Cellular Effects of SARS-CoV-2 in Mediating Thrombotic Susceptibility
University of Iowa
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.
Description
1. Background and scientific rationale Infection with the novel coronavirus SARS-CoV-2, first identified in Wuhan, China in late 2019, has become a global pandemic affecting over 209 countries and territories. The illness caused by SARS-CoV-2 is classified as COVID-19. As of August 23rd, 2021, more than 212 million cases of COVID-19 had been reported in more than 220 countries, resulting in more than 4.4 million deaths. The U.S. has by far the largest number of total cases (\>38 million) with a mortality rate of 1.67%. Although many patients may have only mild upper respiratory symptoms, some…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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 influen…
Location
- University of Iowa Health CareIowa City, Iowa