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COVID-19 Coagulopathy Extension Study

This observational study is looking at how COVID-19 affects blood clotting, specifically focusing on how the body generates thrombin (a key protein in blood clotting) and how blood cells are activated. Researchers previously found that people hospitalized with COVID-19 had an increased potential for thrombin generation that lasted for at least 30 days. This study aims to continue observing these effects over a longer period. You may be able to join if you are 18 to 99 years old and were hospitalized for COVID-19 with a confirmed SARS-CoV-2 infection within 4 weeks of admission. The study will measure thrombin generation, blood cell activation, and cellular mediators of thrombin generation over three years.

Study design
This is an observational study with a planned enrollment of 180 participants. It is not a randomized trial and does not involve specific interventions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years to measure primary endpoints like thrombin generation and blood cell activation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05334615

COVID-19 Coagulopathy Extension Study

Recruiting
Not specifiedAges 18–99Observational
University of Iowa
~180 participants
Updated 2025-04-06 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Thrombin generation
Measured over 3 years
+2 more outcomes measured

Conditions

COVID-19

Explore related trials

COVID-19 InfectionInfluenza

Where it's being run

1 sites across 1 states
Iowa1

Who to contact

Steven Lentz, MD, PhD
[email protected]
+1 319 356 4048
Email the study team

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Eligibility criteria

Inclusion

Hospital admission for management of symptoms related to COVID-19
Laboratory confirmed infection with SARS-CoV-2 by either PCR or antigen testing within 4 weeks of hospital admission
Age ≥18 years 2. Incidental COVID-19
Hospital admission for indications unrelated to COVID-19 who are incidentally found to have infection with SARS-CoV-2
Age ≥18 years 3. Acute influenza
Hospital admission for clinical management of symptoms related to influenza
Laboratory confirmed infection with influenza A or influenza B within 4 weeks of hospital admission
Negative testing for SARS-CoV-2
Age ≥18 years

Exclusion

Current pregnancy
Prisoner
History of a bleeding disorder
Active cancer

What this trial measures

  • Thrombin generation3 years

    Determine the time course of enhanced thrombin generation potential in patients with COVID-19 or influenza

  • Blood cell activation3 years

    Test the hypothesis that activation of platelets, neutrophils, and endothelial cells by plasma from COVID-19 patients is mediated by Gal-3, IL6, and/or histones.

  • Cellular mediators of thrombin generation3 years

    Determine the roles of neutrophils, platelets and endothelial cells in mediating increased thrombin generation and whether targeting IL6, Gal-3, or histones decreases thrombin generation potential in plasma samples from COVID-19 patients.