Actively Recruiting
COVID-19 Coagulopathy Extension Study
Led by University of Iowa · Updated on 2025-04-06
180
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
U
University of Iowa
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COVID-19 Coagulopathy Extension Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospital admission for symptoms related to acute COVID-19 with laboratory-confirmed SARS-CoV-2 infection within 4 weeks
- Age 18 years or older for acute COVID-19 patients
- Hospital admission for reasons unrelated to COVID-19 but incidentally found to have SARS-CoV-2 infection
- Age 18 years or older for incidental COVID-19 patients
- Hospital admission for symptoms related to influenza A or B with laboratory-confirmed infection within 4 weeks
- Negative SARS-CoV-2 test for acute influenza patients
- Age 18 years or older for acute influenza patients
You will not qualify if you...
- Current pregnancy
- Prisoner status
- History of bleeding disorder
- Active cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
S
Steven Lentz, MD, PhD
CONTACT
G
Gokul Patil, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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