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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410107
• Other study ID #: 2020-0169
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: November 2023
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 30, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Previous laboratory confirmation of SARS-Cov-2 infection defined as a positive result of reverse polymerase-transcriptase chain reaction test in real-time of a sample taken by nasal and/or pharyngeal swab; and

• Severe pneumonia defined by the presence of fever or suspected lower respiratory infection, plus one of the following criteria: respiratory rate> 30 movements/min; severe respiratory distress; SpO2=93% in room air; or pulmonary infiltrates>50% on chest imaging within 24-48hrs of acute symptoms onset; and/or

• Acute respiratory distress syndrome (ARDS) defined according to COVID-19 operational management guide of World Health Organization and classified as mild (200 mmHg <PaO2 / FiO2 = 300 mmHg), moderate (100 mmHg <PaO2 / FiO2 = 200 mmHg) or severe (PaO2 / FiO2 = 100 mmHg). When the PaO2 is not available, SpO2 / FiO2 = 315 suggests ARDS.

Exclusion Criteria:

• Lack of clinical stability for 2 months before inclusion (including those who remain hospitalized);

• Active respiratory tract infection (of any cause); or

• Any clinical condition that prevents the performance of the study procedures.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

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)
• Exercise capacity
6-minute walk test (6MWT distance)
• Exercise physiology
Cardiopulmonary exercise test (CPET)
• Health-related quality of life
Short-Form Health Survey Questionnaire (SF-36)
• Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
Adapted translation American Thoracic Society respiratory symptoms questionnaire; Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI); Questionnaire for screening for post-traumatic stress symptoms (PTSD).

Locations

Country	Name	City	State
Brazil	Universidade de Passo Fundo	Passo Fundo	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Nossa Senhora da Conceição	Porto Alegre	Rio Grande Do Sul
Brazil	Univesidade de Ciências da Saúde de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (7)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Health Science of Porto Alegre, Hospital de Clinicas de Porto Alegre, Hospital Moinhos de Vento, Hospital Nossa Senhora da Conceicao, Universidade de Passo Fundo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in the first second/forced vital capacity	ratio obtained from measured values during spirometry	6 months
Primary	Total lung capacity	obtained from plethysmography (% of predicted)	6 months
Primary	Lung diffusion capacity for carbon monoxide	obtained from single-breathe maneuver (% of predicted)	6 months
Primary	6-minute walk test distance	distance walked during the test (m)	6 months
Primary	Short-form 36 questionnaire (SF-36)	scores range between 0 and 100 with higher scores indicating a better HRQoL	6 months
Secondary	Forced expiratory volume in the first second/forced vital capacity	ratio obtained from measured values during spirometry	12 and 24 months
Secondary	Forced vital capacity	% of predicted	6, 12 and 24 months
Secondary	Residual volume/total lung capacity	ratio obtained from measured values during plethysmography	6, 12 and 24 months
Secondary	Inspiratory capacity/total lung capacity	ratio obtained from measured values during plethysmography	6, 12 and 24 months
Secondary	Airway resistance (Raw)	obtained from body plethysmography	6, 12 and 24 months
Secondary	Lung diffusion capacity for carbon monoxide	obtained from single-breathe maneuver (% of predicted)	12 and 24 months
Secondary	Resistance at 20Hz and 5Hz (R5-R20)	obtained from Impulse oscillometry	6, 12 and 24 months
Secondary	Reactance at 5Hz (X5)	obtained from Impulse oscillometry	6, 12 and 24 months
Secondary	Resonant frequency (Fres)	obtained from Impulse oscillometry	6, 12 and 24 months
Secondary	Reactance area (A?)	obtained from Impulse oscillometry	6, 12 and 24 months
Secondary	6-minute walk test distance	distance walked during the test (m)	12 and 24 months
Secondary	Pulse oximetry (SpO2) at rest	before 6-minute walk test	6, 12 and 24 months
Secondary	Pulse oximetry (SpO2) during exercise	at the end of 6-minute walk test	6, 12 and 24 months
Secondary	Respiratory symptoms adapted from American Thoracic Society Questionnaire	descriptive/qualitative questionnaire	6, 12 and 24 months
Secondary	Short-form 36 questionnaire (SF-36)	scores range between 0 and 100 with higher scores indicating a better HRQoL	12 and 24 months
Secondary	Oxygen uptake at peak exercise	from incremental Cardiopulmonary exercise test (% of predicted)	6, 12 and 24 months
Secondary	Minute-ventilation/carbon dioxide output during exercise	from incremental Cardiopulmonary exercise test (L/L)	6, 12 and 24 months
Secondary	Dyspnea during exercise	from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale)	6, 12 and 24 months
Secondary	Inspiratory capacity during exercise	from incremental Cardiopulmonary exercise test (L and % of predicted)	6, 12 and 24 months
Secondary	Beck Anxiety Inventory (BAI)	total score ranges from 0 to 63; higher score indicating higher anxiety	6, 12 and 24 months
Secondary	Beck Depression Inventory (BDI)	total scores ranges from 0 to 63; higher score is worse	6, 12 and 24 months
Secondary	Post-traumatic stress symptoms questionnaire	17-item, 5 likert-scale each item; higher score indicating more symptoms	6, 12 and 24 months