Covid 19 Clinical Trials

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.

NCT04393155 COVID-19 Acute Respiratory Failure Other: COVID-19+ observational

MeSH:Respiratory Insufficiency Respiratory Distress Syndrome, Adult

Primary Outcomes

Description: Exercise capacity

Measure: Six minute walk distance (6MWD)

Time: 3 months after hospital admission

Secondary Outcomes

Description: Exercise capacity

Measure: Six minute walk distance (6MWD)

Time: 6 months, 12 months after hospital admission

Description: Symptoms of anxiety and depression. Both anxiety and depression subscales are scored from 0-21, with higher scores indicating more symptoms.

Measure: Hospital Anxiety and Depression Scale (HADS)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Health-related quality of life. The EQ-5D-5L is scored from 0-100, with a higher score indicating better health status.

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

Time: 3 months, 6 months, 12 months after hospital admission

Description: Mental and Cognitive Functioning. The MoCA-BLIND is scored from 1-22, with higher scores indicating better cognitive function.

Measure: MoCA-BLIND

Time: 3 months, 6 months, 12 months after hospital admission

Description: Health Care Utilization

Measure: Health Care Utilization Survey (HUS)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Mortality

Measure: Death

Time: 3 months, 6 months, 12 months after hospital admission

Description: The maximum volume of gas expired when the patient exhales as forcefully and rapidly as possible after a maximal inspiration. Obtained by spirometry.

Measure: Forced vital capacity (FVC)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Measure of the volume expired over the first second of an FVC maneuver. Obtained by spirometry

Measure: Forced expiratory volume in 1 second (FEV1)

Time: 3 months, 6 months, 12 months after hospital admission

Description: Gait speed

Measure: 4-meter timed walk

Time: 3 months, 6 months, 12 months after hospital admission

Description: Measured by cell staining and flow cytometry. PBMC differentiation/ activation/exhaustion status will be determined by multicolor flow cytometry staining with human monoclonal antibodies.

Measure: Peripheral blood mononuclear cell type: CD4+ T cells (#cells/ml)