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NCT04892797 · ClinicalTrials.gov registry record
Understanding Immunology and Patient Outcomes of COVID-19 in Hospitalized Patients
A clinical trial, sponsored by University of Vermont.
- Terminated
- Registry status
- 16
- Enrollment target
NCT04892797: Clinical Trial study, sponsored by University of Vermont.
NCT04892797 is a clinical trial that was terminated before completion, run by University of Vermont. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04892797 was terminated before completion, sponsored by University of Vermont.
- TERMINATED
- Registry status
- 16 participants
- Enrollment target
Study Summary
The adaptive immune response, consisting of antiviral T and B cells, is critical for providing protection against viruses such as SARS-CoV-2, both during an active infection and later following a subsequent exposure. They can both also potentially contribute to pathogenesis if they are overstimulated. Despite these advances in knowledge, there are still significant gaps in understanding of what constitutes a protective or immunopathologic immune response and its durability. Significant knowledge gaps also remain pertaining to the early recognition of COVID patients with increased risk of clinical deterioration who require continued hospitalization and the use of more intensive treatments designed to improve outcomes. Data from non-COVID patients with MI show that platelet surface expression of FcγRIIa, the low-affinity receptor for the Fc fragment of immunoglobulin (Ig) G, identifies patients at high and low risk of subsequent cardiovascular events. Platelet expression of FcγRIIa is increased by interferon γ20 that is significantly elevated in severe COVID-19 infections. The high prevalence of arterial thrombosis among COVID-19 patients and the central role of thrombosis in respiratory failure support the hypothesis that elevated platelet expression of FcγRIIa will identify COVID patients at increased risk of thrombotic complications and clinical deterioration. In addition to the potential role of platelet activation in thrombosis associated with COIVD-19, the endothelium may also play a significant role. The investigators hypothesize that elevated EMPs in plasma will identify patients at high risk of thrombosis and clinical deterioration. To begin to address the knowledge gaps above and obtain preliminary data for future large grant submission, the investigators propose a small, prospective, single-center cohort study that will enroll patients hospitalized for COVID-19 infection and exhibiting a range of disease severity. Biosamples will be obtained and used to
Primary Outcome
The investigators hypothesize patients with severe disease will have higher frequencies of antiviral T cells that contribute to the cytokine storm observed in the most severe cases of COVID-19.
Interventions
- OTHER Covid-19+ observational
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2023-06-30 |
Why NCT04892797 stopped before completion
NCT04892797 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Covid-19+ observational is the first listed.
NCT04892797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04892797 about?
NCT04892797 is a clinical study titled "Understanding Immunology and Patient Outcomes of COVID-19 in Hospitalized Patients". The adaptive immune response, consisting of antiviral T and B cells, is critical for providing protection against viruses such as SARS-CoV-2, both during an active infection and later following a subsequent exposure. They can both also potentially contribute to pathogenesis if they are overstimulate...
What is the current status of trial NCT04892797?
This trial is currently terminated. The enrollment target is 16 participants. The study started on 2021-02-03. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT04892797?
The interventions under investigation include: Covid-19+ observational (OTHER).
Who is sponsoring clinical trial NCT04892797?
This trial is sponsored by University of Vermont, which has 162 total clinical trials registered on ClinicalTrials.gov.
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