Status:

TERMINATED

COVID Cohort Study

Lead Sponsor:

University of Vermont

Conditions:

COVID-19

Acute Respiratory Failure

Eligibility:

All Genders

18+ years

Brief 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 clin...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 16 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 25 2021

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT04393155

Start Date

April 16 2020

End Date

January 25 2021

Last Update

February 12 2021

Active Locations (1)

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1

University of Vermont College of Medicine

Burlington, Vermont, United States, 05405