COVID-19NCT04393155
COVID Cohort Study
An observational study of COVID-19 and Acute Respiratory Failure, run by University of Vermont at 1 site in United States.
Trial summary
The novel SARS-CoV-2 virus has quickly spread worldwide, with substantial morbidity and mortality. There is very limited understanding of the short- and longer-term inflammatory/immunological and clinical course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Respiratory Failure
- What is being tested?
- COVID-19+ observational
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2020to 25 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll patients hospitalized at participating medical centers 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 proximity of the patient to medical and research staff and UVM laboratories.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- Pregnant
- Incarcerated
- Homelessness
- Physician declines patient enrollment (attending physician or study physician)
- Patient or LAR do not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
Official title: Understanding Immunology and Patient Outcomes of COVID-19: A 1-Year Longitudinal Follow-up Study of Hospitalized Patients
The novel SARS-CoV-2 virus has quickly spread worldwide, with substantial morbidity and mortality. There is very limited understanding of the short- and longer-term inflammatory/immunological and clinical course. However, the investigators expect survivors from severe COVID-19 to experience persistent functional impairments, as demonstrated in prior studies of patients with acute respiratory distress syndrome (ARDS) and other acute viral illnesses. Notably, however, few studies have ever investigated the biologic mechanisms underlying these functional impairments. Understanding these features of COVID-19 will improve the ability to design acute therapies and recovery-focused interventions. To address these knowledge gaps, the investigators propose a two-center, 225 patient longitudinal prospective cohort study of hospitalized COVID-19 patients with acute respiratory failure. Researchers will perform an in-depth evaluation of inflammatory/immunological biomarkers, and physical, pulmonary, and neuropsychological clinical outcomes during hospitalization, and over 3-, 6-, and 12-month follow-up.
Read the detailed description
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.
- Conditions
- COVID-19, Acute Respiratory Failure
- Being tested
- COVID-19+ observational
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19+ observationalOther
This is observational -- there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| COVID-19+ | Hospitalized patients with acute respiratory failure (new oxygen requirement) due to COVID-19 Receives: Other: COVID-19+ observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk distance (6MWD)
Exercise capacity
Measured: 3 months after hospital admission
Secondary outcomes (21)
Six minute walk distance (6MWD)
Exercise capacity
Measured: 6 months, 12 months after hospital admission
Hospital Anxiety and Depression Scale (HADS)
Symptoms of anxiety and depression. Both anxiety and depression subscales are scored from 0-21, with higher scores indicating more symptoms.
Measured: 3 months, 6 months, 12 months after hospital admission
EuroQol Group standardized measure of health status (EQ-5D-5L)
Health-related quality of life. The EQ-5D-5L is scored from 0-100, with a higher score indicating better health status.
Measured: 3 months, 6 months, 12 months after hospital admission
MoCA-BLIND
Mental and Cognitive Functioning. The MoCA-BLIND is scored from 1-22, with higher scores indicating better cognitive function.
Measured: 3 months, 6 months, 12 months after hospital admission
Health Care Utilization Survey (HUS)
Health Care Utilization
Measured: 3 months, 6 months, 12 months after hospital admission
Death
Mortality
Measured: 3 months, 6 months, 12 months after hospital admission
Forced vital capacity (FVC)
The maximum volume of gas expired when the patient exhales as forcefully and rapidly as possible after a maximal inspiration. Obtained by spirometry.
Measured: 3 months, 6 months, 12 months after hospital admission
Forced expiratory volume in 1 second (FEV1)
Measure of the volume expired over the first second of an FVC maneuver. Obtained by spirometry
Measured: 3 months, 6 months, 12 months after hospital admission
4-meter timed walk
Gait speed
Measured: 3 months, 6 months, 12 months after hospital admission
Peripheral blood mononuclear cell type: CD4+ T cells (#cells/ml)
Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Peripheral blood mononuclear cell type: CD8+ T cells (#cells/ml)
Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Peripheral blood mononuclear cell type: B cells (#cells/ml)
Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Peripheral blood mononuclear cell type: NK cells (#cells/ml)
Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Peripheral blood mononuclear cell type: monocytes (#cells/ml)
Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: C-Reactive Protein (CRP) (mg/l)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Interleukin 6 (IL-6) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Interleukin 8 (IL-8) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Interferon gamma (IFNg) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Interferon alpha (IFNa) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Tumor necrosis factor alpha (TNFa) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Circulating markers of inflammation: Interleukin 1 beta (IL-1b) (pg/ml)
Biomarkers measured from plasma will be assayed using Luminex-based multiplex immunoassay.
Measured: study days 1, 3, and 7; then 3 months, 6 months, 12 months after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start16 Apr 2020
- Primary completion20 Jan 2021
- Study completion25 Jan 2021
Why it stopped: Grant application to fund this work was not funded. We won't be posting data for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393155
- Sponsor's protocol ID
- 16-540
- Status last verified
- Feb 2021
- First submitted
- 6 May 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Immunology and Patient Outcomes of COVID-19: A 1-Year Longitudinal Follow-up Study of Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04393155
- Acronym / sponsor ID
- 16-540
- Conditions
- COVID-19, Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Grant application to fund this work was not funded. We won't be posting data for this study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The novel SARS-CoV-2 virus has quickly spread worldwide, with substantial morbidity and mortality. There is very limited understanding of the short- and longer-term inflammatory/immunological and clinical course. However, the investigators expect survivors from severe COVID-19 to experience persistent functional impairments, as demonstrated in prior studies of patients with acute respiratory distress syndrome (ARDS) and other acute viral illnesses. Notably, however, few studies have ever investigated the biologic mechanisms underlying these functional impairments. Understanding these features of COVID-19 will improve the ability to design acute therapies and recovery-focused interventions. To address these knowledge gaps, the investigators propose a two-center, 225 patient longitudinal prospective cohort study of hospitalized COVID-19 patients with acute respiratory failure. Researchers will perform an in-depth evaluation of inflammatory/immunological biomarkers, and physical, pulmonary, and neuropsychological clinical outcomes during hospitalization, and over 3-, 6-, and 12-month follow-up.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19+ | – | Other: COVID-19+ observationalHospitalized patients with acute respiratory failure (new oxygen requirement) due to COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients hospitalized at participating medical centers 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 proximity of the patient to medical and research staff and UVM laboratories.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19+ observationalThis is observational -- there is no intervention | Other | COVID-19+ |
Primary outcome
Six minute walk distance (6MWD)
Time frame: 3 months after hospital admission
Exercise capacity
21 secondary outcomes
Six minute walk distance (6MWD)
Time frame: 6 months, 12 months after hospital admission
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months, 6 months, 12 months after hospital admission
EuroQol Group standardized measure of health status (EQ-5D-5L)
Time frame: 3 months, 6 months, 12 months after hospital admission
MoCA-BLIND
Time frame: 3 months, 6 months, 12 months after hospital admission
Health Care Utilization Survey (HUS)
Time frame: 3 months, 6 months, 12 months after hospital admission
Death
Time frame: 3 months, 6 months, 12 months after hospital admission
Forced vital capacity (FVC)
Time frame: 3 months, 6 months, 12 months after hospital admission
Forced expiratory volume in 1 second (FEV1)
Time frame: 3 months, 6 months, 12 months after hospital admission
4-meter timed walk
Time frame: 3 months, 6 months, 12 months after hospital admission
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study was stopped early (reason given: Grant application to fund this work was not funded. We won't be posting data for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Acute Respiratory Failure, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Grant application to fund this work was not funded. We won't be posting data for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk distance (6MWD) (time frame: 3 months after hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.