Coronavirus Disease 2019NCT05330832
Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)
An observational study of Coronavirus Disease 2019, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
The aim of the study is estimating the predictive and preventative capability of thrombodynamics for severe pneumonia coagulopathy complications in patients with COVID-19 infection. Thrombodynamics test is a method for blood coagulation and anticoagulation monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Thrombodynamics test
- How many people
- 2,200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2020to 21 Apr 2022
- Phase
- Observational
- 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
Study population: Study population consists of hospitalized patients with confirmed COVID-19 infection from April till December 2020 from 5 Moscow hospitals #40, 51, 23, 64 and the Troitsk hospital.
Who may be able to join
- Patient (or the health care surrogate) Informed consent
- Confirmed COVID-19 diagnosis
Who cannot join
- 1) Patient (or the health care surrogate) refusal to participate in this study
Trial locations and contacts
1 site in 1 country.
Russia1 site
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
About this study
The aim of the study is estimating the predictive and preventative capability of thrombodynamics for severe pneumonia coagulopathy complications in patients with COVID-19 infection. Thrombodynamics test is a method for blood coagulation and anticoagulation monitoring. It could be a useful tool for predicting thrombohemorrhagic complications in patients with COVID-19 infection and developing a novel scheme of anticoagulant therapy.
Inclusion criteria are the following: patient informed concern, confirmed COVID-19 diagnosis, state of modern or critical condition.
Read the detailed description
The novel coronavirus viral infection (currently classified as COVID-19) causes a significant increase in death rate worldwide. Most of the patients with COVID-19 develop respiratory failure as well as coagulopathy.
The International Society of Thrombosis and Hemostasis (ISTH) has recently published guidelines for the treatment of coagulopathies in patients with COVID-19. It suggests using prophylactic doses of low molecular weight heparin (LMWH) in all patients with COVID-19. Numerous studies show a high percentage of thromboembolic complications in patients with COVID-19 as well as its potential association with pulmonary vessels microthrombosis and the development of acute respiratory distress syndrome. It is believed that COVID-19-associated coagulopathy could happen presumably due to the systemic inflammation. However, there are still no unified criteria for anticoagulant prophylaxis in such patients.
What is more, the severity of COVID-19 infection is also associated with high risk of life-threatening conditions such as sepsis and disseminated intravascular coagulation syndrome with massive uncontrolled bleeding.
According to the current clinical guidelines, coagulopathy in COVID-19 can be only registered with standard tests (prothrombin time (PT), platelet concentration and D-dimer). However, the lengthening of PT and the drop in platelet concentration are useful for the indication of the consumption stage of DIC. These changes mean that any patient remains already at risk of bleeding and the LMWH is no longer effective. The concentration of D-dimers shows the lysis of clots formed as a result of hypercoagulation, which also makes it a "delayed" marker of hypercoagulation. Thus, there are currently no reliable laboratory tools for hypercoagulation diagnostics in patients with COVID-19.
Thrombodynamics test is a global hemostasis test that allows to register the dynamics of fibrin clot formation in time and space. This test is highly sensitive to both hyper- and hypocoagulation and, at the same time, it allows to control anticoagulant therapy with heparins. The use of thrombodynamics test for the prediction of thrombohemorrhagic complications in this group of patients could be useful for individual correction of anticoagulant treatment and prevention of coagulopathy in COVID-19.
The aim of the study is estimating the predictive capability of thrombodynamics for SARS-CoV-2 associated coagulopathy in patients with severe pneumonia.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Thrombodynamics test
- Keywords
- COVID-19, venous thromboembolism, pulmonary embolism, myocardial infarction, ischemic stroke, atherothrombosis
- Medical subject headings
- COVID-19, Venous Thromboembolism, Pulmonary Embolism, Myocardial Infarction, Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombodynamics testDiagnostic test
Thrombodynamics test is a global hemostasis test that allows to register the dynamics of fibrin clot formation in time and space. It requires whole blood samples from included patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed SARS-Cov-2 infection | Hospitalized patients with modern or critical condition with confirmed COVID-19 infection. Patients received standard therapy for COVID-19 infection and anticoagulant prophylaxis if needed according to current temporary clinical recommendations. Receives: Diagnostic Test: Thrombodynamics test |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Outcome Measure - In-hospital mortality rate
Measured: From study enrollment until the date of death from any cause, assessed up to 4 months
Secondary outcomes (7)
Myocardial infarction
Percentage of patients with in-hospital myocardial infarction
Measured: 4 months from study enrollment
Ischemic stroke
Percentage of patients with in-hospital ischemic stroke
Measured: 4 months from study enrollment
Arterial thrombosis
Percentage of patients with in-hospital arterial thrombosis
Measured: 4 months from study enrollment
Venous thromboembolism,
Percentage of patients with in-hospital venous thromboembolism
Measured: 4 months from study enrollment
DVT
Percentage of patients with in-hospital disseminated intravascular coagulation
Measured: 4 months from study enrollment
Percentage of patients in moderate condition with in-hospital clinical deterioration
(respiratory rate > 30 per minute, SpO2 ≤ 93%, PaO2 /FiO2 ≤ 300 mm Hg, CT chest findings of the increase in the area of infiltrative changes for more than 50% in 24-48 hours, respiratory support necessity, unstable hemodynamics, multiple-organ-failure syndrome, qSOFA score > 2, arterial blood lactate > 2 mmol)
Measured: 4 months from study enrollment
Percentage of patients in moderate critical with in-hospital clinical deterioration
(respiratory support necessity, unstable hemodynamics, multiple-organ-failure syndrome, qSOFA score > 2, arterial blood lactate > 2 mmol)
Measured: 4 months from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Apr 2020
- Primary completion15 Dec 2020
- Study completion21 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330832
- Sponsor's protocol ID
- NCHPOI-2021-11
- Status last verified
- Jan 2022
- First submitted
- 22 Feb 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)
- ClinicalTrials.gov ID
- NCT05330832
- Acronym / sponsor ID
- NCHPOI-2021-11
- Conditions
- Coronavirus Disease 2019
- Keywords
- COVID-19, venous thromboembolism, pulmonary embolism, myocardial infarction, ischemic stroke, atherothrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 21 Apr 2022 (estimated)
- First posted
- 15 Apr 2022 (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 aim of the study is estimating the predictive and preventative capability of thrombodynamics for severe pneumonia coagulopathy complications in patients with COVID-19 infection. Thrombodynamics test is a method for blood coagulation and anticoagulation monitoring. It could be a useful tool for predicting thrombohemorrhagic complications in patients with COVID-19 infection and developing a novel scheme of anticoagulant therapy.
Inclusion criteria are the following: patient informed concern, confirmed COVID-19 diagnosis, state of modern or critical condition.
Detailed description
The novel coronavirus viral infection (currently classified as COVID-19) causes a significant increase in death rate worldwide. Most of the patients with COVID-19 develop respiratory failure as well as coagulopathy.
The International Society of Thrombosis and Hemostasis (ISTH) has recently published guidelines for the treatment of coagulopathies in patients with COVID-19. It suggests using prophylactic doses of low molecular weight heparin (LMWH) in all patients with COVID-19. Numerous studies show a high percentage of thromboembolic complications in patients with COVID-19 as well as its potential association with pulmonary vessels microthrombosis and the development of acute respiratory distress syndrome. It is believed that COVID-19-associated coagulopathy could happen presumably due to the systemic inflammation. However, there are still no unified criteria for anticoagulant prophylaxis in such patients.
What is more, the severity of COVID-19 infection is also associated with high risk of life-threatening conditions such as sepsis and disseminated intravascular coagulation syndrome with massive uncontrolled bleeding.
According to the current clinical guidelines, coagulopathy in COVID-19 can be only registered with standard tests (prothrombin time (PT), platelet concentration and D-dimer). However, the lengthening of PT and the drop in platelet concentration are useful for the indication of the consumption stage of DIC. These changes mean that any patient remains already at risk of bleeding and the LMWH is no longer effective. The concentration of D-dimers shows the lysis of clots formed as a result of hypercoagulation, which also makes it a "delayed" marker of hypercoagulation. Thus, there are currently no reliable laboratory tools for hypercoagulation diagnostics in patients with COVID-19.
Thrombodynamics test is a global hemostasis test that allows to register the dynamics of fibrin clot formation in time and space. This test is highly sensitive to both hyper- and hypocoagulation and, at the same time, it allows to control anticoagulant therapy with heparins. The use of thrombodynamics test for the prediction of thrombohemorrhagic complications in this group of patients could be useful for individual correction of anticoagulant treatment and prevention of coagulopathy in COVID-19.
The aim of the study is estimating the predictive capability of thrombodynamics for SARS-CoV-2 associated coagulopathy in patients with severe pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed SARS-Cov-2 infection | – | Diagnostic Test: Thrombodynamics testHospitalized patients with modern or critical condition with confirmed COVID-19 infection. Patients received standard therapy for COVID-19 infection and anticoagulant prophylaxis if needed according to current temporary clinical recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of hospitalized patients with confirmed COVID-19 infection from April till December 2020 from 5 Moscow hospitals #40, 51, 23, 64 and the Troitsk hospital.
Key inclusion criteria (2 listed)
- Patient (or the health care surrogate) Informed consent
- Confirmed COVID-19 diagnosis
Key exclusion criteria (1 listed)
- 1) Patient (or the health care surrogate) refusal to participate in this study
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 |
|---|---|---|
| Thrombodynamics testThrombodynamics test is a global hemostasis test that allows to register the dynamics of fibrin clot formation in time and space. It requires whole blood samples from included patients. | Diagnostic test | Patients with confirmed SARS-Cov-2 infection |
Primary outcome
OS
Time frame: From study enrollment until the date of death from any cause, assessed up to 4 months
Outcome Measure - In-hospital mortality rate
7 secondary outcomes
Myocardial infarction
Time frame: 4 months from study enrollment
Ischemic stroke
Time frame: 4 months from study enrollment
Arterial thrombosis
Time frame: 4 months from study enrollment
Venous thromboembolism,
Time frame: 4 months from study enrollment
DVT
Time frame: 4 months from study enrollment
Percentage of patients in moderate condition with in-hospital clinical deterioration
Time frame: 4 months from study enrollment
Percentage of patients in moderate critical with in-hospital clinical deterioration
Time frame: 4 months from study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Disease 2019, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 Russia. 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?
Results are not available in the source record.
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?
OS (time frame: From study enrollment until the date of death from any cause, assessed up to 4 months). 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 15 Apr 2022.