time frame: 12-month

  14. cardiac function

    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

    Time frame: 6-month

  15. cardiac function

    values of left ventricular ejection fraction as assessed by transthoracic echocardiogram

    Time frame: 12-month

  16. clinical outcome

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

    Time frame: 12-month

07

Study locations

1 site
  • Azienda Ospedaliera Universitaria di Ferrara
    Ferrara, Italy
08

References and documents

Publications

  • Scaramuzzo G, Ronzoni L, Campo G, Priani P, Arena C, La Rosa R, Turrini C, Volta CA, Papi A, Spadaro S, Contoli M. Long-term dyspnea, regional ventilation distribution and peripheral lung function in COVID-19 survivors: a 1 year follow up study. BMC Pulm Med. 2022 Nov 9;22(1):408. doi: 10.1186/s12890-022-02214-5. PubMed 36352423 ↗
  • Contoli M, Papi A, Tomassetti L, Rizzo P, Vieceli Dalla Sega F, Fortini F, Torsani F, Morandi L, Ronzoni L, Zucchetti O, Pavasini R, Fogagnolo A, Volta CA, Bartlett NW, Johnston SL, Spadaro S, Campo G. Blood Interferon-alpha Levels and Severity, Outcomes, and Inflammatory Profiles in Hospitalized COVID-19 Patients. Front Immunol. 2021 Mar 9;12:648004. doi: 10.3389/fimmu.2021.648004. eCollection 2021. PubMed 33767713 ↗
  • 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. Markers of endothelial and epithelial pulmonary injury in mechanically ventilated COVID-19 ICU patients. Crit Care. 2021 Feb 19;25(1):74. doi: 10.1186/s13054-021-03499-4. PubMed 33608030 ↗
  • Campo G, Contoli M, Fogagnolo A, Vieceli Dalla Sega F, Zucchetti O, Ronzoni L, Verri M, Fortini F, Pavasini R, Morandi L, Biscaglia S, Di Ienno L, D'Aniello E, Manfrini M, Zoppellari R, Rizzo P, Ferrari R, Volta CA, Papi A, Spadaro S. Over time relationship between platelet reactivity, myocardial injury and mortality in patients with SARS-CoV-2-associated respiratory failure. Platelets. 2021 May 19;32(4):560-567. doi: 10.1080/09537104.2020.1852543. Epub 2020 Dec 3. PubMed 33270471 ↗

Individual participant data

Plan to share: Yes — After specific request to study PIs

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in Nov 2023, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2020
First posted
Apr 13, 2020
StartActual
Apr 8, 2020
Primary completionActual
Nov 12, 2023
CompletionActual
Dec 7, 2024
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04343053
Lead sponsor
University Hospital of Ferrara
Responsible party
Gianluca Campo (Associate Professor, University Hospital of Ferrara) — Principal investigator
First posted
Apr 13, 2020
Start date
Apr 8, 2020
Primary completion
Nov 12, 2023
Completion
Dec 7, 2024
Last update
Dec 12, 2024

Study contacts

Savino Spadaro, MD
principal investigator · Intensive care unit
Gianluca Campo, MD
principal investigator · Cardiology Unit
Marco Contoli, MD
principal investigator · Pulmonology Unit

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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