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| Name | Class |
|---|---|
| Hospital de Clinicas de Porto Alegre | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| Hospital Moinhos de Vento | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Pneumonia | Presence of fever or suspected lower respiratory infection, plus one of the following criteria: 1) respiratory rate> 30 movements / min; 2) severe respiratory distress 3) Pulse oximetry (SpO2) ≤93% in room air; and/or 3) Pulmonary infiltrates> 50% on chest imaging within 24-48hrs of symptom onset. |
| |
| Acute respiratory distress syndrome (ARDS) |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Function tests | Diagnostic Test | Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in the first second/forced vital capacity | ratio obtained from measured values during spirometry | 6 months |
| Total lung capacity | obtained from plethysmography (% of predicted) | 6 months |
| Lung diffusion capacity for carbon monoxide | obtained from single-breathe maneuver (% of predicted) | 6 months |
| 6-minute walk test distance | distance walked during the test (m) | 6 months |
| Short-form 36 questionnaire (SF-36) | scores range between 0 and 100 with higher scores indicating a better HRQoL | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in the first second/forced vital capacity | ratio obtained from measured values during spirometry | 12 and 24 months |
| Forced vital capacity | % of predicted |
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Inclusion Criteria:
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Subjects that survived severe COVID-19
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| Name | Affiliation | Role |
|---|---|---|
| Danilo C Berton, Dr | Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99052-900 | Brazil | ||
| Hospital Moinhos de Vento |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37255163 | Derived | Benedetto IG, Silva RMCD, Hetzel GM, Viana GDS, Guimaraes AR, Folador L, Brentano VB, Garcia TS, Ribeiro SP, Dalcin PTR, Gazzana MB, Berton DC. Impact of impaired pulmonary function on clinical outcomes in survivors of severe COVID-19 without pre-existing respiratory disease. J Bras Pneumol. 2023 May 26;49(3):e20220452. doi: 10.36416/1806-3756/e20220452. eCollection 2023. |
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| Federal University of Health Science of Porto Alegre |
| OTHER |
| Universidade de Passo Fundo | OTHER |
| Hospital Nossa Senhora da Conceicao | OTHER |
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| Exercise capacity | Diagnostic Test | 6-minute walk test (6MWT distance) |
|
| Exercise physiology | Diagnostic Test | Cardiopulmonary exercise test (CPET) |
|
| Health-related quality of life | Diagnostic Test | Short-Form Health Survey Questionnaire (SF-36) |
|
| Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening | Diagnostic Test |
|
|
| 6, 12 and 24 months |
| Residual volume/total lung capacity | ratio obtained from measured values during plethysmography | 6, 12 and 24 months |
| Inspiratory capacity/total lung capacity | ratio obtained from measured values during plethysmography | 6, 12 and 24 months |
| Airway resistance (Raw) | obtained from body plethysmography | 6, 12 and 24 months |
| Lung diffusion capacity for carbon monoxide | obtained from single-breathe maneuver (% of predicted) | 12 and 24 months |
| Resistance at 20Hz and 5Hz (R5-R20) | obtained from Impulse oscillometry | 6, 12 and 24 months |
| Reactance at 5Hz (X5) | obtained from Impulse oscillometry | 6, 12 and 24 months |
| Resonant frequency (Fres) | obtained from Impulse oscillometry | 6, 12 and 24 months |
| Reactance area (AХ) | obtained from Impulse oscillometry | 6, 12 and 24 months |
| 6-minute walk test distance | distance walked during the test (m) | 12 and 24 months |
| Pulse oximetry (SpO2) at rest | before 6-minute walk test | 6, 12 and 24 months |
| Pulse oximetry (SpO2) during exercise | at the end of 6-minute walk test | 6, 12 and 24 months |
| Respiratory symptoms adapted from American Thoracic Society Questionnaire | descriptive/qualitative questionnaire | 6, 12 and 24 months |
| Short-form 36 questionnaire (SF-36) | scores range between 0 and 100 with higher scores indicating a better HRQoL | 12 and 24 months |
| Oxygen uptake at peak exercise | from incremental Cardiopulmonary exercise test (% of predicted) | 6, 12 and 24 months |
| Minute-ventilation/carbon dioxide output during exercise | from incremental Cardiopulmonary exercise test (L/L) | 6, 12 and 24 months |
| Dyspnea during exercise | from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale) | 6, 12 and 24 months |
| Inspiratory capacity during exercise | from incremental Cardiopulmonary exercise test (L and % of predicted) | 6, 12 and 24 months |
| Beck Anxiety Inventory (BAI) | total score ranges from 0 to 63; higher score indicating higher anxiety | 6, 12 and 24 months |
| Beck Depression Inventory (BDI) | total scores ranges from 0 to 63; higher score is worse | 6, 12 and 24 months |
| Post-traumatic stress symptoms questionnaire | 17-item, 5 likert-scale each item; higher score indicating more symptoms | 6, 12 and 24 months |
| Porto Alegre |
| Rio Grande do Sul |
| 90035-000 |
| Brazil |
| Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Univesidade de Ciências da Saúde de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Hospital Nossa Senhora da Conceição | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| D012128 | Respiratory Distress Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D064133 | Sports Nutritional Physiological Phenomena |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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