NCT05334615 · University of Iowa
COVID-19 Coagulopathy Extension Study
What this study is about
At the University of Iowa, the investigators led a conducted at multiple hospitals randomly assigned clinical trial comparing standard prophylactic dose to intermediate dose enoxaparin in hospitalized patients with COVID-19 (NCT04360824).
View original scientific description
At the University of Iowa, the investigators led a multicenter randomized clinical trial comparing standard prophylactic dose to intermediate dose enoxaparin in hospitalized patients with COVID-19 (NCT04360824). As part of an exploratory biomarker component of this trial, blood samples were collected from hospitalized COVID-19 patients at enrollment and weekly for up to 30 days of hospitalization. The pilot results, as well as reports from other groups, demonstrate increased potential for thrombin generation in the plasma of COVID-19 patients. In particular, in the COVID-19 patient cohort enhanced thrombin generation potential persisted for at least 30 days of hospitalization. The investigators now propose to explore the mechanistic roles of activation of blood cells (such as platelets and neutrophils) and products of cellular activation as mediators of enhanced thrombin generation in patients with COVID-19. The study design will be a longitudinal cohort study, which will allow for the determination of the time course of enhanced thrombin generation potential in relation to clinical outcomes and changes in markers of cellular activation in serial samples obtained from COVID-19 patients for up to 3 years after infection with SARS-CoV-2. This study may provide clues to why a subset of COVID-19 patients present with late thrombotic complications even after apparent recovery from SARS-CoV-2 infection. An ongoing question in the field relates to the comparative prothrombotic effects of acute COVID-19 versus incidental SARS-CoV-2 infection versus acute infection with influenza viruses. Therefore, we will include three categories of hospitalized patients in this study: (1) acute COVID-19, (2) incidental COVID-19, and (3) acute influenza A or B. This project has a strong scientific rationale with direct clinical implications, especially given the emergence of SARS-CoV-2 variants such as delta and omicron that may prolong the pandemic and/or cause surges of COVID-19 in the coming months.
Primary outcome measures
Thrombin generation
Time frame: 3 years
Determine the time course of enhanced thrombin generation potential in patients with COVID-19 or influenza
Blood cell activation
Time frame: 3 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 generation
Time frame: 3 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must meet all inclusion criteria in one of the following three categories:
- Acute COVID-19
- 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
- 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
- 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 criteria
- Current pregnancy
- History of a bleeding disorder
- Active cancer
Where
- Iowa City, Iowa
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2025 · Source of record for eligibility and locations