No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Study type
Observational
Participants needed
180 (estimated)
Sponsor
University of Iowa · Other
Who this trial is looking for
This trial is looking for hospitalized adults with COVID-19 or influenza. Participants will provide blood samples to help researchers understand blood clotting issues related to these infections.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have been hospitalized for COVID-19 symptoms
I have a confirmed COVID-19 infection by test within the last 4 weeks
I have been hospitalized for reasons unrelated to COVID-19 but have a positive COVID-19 test
I have been hospitalized for influenza symptoms
I have a confirmed influenza infection by test within the last 4 weeks
I have tested negative for COVID-19
You may not be able to join if
I am currently pregnant
I am a prisoner
I have a history of a bleeding disorder
I have active cancer
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.…
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.
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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 ho…
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
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