Pneumonia, ViralCOVIDEPNCT04479540
Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease
A study testing Angiography scanner in people with Pneumonia, Viral, run by Hopital Foch at 1 site in France.
Trial summary
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Viral
- What is being tested?
- Angiography scanner
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2020to 5 Mar 2022
- 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
- ≥ 18 years
- Any patient who consults in the emergency room, COVID+ with hospitalization criteria (dyspnea or desaturation ≤ 95% or chest pain or hemoptysis), including those who have already performed a CT angiogram upon arrival at the hospital.
- Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical signs associated with suggestive radiological criteria
- Fever
- Cough
- Myalgia
Show all 10Show fewer
- Asthenia
- Loss of taste/ Anosmia
- signed informed consent before any study procedure
- patients affiliated to an appropriate health insurance system
Who cannot join
- Pregnancy in progress
- Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection or whose symptoms are not suggestive
- < 18 years
- Be deprived of liberty or under guardianship
- Patient with contra-indication to thoracic angiography scanner:
- State of shock
Show all 14Show fewer
- Creatinine clearance < 30 mL/mn in Chronic Kidney Disease (CKD)
- history of anaphylactic shock or angioedema with iodinated contrast media
- uncontrolled cardiac decompensation
- Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):
- History of immediate major or delayed skin reaction to the injection of a contrast medium
- Hypersensitivity to the active substance or to any of the excipients
- overt thyrotoxicosis
- Patients with renal insufficiency and / or patients with allergy to iodinated contrast products may be included if they can perform a scintigraphy (the pulmonary scintigraphy being the alternative diagnostic to the CT angiography for renal insufficiency and / or allergy to iodinated contrast products).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).
Read more
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.
To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
Read the detailed description
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are hospitalized in intensive care and 4,503 patients died.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Very little data is available in the medical literature regarding PE during this infection.
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients who are difficult to mobilize.
The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE make it necessary to evaluate the frequency of it in the patients having to be hospitalized by the practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
The main objective of this work is therefore to determine the incidence of the occurrence of PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic angiography scanner in all hospitalized patients.
The secondary objective is to study the coagulation and fibrinolysis profile in these patients and to assess endothelial activation in order to better understand the physio-pathological mechanism behind PE and to determine if one of the parameters studied could be an indicator of PE risk.
- Conditions
- Pneumonia, Viral
- Being tested
- Angiography scanner
- Keywords
- SARS COV-2, pulmonary embolism, acute respiratory distress syndrome, coagulation disorders, venous thromboembolic disease
- Medical subject headings
- Pneumonia, Viral, Pulmonary Embolism, Respiratory Distress Syndrome, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography scannerRadiation
systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized SARS Cov-2 | Experimental | Hospitalized patients diagnosed with SARS Cov-2 infection Receives: Radiation: Angiography scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with pulmonary embolism
Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
Measured: up to Day 12
Secondary outcomes (14)
Prothrombin level measurement
Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
activated partial thromboplastin time measurement
Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Fibrinogen measurement
Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
D-dimers measurement
Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Protein C measurement
Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Willebrand antigen measurement
Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Soluble tissue factor measurement
Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Soluble thrombomodulin measurement
Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
E-selectin measurement
Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Thrombin-antithrombin complex measurement
Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measured: up to Day 12
Assessment of clot formation curve
Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measured: Day 1
Assessment of thrombin generation
Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measured: Day 1
Assessment of fibrinolysis
Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measured: Day 1
Mortality
Determine patient mortality
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start26 May 2020
- Primary completion26 Feb 2022
- Study completion5 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, ViralStudies 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
- Model description
- Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Ambroise Paré Paris, University Hospital, Brest
- Responsible party
- Sponsor
- Investigators
- Colas TCHERAKIAN, MD, Principal investigator, Foch HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479540
- Sponsor's protocol ID
- 2020_0058
- Acronym
- COVIDEP
- Status last verified
- Aug 2022
- First submitted
- 6 Jul 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease
- ClinicalTrials.gov ID
- NCT04479540
- Acronym / sponsor ID
- COVIDEP / 2020_0058
- Conditions
- Pneumonia, Viral
- Keywords
- SARS COV-2, pulmonary embolism, acute respiratory distress syndrome, coagulation disorders, venous thromboembolic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Hospital Ambroise Paré Paris, University Hospital, Brest
- Study start
- 26 May 2020 (actual)
- Primary completion
- 26 Feb 2022 (actual)
- Study completion
- 5 Mar 2022 (actual)
- First posted
- 21 Jul 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 current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.
To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
Detailed description
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are hospitalized in intensive care and 4,503 patients died.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Very little data is available in the medical literature regarding PE during this infection.
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients who are difficult to mobilize.
The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE make it necessary to evaluate the frequency of it in the patients having to be hospitalized by the practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
The main objective of this work is therefore to determine the incidence of the occurrence of PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic angiography scanner in all hospitalized patients.
The secondary objective is to study the coagulation and fibrinolysis profile in these patients and to assess endothelial activation in order to better understand the physio-pathological mechanism behind PE and to determine if one of the parameters studied could be an indicator of PE risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile
| Arm | Type | Receives |
|---|---|---|
| Hospitalized SARS Cov-2 | Experimental | Radiation: Angiography scannerHospitalized patients diagnosed with SARS Cov-2 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years
- Any patient who consults in the emergency room, COVID+ with hospitalization criteria (dyspnea or desaturation ≤ 95% or chest pain or hemoptysis), including those who have already performed a CT angiogram upon arrival at the hospital.
- Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical signs associated with suggestive radiological criteria
- signed informed consent before any study procedure
- patients affiliated to an appropriate health insurance system
Key exclusion criteria (14 listed)
- Pregnancy in progress
- Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection or whose symptoms are not suggestive
- < 18 years
- Be deprived of liberty or under guardianship
- Patient with contra-indication to thoracic angiography scanner:
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 |
|---|---|---|
| Angiography scannersystematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration) | Radiation | Hospitalized SARS Cov-2 |
Primary outcome
Rate of patients with pulmonary embolism
Time frame: up to Day 12
Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
14 secondary outcomes
Prothrombin level measurement
Time frame: up to Day 12
activated partial thromboplastin time measurement
Time frame: up to Day 12
Fibrinogen measurement
Time frame: up to Day 12
D-dimers measurement
Time frame: up to Day 12
Protein C measurement
Time frame: up to Day 12
Willebrand antigen measurement
Time frame: up to Day 12
Soluble tissue factor measurement
Time frame: up to Day 12
Soluble thrombomodulin measurement
Time frame: up to Day 12
E-selectin measurement
Time frame: up to Day 12
Thrombin-antithrombin complex measurement
Time frame: up to Day 12
Assessment of clot formation curve
Time frame: Day 1
Assessment of thrombin generation
Time frame: Day 1
Assessment of fibrinolysis
Time frame: Day 1
Mortality
Time frame: Day 30
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 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Colas TCHERAKIAN, MD principal investigator
Foch HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiography scanner in people with Pneumonia, Viral, run by Hopital Foch at 1 site in France.
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 10 inclusion and 14 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 3 Aug 2022. 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 France. 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?
Rate of patients with pulmonary embolism (time frame: up to Day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.