COVID Cohort Study
COVID Cohort Study
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.
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.
Inclusion Criteria:

 1. Adult (≥18 years old) at the time of consent

 2. Positive COVID-19 test result or highly suspicious for COVID-19 infection and have a
 test pending

 3. Acute Respiratory Failure (new requirement for supplemental oxygen or acute increase
 in required supplemental oxygen)

 Exclusion Criteria:

 1. Expected death or withdrawal of life-sustaining treatments within 3 days

 2. Unable to walk ≥150 feet prior to COVID-19 (due to 6-minute walk test being primary
 outcome for in-person testing)

 3. Hemoglobin ≤7.0 at the time of consent

 4. Pre-existing cognitive/language impairment prohibiting clinical outcomes assessment

 5. Prior lung resection (due to spirometry as part of in-person outcome assessment)

 6. Unable to provide consent and no legally authorized representative (LAR) identified or
 reached by phone

 7. Pregnant

 8. Incarcerated

 9. Homelessness

 10. Physician declines patient enrollment (attending physician or study physician)

 11. Patient or LAR do not consent to participate in the study