COVID Cohort Study

Stopped early

Conditions studied: COVID-19, Acute Respiratory Failure

In brief

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.

Key facts

Study ID

NCT04393155

Run by

University of Vermont

People needed

16

Starts

2020-04-16

Expected to finish

2021-01-25

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Vermont College of Medicine — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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