COVID Cohort Study

NCT04393155 | Terminated

• 1 other identifier: 16-540
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COVID-19; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Six minute walk distance (6MWD)

  Exercise capacity

  3 months after hospital admission

Secondary Outcomes (21)

• Six minute walk distance (6MWD)

  6 months, 12 months after hospital admission

• Hospital Anxiety and Depression Scale (HADS)

  3 months, 6 months, 12 months after hospital admission

• EuroQol Group standardized measure of health status (EQ-5D-5L)

  3 months, 6 months, 12 months after hospital admission

• MoCA-BLIND

  3 months, 6 months, 12 months after hospital admission

• Health Care Utilization Survey (HUS)

  3 months, 6 months, 12 months after hospital admission

Study Arms (1)

COVID-19+

Hospitalized patients with acute respiratory failure (new oxygen requirement) due to COVID-19

Other: COVID-19+ observational

Interventions

COVID-19+ observational OTHER

This is observational -- there is no intervention

COVID-19+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 19, 2020
• Study Start: April 16, 2020
• Primary Completion: January 20, 2021
• Study Completion: January 25, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

US (1)