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Grant application to fund this work was not funded. We won't be posting data for this study.
Sponsor study identifier
observational
16
1 country
1
Study Start
February 3, 2021
Actual (reported)Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)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 study T and B cells, antibody repertoire, and durability of protective immunity, and also to quantify platelet expression of FcγRIIa and circulating EMPs, as described in the protocol.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2021
Actual (reported)February 9, 2021
Actual (reported)May 19, 2021
Actual (reported)June 30, 2023
Actual (reported)June 30, 2023
Actual (reported)To compare the polyfunctionality and frequency of antiviral CD4 and CD8 T cells.
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.
Four weeks (while hospitalized)
To compare the polyfunctionality and frequency of antiviral CD4 and CD8 T cells.
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.
12 months after hospital admission
To compare the frequency of plasmablasts (early B cells that produce antiviral antibodies) and plasma antiviral antibody titer during acute infection.
The investigators predict that patients with severe disease will have greater numbers of antiviral plasmablasts and plasma antiviral antibody levels compared to those with mild disease.
Four weeks (while hospitalized)
To compare the frequency of plasmablasts (early B cells that produce antiviral antibodies) and plasma antiviral antibody titer during acute infection.
The investigators predict that patients with severe disease will have greater numbers of antiviral plasmablasts and plasma antiviral antibody levels compared to those with mild disease.
12 months after hospital admission
The number of virus specific CD4 T cells will be measured using flow cytometry.
The investigators hypothesize that severe disease will result in the formation of higher magnitude antiviral B and T cell CHRMS (Medical) #STUDY00001369 Approved: 1/25/2021 4Human subjects protocol form 7/19/19responses during acute disease due to increased viral load and antigen in these patients. The investigators further predict that higher frequency T and B cells during acute disease will correlate with more robust durability of these responses during convalescence.
Four weeks (while hospitalized)
The number of virus specific CD8 T cells will be measured using flow cytometry.
The investigators hypothesize that severe disease will result in the formation of higher magnitude antiviral B and T cell CHRMS (Medical) #STUDY00001369 Approved: 1/25/2021 4Human subjects protocol form 7/19/19responses during acute disease due to increased viral load and antigen in these patients. The investigators further predict that higher frequency T and B cells during acute disease will correlate with more robust durability of these responses during convalescence.
Four weeks (while hospitalized)
The number of virus specific CD4 T cells will be measured using flow cytometry.
The investigators hypothesize that severe disease will result in the formation of higher magnitude antiviral B and T cell CHRMS (Medical) #STUDY00001369 Approved: 1/25/2021 4 Human subjects protocol form 7/19/19 responses during acute disease due to increased viral load and antigen in these patients. The investigators further predict that higher frequency T and B cells during acute disease will correlate with more robust durability of these responses during convalescence.
12 months after hospital admission
The number of virus specific CD8 T cells will be measured using flow cytometry.
The investigators hypothesize that severe disease will result in the formation of higher magnitude antiviral B and T cell CHRMS (Medical) #STUDY00001369 Approved: 1/25/2021 4Human subjects protocol form 7/19/19responses during acute disease due to increased viral load and antigen in these patients. The investigators further predict that higher frequency T and B cells during acute disease will correlate with more robust durability of these responses during convalescence.
12 months after hospital admission
To obtain preliminary data on platelet activation in patients hospitalized with COVID-19
To compare platelet activation, measured by platelet surface FcγRIIa while in hospital and 12 months after infection, in patients with severe (i.e., mechanical ventilation in ICU) vs. non-severe (hospitalized, but not in an ICU) COVID-19 disease.
Four weeks (while hospitalized)
To obtain preliminary data on platelet activation in patients hospitalized with COVID-19
To compare platelet activation, measured by platelet surface FcγRIIa while in hospital and 12 months after infection, in patients with severe (i.e., mechanical ventilation in ICU) vs. non-severe (hospitalized, but not in an ICU) COVID-19 disease.
12 months after hospital admission
To obtain preliminary data on endothelial activation in patients hospitalized with COVID-19
To compare endothelial activation, measured by circulating EMPs while in hospital and 12 months after infection, in patients with severe (i.e., mechanical ventilation in ICU) vs. non-severe (hospitalized, but not in an ICU) COVID-19 disease.
Four weeks (while hospitalized)
To obtain preliminary data on endothelial activation in patients hospitalized with COVID-19
To compare endothelial activation, measured by circulating EMPs while in hospital and 12 months after infection, in patients with severe (i.e., mechanical ventilation in ICU) vs. non-severe (hospitalized, but not in an ICU) COVID-19 disease.
12 months after hospital admission
Preliminarily determine if the FcγRIIa and EMPs have utility as biomarkers
To preliminarily determine if the FcγRIIa and EMPs have utility as biomarkers for prediction of thrombotic events and clinical deterioration in hospitalized patients with COVID-19.
Four weeks (while hospitalized)
Preliminarily determine if the FcγRIIa and EMPs have utility as biomarkers
To preliminarily determine if the FcγRIIa and EMPs have utility as biomarkers for prediction of thrombotic events and clinical deterioration in hospitalized patients with COVID-19.
12 months after hospital admission
Hospitalized patients with Covid-19 infection confirmed by PCR test
This is observational--there is no intervention
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This study will enroll patients hospitalized at the University of Vermont Medical Center who have a positive test result for COVID-19. These patients are expected to have a greater acuity of illness and burden of disease based on the fact that they require inpatient care. Enrolling hospitalized patients ensures a greater opportunity to collect serial biological specimens over the course of the illness due to the proximity of the patient to medical and research staff and UVM laboratories.
University of Vermont
Burlington, Vermont, 05405, United States
blood, nasal swabs
Renee Stapleton, MD, PhD
University of Vermont
16 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2021
First Posted
May 19, 2021
Study Start
February 3, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Actual (reported)Study Completion
June 30, 2023
Actual (reported)Last Updated
May 14, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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