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NCT05334615 · ClinicalTrials.gov registry record
COVID-19 Coagulopathy Extension Study
A clinical trial of COVID-19, sponsored by University of Iowa.
- Recruiting
- Registry status
- 180
- Enrollment target
- 1
- Study location
NCT05334615: Recruiting study of COVID-19, sponsored by University of Iowa.
NCT05334615 is a study of COVID-19 that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 180 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05334615, a study of COVID-19, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- 180 participants
- Enrollment target
- 1
- Study location
Study 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 c
Primary Outcome
Determine the time course of enhanced thrombin generation potential in patients with COVID-19 or influenza
Conditions Studied
Study Locations (1)
Iowa
- University of Iowa Health Care - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2025-12-31 |
What NCT05334615 shows while recruiting
NCT05334615 is an observational study that tracks outcomes without assigning an intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 0 interventions.
NCT05334615 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT05334615 about?
NCT05334615 is a clinical study titled "COVID-19 Coagulopathy Extension Study". 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 collecte...
What is the current status of trial NCT05334615?
This trial is currently recruiting. The enrollment target is 180 participants. The study started on 2022-01-21. Estimated completion is 2025-12-31.
What conditions does trial NCT05334615 study?
This clinical trial studies the following conditions: COVID-19.
Who is sponsoring clinical trial NCT05334615?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05334615 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05334615's enrollment target sits among peer trials
180 163rd of 298 higher than 136 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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