COVID Cohort Study
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ClinicalTrials.gov Identifier: NCT04393155 |
Recruitment Status :
Terminated
(Grant application to fund this work was not funded. We won't be posting data for this study.)
First Posted : May 19, 2020
Last Update Posted : February 12, 2021
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Condition or disease | Intervention/treatment |
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COVID-19 Acute Respiratory Failure | Other: COVID-19+ observational |
The novel coronavirus (SARS-CoV-2) and associated COVID-19 illness has quickly spread worldwide, with substantial morbidity and mortality. Early data suggest that most patients with severe COVID-19 (i.e., experiencing acute respiratory failure (ARF) in an intensive care unit) may have cytokine release syndrome and other major effects on the innate and adaptive immune systems. However, there is limited understanding of both the inflammatory/immunological and the clinical course of COVID-19, with no robust data published beyond hospital discharge. Based on prior literature from acute viral illnesses, such as Ebola and Severe Acute Respiratory Syndrome (SARS), persistent functional impairments in COVID-19 survivors is expected. Despite the importance of these issues, very few studies have ever investigated the biological mechanisms underlying persistent functional impairments after ARF. Hence, understanding the short- and longer-term biological and clinical outcomes of patients with COVID-19, and investigating associations between inflammation and clinical outcomes is important to design acute therapies and recovery-focused interventions.
To address critical gaps in knowledge, the investigators propose a 2-center longitudinal cohort study of hospitalized COVID-19 patients via an Administrative Supplement to our existing grant (R01HL132887, MPIs Stapleton and Needham). Investigators will study COVID-19 patients with ARF who have either severe disease (requiring mechanical ventilation, non-invasive ventilation, or high flow nasal cannula oxygen support) or non-severe disease (new or increased supplemental oxygen requirement, without meeting severe criteria). Researchers will perform an in-depth evaluation of inflammatory/immunological, physical, pulmonary, and neuropsychological status during hospitalization, and over 3, 6, and 12-month follow-up. Feasibility for accomplishing this prospective study is demonstrated by 1) a successful existing collaboration between the University of Vermont (UVM) and Johns Hopkins University (JHU), supported by multiple NIH grants, and 2) the current and projected COVID-19 census at both hospital systems. The investigators have the existing infrastructure, expertise, and personnel to enroll 225 patients with COVID-19, and longitudinally follow survivors for 12 months, to investigate short-term and longer-term inflammatory/immunologic and clinical outcomes during this pandemic.
Study Type : | Observational |
Actual Enrollment : | 16 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Understanding Immunology and Patient Outcomes of COVID-19: A 1-Year Longitudinal Follow-up Study of Hospitalized Patients |
Actual Study Start Date : | April 16, 2020 |
Actual Primary Completion Date : | January 20, 2021 |
Actual Study Completion Date : | January 25, 2021 |

Group/Cohort | Intervention/treatment |
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COVID-19+
Hospitalized patients with acute respiratory failure (new oxygen requirement) due to COVID-19
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Other: COVID-19+ observational
This is observational -- there is no intervention |
- Six minute walk distance (6MWD) [ Time Frame: 3 months after hospital admission ]Exercise capacity
- Six minute walk distance (6MWD) [ Time Frame: 6 months, 12 months after hospital admission ]Exercise capacity
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Symptoms of anxiety and depression. Both anxiety and depression subscales are scored from 0-21, with higher scores indicating more symptoms.
- EuroQol Group standardized measure of health status (EQ-5D-5L) [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Health-related quality of life. The EQ-5D-5L is scored from 0-100, with a higher score indicating better health status.
- MoCA-BLIND [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Mental and Cognitive Functioning. The MoCA-BLIND is scored from 1-22, with higher scores indicating better cognitive function.
- Health Care Utilization Survey (HUS) [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Health Care Utilization
- Death [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Mortality
- Forced vital capacity (FVC) [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]The maximum volume of gas expired when the patient exhales as forcefully and rapidly as possible after a maximal inspiration. Obtained by spirometry.
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Measure of the volume expired over the first second of an FVC maneuver. Obtained by spirometry
- 4-meter timed walk [ Time Frame: 3 months, 6 months, 12 months after hospital admission ]Gait speed
- Peripheral blood mononuclear cell type: CD4+ T cells (#cells/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
- Peripheral blood mononuclear cell type: CD8+ T cells (#cells/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
- Peripheral blood mononuclear cell type: B cells (#cells/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
- Peripheral blood mononuclear cell type: NK cells (#cells/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
- Peripheral blood mononuclear cell type: monocytes (#cells/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
- Circulating markers of inflammation: C-Reactive Protein (CRP) (mg/l) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Interleukin 6 (IL-6) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Interleukin 8 (IL-8) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Interferon gamma (IFNg) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Interferon alpha (IFNa) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Tumor necrosis factor alpha (TNFa) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
- Circulating markers of inflammation: Interleukin 1 beta (IL-1b) (pg/ml) [ Time Frame: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission ]Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult (≥18 years old) at the time of consent
- Positive COVID-19 test result or highly suspicious for COVID-19 infection and have a test pending
- Acute Respiratory Failure (new requirement for supplemental oxygen or acute increase in required supplemental oxygen)
Exclusion Criteria:
- Expected death or withdrawal of life-sustaining treatments within 3 days
- Unable to walk ≥150 feet prior to COVID-19 (due to 6-minute walk test being primary outcome for in-person testing)
- Hemoglobin ≤7.0 at the time of consent
- Pre-existing cognitive/language impairment prohibiting clinical outcomes assessment
- Prior lung resection (due to spirometry as part of in-person outcome assessment)
- Unable to provide consent and no legally authorized representative (LAR) identified or reached by phone
- Pregnant
- Incarcerated
- Homelessness
- Physician declines patient enrollment (attending physician or study physician)
- Patient or LAR do not consent to participate in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393155
United States, Vermont | |
University of Vermont College of Medicine | |
Burlington, Vermont, United States, 05405 |
Responsible Party: | Renee Stapleton, Professor of Medicine, University of Vermont |
ClinicalTrials.gov Identifier: | NCT04393155 |
Other Study ID Numbers: |
16-540 |
First Posted: | May 19, 2020 Key Record Dates |
Last Update Posted: | February 12, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Insufficiency Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Respiration Disorders |