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NCT Number: NCT05143567

Hemostasis and Inflammation in COVID-19 Patients With Venous and Arterial Thrombotic Complications

The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.

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Key information

Conditions

Venous Thromboembolism COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Covid19 Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboembolism Thrombosis Vascular Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryazan State Medical University

Ryazan, 390026, Russia

About this study

The study is aimed at assessing the role of the activity of high-risk markers for thrombotic events (monocytic chemoattractant protein 1 (MCP-1), macrophage inflammatory protein 1α (MIP1α), interferon-induced gamma protein-10 (IP-10), platelet apoptosis markers (phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.

The study will include 150 patients of similar age, gender, and ethnicity, and they will be divided into three groups: Group I: 50 patients with confirmed coronavirus infection without thrombotic complications; Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography without the use of pharmacomechanical prophylaxis of VTE; Group III: 50 patients with confirmed coronavirus infection with ultrasound-confirmed thrombosis of the deep and saphenous veins of the lower extremities using pharmacomechanical prophylaxis of VTE

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • men or women over 18 years of age with a new coronavirus infection, confirmed by polymerase chain reaction (PCR) studies and chest CT.

Exclusion criteria

  • men or women under 18 years of age; active cancer or a remission period of less than 5 years; decompensated somatic pathology; pregnancy or breastfeeding in women.

Treatment and study plan

standard of care anticoagulation in absence of thrombotic complications

Other

Subgroup IA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IB - patients receive LMWH (enoxaparin) for the prevention or treatment of VTE Subgroup IC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE

standard of care anticoagulation in presence of thrombotic complications

Other

Subgroup IIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) for the prevention or treatment of VTE Subgroup IIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) for the prevention or treatment of VTE Subgroup IIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) for the prevention or treatment of VTE

standard of care anticoagulation in combination with elastic compression

Other

Subgroup IIIA - patients receive UFH (heparin, 7500 Units 2-3 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIB - patients receive LMWH (enoxaparin, 0.4ml 2 times daily) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE Subgroup IIIC - patients receive oral anticoagulants (rivaroxaban 10mg QD) in combination with class II elastic compression (compression stockings above the level of the knee) for the prevention or treatment of VTE

Primary outcomes

  1. mortality

    Time frame: one year

    lethal outcomes

  2. venous thrombosis or pulmonary embolism

    Time frame: one year

    a VTE event

  3. arterial thrombosis

    Time frame: one year

    thrombosis of main arteries of the extremities or myocardial infarction or stroke

Sponsors and collaborators

Lead sponsor

Ryazan State Medical University

Other

Registry information

Official study title

Comprehensive Assessment of the Hemostasis and Inflammation in Patients With Venous and Arterial Thrombotic Complications in Treatment of New Coronaviral Infection (COVID-19)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 3, 2021
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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