Clinical trial NCT04410107: Lung Function, Exercise Capacity and Health-Related Quality of Life After Severe COVID-19
Official title: Short and Long Term Assessment of Lung Function, Exercise Capacity and Health-Related Quality of Life in Survivors of Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: Severe Acute Respiratory Syndrome Coronavirus 2
Pneumonia
Respiratory Distress Syndrome, Adult
Respiratory Function Tests
Exercise
Quality of Life
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Hospital Moinhos de Vento
name: Federal University of Health Science of Porto Alegre
name: Universidade de Passo Fundo
name: Hospital Nossa Senhora da Conceicao
First posted: 2020-06-01
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects that survived severe COVID-19

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Forced expiratory volume in the first second/forced vital capacity
timeFrame: 6 months
measure: Total lung capacity
timeFrame: 6 months
measure: Lung diffusion capacity for carbon monoxide
timeFrame: 6 months
measure: 6-minute walk test distance
timeFrame: 6 months
measure: Short-form 36 questionnaire (SF-36)
timeFrame: 6 months
Secondary outcomes:
measure: Forced expiratory volume in the first second/forced vital capacity
timeFrame: 12 and 24 months
measure: Forced vital capacity
timeFrame: 6, 12 and 24 months
measure: Residual volume/total lung capacity
timeFrame: 6, 12 and 24 months
measure: Inspiratory capacity/total lung capacity
timeFrame: 6, 12 and 24 months
measure: Airway resistance (Raw)
timeFrame: 6, 12 and 24 months
measure: Lung diffusion capacity for carbon monoxide
timeFrame: 12 and 24 months
measure: Resistance at 20Hz and 5Hz (R5-R20)
timeFrame: 6, 12 and 24 months
measure: Reactance at 5Hz (X5)
timeFrame: 6, 12 and 24 months
measure: Resonant frequency (Fres)
timeFrame: 6, 12 and 24 months
measure: Reactance area (AХ)
timeFrame: 6, 12 and 24 months
measure: 6-minute walk test distance
timeFrame: 12 and 24 months
measure: Pulse oximetry (SpO2) at rest
timeFrame: 6, 12 and 24 months
measure: Pulse oximetry (SpO2) during exercise
timeFrame: 6, 12 and 24 months
measure: Respiratory symptoms adapted from American Thoracic Society Questionnaire
timeFrame: 6, 12 and 24 months
measure: Short-form 36 questionnaire (SF-36)
timeFrame: 12 and 24 months
measure: Oxygen uptake at peak exercise
timeFrame: 6, 12 and 24 months
measure: Minute-ventilation/carbon dioxide output during exercise
timeFrame: 6, 12 and 24 months
measure: Dyspnea during exercise
timeFrame: 6, 12 and 24 months
measure: Inspiratory capacity during exercise
timeFrame: 6, 12 and 24 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: 6, 12 and 24 months
measure: Beck Depression Inventory (BDI)
timeFrame: 6, 12 and 24 months
measure: Post-traumatic stress symptoms questionnaire
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Universidade de Passo Fundo
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Univesidade de Ciências da Saúde de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
state: Rio Grande Do Sul
Study officials:
affiliation: Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre
name: Danilo C Berton, Dr
role: PRINCIPAL_INVESTIGATOR
References: