Covid-19 Associated Coagulopathy Predicted by Thrombodynamic Markers (CoViTro-I)

• Conditions: Coronavirus Disease 2019
• Interventions: Diagnostic Test: Thrombodynamics test

• Registration Number: NCT05330832
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Brief 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. 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 Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-12-15
• Status Verified: 2022-01
• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-04-14
• Last Update Submitted: 2022-04-14
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Study Completion: 2022-04-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

1. Patient (or the health care surrogate) Informed consent
2. Confirmed COVID-19 diagnosis

Exclusion Criteria

1. Patient (or the health care surrogate) refusal to participate in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with confirmed SARS-Cov-2 infection	Thrombodynamics test	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.

Primary Outcome Measures

Name	Time	Method
OS	From study enrollment until the date of death from any cause, assessed up to 4 months	Outcome Measure - In-hospital mortality rate

Secondary Outcome Measures

Name	Time	Method
DVT	4 months from study enrollment	Percentage of patients with in-hospital disseminated intravascular coagulation
Ischemic stroke	4 months from study enrollment	Percentage of patients with in-hospital ischemic stroke
Arterial thrombosis	4 months from study enrollment	Percentage of patients with in-hospital arterial thrombosis
Percentage of patients in moderate condition with in-hospital clinical deterioration	4 months from study enrollment	(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)
Venous thromboembolism,	4 months from study enrollment	Percentage of patients with in-hospital venous thromboembolism
Percentage of patients in moderate critical with in-hospital clinical deterioration	4 months from study enrollment	(respiratory support necessity, unstable hemodynamics, multiple-organ-failure syndrome, qSOFA score \> 2, arterial blood lactate \> 2 mmol)
Myocardial infarction	4 months from study enrollment	Percentage of patients with in-hospital myocardial infarction

Trial Locations

Locations (1)

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation