Nadroparin Pharmacokinetics in Different Stages of COVID-19

COVID-19 Clinical Trial

Official title:

Nadroparin Pharmacokinetics in Different Stages of COVID-19-a Prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621915
• Other study ID #: KE 0254/23/2021
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: November 2022
• Source: Medical University of Lublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: The risk of thrombotic complications in critical COVID-19 patients remains extremely high, and multicenter trials failed to prove the survival benefit of escalated doses of low molecular weight heparins (LMWH) in this group. The aim of this study was to develop a pharmacokinetic model of LMWH (nadroparin calcium) according to different stages of COVID-19 severity. Design: The investigators performed a prospective observational study. Patients: Blood samples were obtained from 43 COVID-19 patients that received nadroparin and were treated with conventional oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation. Setting: The investigators recorded clinical, biochemical, and hemodynamic variables during 72 hours of treatment. The analyzed data comprised 782 serum nadroparin concentrations and 219 anti-factor Xa levels. The investigators conducted population nonlinear mixed-effects modeling (NONMEM) and performed Monte Carlo simulations of the probability of target attainment (PTA) for reaching 0.2-0.5 IU/ml anti-Xa levels in study groups. Interventions: None. Measurements and Main Results: The investigators successfully developed a one-compartment model to describe the population pharmacokinetics of nadroparin in different stages of COVID-19. Conclusions: Different nadroparin dosing is required for patients undergoing mechanical ventilation and ECMO to achieve the same targets as those for non-critically ill patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 15, 2022
• Est. primary completion date: February 10, 2022
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients treated in the Department of Anesthesiology and Intensive Care and the Department of Infectious Diseases of a tertiary academic hospital with confirmed SARS-CoV-2 infection with a real-time reverse transcription polymerase chain reaction (RT-PCR) or an antigen test.

Exclusion Criteria:

• Coagulation disorders at the start of the therapy.

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• COVID-19
• Hemostatic Disorders
• Mechanical Ventilation
• Nadroparin
• Thrombosis

Intervention

Drug:
• Nadroparin
Subcutaneous injection of nadroparin according to the ICU guidelines for thromboprophylaxis in ICU patients.

Locations

Country	Name	City	State
Poland	2nd Department of Anesthesiology and Critical Care, Medical University of Lublin	Lublin	Lubelskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nadroparin concentration in blood measurement	Sequential measurement every 6 hours	6 hours
Primary	Change in anti-Xa serum level	Sequential measurement every 12 hours	12 hours
Secondary	Volume of distribution of nadroparin		24 hours
Secondary	Clearance of nadroparin		24 hours
Secondary	Absorption rate of nadroparin		24 hours