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

NCT05143567 | Completed

• 1 other identifier: 11.10.2021
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism; covid19; Thrombosis

Keywords

venous thromboembolism; VTE; thrombotic events; coronavirus; COVID-19; hemostasis; platelet function

Outcome Measures

Primary Outcomes (3)

• mortality

  lethal outcomes

  one year

• venous thrombosis or pulmonary embolism

  a VTE event

  one year

• arterial thrombosis

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

  one year

Study Arms (3)

patients with COVID-19 without thrombotic complications

EXPERIMENTAL

Group I: 50 patients with confirmed coronavirus infection without thrombotic complications

Other: standard of care anticoagulation in absence of thrombotic complications

patients with COVID-19 and VTE who received pharmacological prophylaxis of VTE

EXPERIMENTAL

Group II: 50 patients with confirmed coronavirus infection with thrombotic complications confirmed by ultrasonography with pharmacological prophylaxis of VTE

Other: standard of care anticoagulation in presence of thrombotic complications

patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE

EXPERIMENTAL

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.

Other: standard of care anticoagulation in combination with elastic compression

Interventions

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

patients with COVID-19 without thrombotic complications

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

patients with COVID-19 and VTE who received pharmacological prophylaxis 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

patients with COVID-19 and VTE who received pharmacomechanical prophylaxis of VTE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ryazan State Medical University: lead

Study Sites (1)

Ryazan State Medical University

Ryazan, 390026, Russia

Location

MeSH Terms

Conditions

Venous Thromboembolism; COVID-19; Thrombosis; Coronavirus Infections

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Igor Suchkov, MD, PhD

  Ryazan State Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral researcher

Model Details: Open-label cohort longitudinal study

Study Record Dates

• First Submitted: November 20, 2021
• First Posted: December 3, 2021
• Study Start: November 1, 2021
• Primary Completion: July 23, 2023
• Study Completion: July 23, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)