Severe Acute Respiratory Syndrome Coronavirus 2ATTAC-CoNCT04343053
Pro-thrombotic Status in Patients with SARS-Cov-2 Infection
A study testing SARS-Cov-2 infection in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- SARS-Cov-2 infection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2020to 7 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous chronic use of P2Y12 inhibitors
- Need for chronic oral anti-coagulation therapy
- Know disorder of coagulation or platelet function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized 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
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.
- Being tested
- SARS-Cov-2 infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-Cov-2 infectionOther
blood sample withdrawal
| Study group | Role | What they receive |
|---|---|---|
| SARS-Cov-2 infection | Other | 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 Receives: Other: SARS-Cov-2 infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: early stage of disease (first 96 hours)
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
Measured: mid stage of disease (96 hours - 14 days)
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
Measured: late stage of disease (>14 days)
Secondary outcomes (16)
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.
Measured: early stage of disease (first 96 hours)
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.
Measured: mid stage of disease (96 hours - 14 days)
Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measured: late stage of disease (>14 days)
Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measured: early stage of disease (first 96 hours)
Nitric oxide (NO) intracellular levels
patterns and changes of intracellular level of NO in HUVEC incubated with serum from patients enrolled in the study.
Measured: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Measured: early stage of disease (first 96 hours)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Measured: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
patterns and changes of ROS
Measured: late stage of disease (>14 days)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measured: early stage of disease (first 96 hours)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measured: mid stage of disease (96 hours - 14 days)
coagulation factors levels
patterns and changes of the most important coagulation factors (i.e. tissue factor antigen pg/dL)
Measured: late stage of disease (>14 days)
respiratory function
values of FEV1% as assessed by spirometry
Measured: 6-month
respiratory function
values of FEV1% as assessed by spirometry
Measured: 12-month
cardiac function
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Measured: 6-month
cardiac function
values of left ventricular ejection fraction as assessed by transthoracic echocardiogram
Measured: 12-month
clinical outcome
occurrence of death, myocardial infarction, stroke and other major adverse events
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Apr 2020
- Primary completion12 Nov 2023
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
- Investigators
- Savino Spadaro, MD, Principal investigator, Intensive care unitGianluca Campo, MD, Principal investigator, Cardiology UnitMarco Contoli, MD, Principal investigator, Pulmonology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343053
- Sponsor's protocol ID
- 250320
- Acronym
- ATTAC-Co
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After specific request to study PIs
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 36352423Contoli 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 33767713Spadaro 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 33608030Campo 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Changes in Platelet Reactivity, Thrombotic Status and Endothelial Function in Hospitalized Patients with SARS-Cov-2 Infection
- ClinicalTrials.gov ID
- NCT04343053
- Acronym / sponsor ID
- ATTAC-Co / 250320
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 12 Nov 2023 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-Cov-2 infection | Other | Other: SARS-Cov-2 infectionSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of moderate-severe respiratory failure (PaO2/FiO2 <200)
- Diagnosis of SARS-CoV-2 infection + one of the following
Key exclusion criteria (3 listed)
- Previous chronic use of P2Y12 inhibitors
- Need for chronic oral anti-coagulation therapy
- Know disorder of coagulation or platelet function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SARS-Cov-2 infectionblood sample withdrawal | Other | SARS-Cov-2 infection |
Primary outcome
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
16 secondary outcomes
apoptosis rate in human umbilical vein endothelial cells (HUVEC)
Time frame: early stage of disease (first 96 hours)
apoptosis rate in human umbilical vein endothelial cells (HUVEC)
Time frame: mid stage of disease (96 hours - 14 days)
Nitric oxide (NO) intracellular levels
Time frame: late stage of disease (>14 days)
Nitric oxide (NO) intracellular levels
Time frame: early stage of disease (first 96 hours)
Nitric oxide (NO) intracellular levels
Time frame: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
Time frame: early stage of disease (first 96 hours)
reactive oxygen species (ROS) levels
Time frame: mid stage of disease (96 hours - 14 days)
reactive oxygen species (ROS) levels
Time frame: late stage of disease (>14 days)
coagulation factors levels
Time frame: early stage of disease (first 96 hours)
coagulation factors levels
Time frame: mid stage of disease (96 hours - 14 days)
coagulation factors levels
Time frame: late stage of disease (>14 days)
respiratory function
Time frame: 6-month
respiratory function
Time frame: 12-month
cardiac function
Time frame: 6-month
cardiac function
Time frame: 12-month
clinical outcome
Time frame: 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 36352423Scaramuzzo 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.
- Derived from this study: PubMed 33767713Contoli 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.
- Derived from this study: PubMed 33608030Spadaro 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.
- Derived from this study: PubMed 33270471Campo 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.
- Individual participant dataSharing planned: Yes. After specific request to study PIs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savino Spadaro, MD principal investigator
Intensive care unit
Gianluca Campo, MD principal investigator
Cardiology Unit
Marco Contoli, MD principal investigator
Pulmonology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SARS-Cov-2 infection in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
on-treatment platelet reactivity (time frame: early stage of disease (first 96 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343053, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.