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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronavirus Disease 2019
• Intervention / Treatment: Diagnostic test: Thrombodynamics test

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 Type: Observational
• Enrollment (Actual): 2200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Thrombodynamics 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	Percentage of patients with in-hospital myocardial infarction	4 months from study enrollment
Ischemic stroke	Percentage of patients with in-hospital ischemic stroke	4 months from study enrollment
Arterial thrombosis	Percentage of patients with in-hospital arterial thrombosis	4 months from study enrollment
Venous thromboembolism,	Percentage of patients with in-hospital venous thromboembolism	4 months from study enrollment
DVT	Percentage of patients with in-hospital disseminated intravascular coagulation	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)	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)	4 months from study enrollment

Collaborators and Investigators

• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ANTICIPATED): April 21, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (ACTUAL): April 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; myocardial infarction; ischemic stroke; venous thromboembolism; pulmonary embolism; atherothrombosis
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: NCHPOI-2021-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No