| NCT ID | NCT05334615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Iowa |
| Condition | COVID-19 |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-01-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-01-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria Subjects must meet all inclusion criteria in one of the following three categories: 1. 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 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 criteria * Current pregnancy * Prisoner * History of a bleeding disorder * Active cancer
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05334615 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05334615 currently recruiting?
Yes, NCT05334615 is actively recruiting participants. Contact the research team at steven-lentz@uiowa.edu for enrollment information.
Where is the NCT05334615 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT05334615 clinical trial?
NCT05334615 is sponsored by University of Iowa. The trial plans to enroll 180 participants.
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