NCT04410107

Lung Function, Exercise Capacity and Health-Related Quality of Life After Severe COVID-19

Short and Long Term Assessment of Lung Function, Exercise Capacity and Health-Related Quality of Life in Survivors of Severe COVID-19

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (SARS-CoV-2) that can progress to severe disease requiring hospitalization and oxygen support in around14% of the cases and 5% require admission in intensive care unit. The medium and long-term impact in survivors of severe COVID-19 on lung function, exercise capacity and health-related quality of life remains to be determined.

Detailed description

Background: Coronavirus disease 2019 (COVID-19) is a respiratory tract infection caused by a newly emergent coronavirus (severe acute respiratory syndrome coronavirus 2; SARS-CoV-2) that was first recognized in Wuhan, China, in December 2019. Currently, this infection reached pandemic levels causing serious diseases in 14% of cases and the potential to progress to acute respiratory distress syndrome (ARDS) with the need for invasive ventilatory support and prolonged hospitalization in intensive care units (ICU). The overall lethality is 2% and the lethality of cases admitted to the ICU varies from 26 to 50%. The medium and long-term impact in survivors of severe COVID-19 on lung function, exercise capacity and health related quality of life (HRQoL) remains to be determined. Aims: To evaluate the early (Visit1: 2-6 months after acute disease) and late (Visit 2: 9-15 months and Visit 3: 18-24 months) effects of severe acute respiratory syndrome on lung function, exercise capacity, respiratory symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection. Material and methods: Prospective cohort of subjects with laboratory confirmed severe COVID-19 (respiratory rate\> 30 breaths/ min; severe respiratory distress; oxyhemoglobin saturation in room air ≤93% or pulmonary involvement\> 50% in chest images). Participants will perform spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide, respiratory system resistance by impulse oscillometry and 6-minute walk test (6MWT) after 2-6 months (Visit 1) , 9-15 months (Visit 2), and 18-24 months (Visit 3) of severe COVID-19. When abnormalities in these pulmonary function tests and/or 6MWT were detected, a cardiopulmonary exercise test will be performed. Clinical, laboratory and chest image data during the severe COVID-19 hospitalization will be obtained from medical records. The minimum sample size was estimated as 134 participants to assess at least 5 independent factors to predict lung function, HRQoL and exercise capacity at the early assessment. Notwithstanding, the investigators plan to invite to participate all survivors of severe COVID-19 admitted in hospitals of the state of Rio Grande do Sul (Brazil).

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lung Function tests	Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
DIAGNOSTIC_TEST	Exercise capacity	6-minute walk test (6MWT distance)
DIAGNOSTIC_TEST	Exercise physiology	Cardiopulmonary exercise test (CPET)
DIAGNOSTIC_TEST	Health-related quality of life	Short-Form Health Survey Questionnaire (SF-36)
DIAGNOSTIC_TEST	Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening	1. Adapted translation American Thoracic Society respiratory symptoms questionnaire; 2. Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI); 3. Questionnaire for screening for post-traumatic stress symptoms (PTSD).

Timeline

• Start date: 2020-05-15
• Primary completion: 2023-04-30
• Completion: 2023-07-30
• First posted: 2020-06-01
• Last updated: 2023-12-04

Locations

5 sites across 1 country: Brazil