deltatrials
Completed NA INTERVENTIONAL 1-arm NCT04343053

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

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

Sponsor: University Hospital of Ferrara

Updated 11 times since 2020 Last updated: Dec 7, 2024 Started: Apr 8, 2020 Primary completion: Nov 12, 2023 Completion: Dec 7, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Severe Acute Respiratory Syndrome Coronavirus 2, this trial is completed. The trial is conducted by University Hospital of Ferrara and has accumulated 11 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~May 2020 – ~Jun 2020 · 31 days · monthly snapshotRecruiting~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshotRecruiting~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotActive Not Recruiting~Oct 2021 – ~Dec 2022 · 14 months · monthly snapshotRecruiting~Dec 2022 – ~Dec 2023 · 12 months · monthly snapshotRecruiting~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshotActive Not Recruiting~Jan 2025 – present · 15 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Jan 2025 — Present [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  3. Sep 2024 — Jan 2025 [monthly]

    Active Not Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  5. Dec 2023 — Jul 2024 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

Show 6 earlier versions
  1. Dec 2022 — Dec 2023 [monthly]

    Recruiting NA

  2. Oct 2021 — Dec 2022 [monthly]

    Recruiting NA

    Status: Active Not RecruitingRecruiting

  3. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting NA

  4. Jul 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  5. Jun 2020 — Jul 2020 [monthly]

    Recruiting NA

  6. May 2020 — Jun 2020 [monthly]

    Recruiting NA

    First recorded

Apr 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University Hospital of Ferrara
Data source: University Hospital of Ferrara

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations