COVID-19NCT04410107

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

An observational study of COVID-19 and SARS-CoV-2 Infection, run by Federal University of Rio Grande do Sul at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: COVID-19, SARS-CoV-2 Infection
What is being tested?: Lung Function tests, Exercise capacity and Exercise physiology
How many people: 144 participants
Where: 5 sitesBrazil
Study dates: 15 May 2020to 30 Jul 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

Study population: Subjects that survived severe COVID-19

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

Universidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99052-900
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-000
Hospital de Clínicas de Porto Alegre/Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-003
Univesidade de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200

Other trials in Brazil

About this study

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

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.

Read the 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
Being tested: Lung Function tests, Exercise capacity, Exercise physiology, Health-related quality of life, Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
Keywords: Severe Acute Respiratory Syndrome Coronavirus 2, Pneumonia, Respiratory Distress Syndrome, Adult, Respiratory Function Tests, Exercise, Quality of Life
Medical subject headings: COVID-19, Pneumonia, Respiratory Distress Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lung Function testsDiagnostic 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)
Exercise capacityDiagnostic test
6-minute walk test (6MWT distance)
Exercise physiologyDiagnostic test
Cardiopulmonary exercise test (CPET)
Health-related quality of lifeDiagnostic test
Short-Form Health Survey Questionnaire (SF-36)
Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screeningDiagnostic test
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).

Study groups in NCT04410107
Study group	Role	What they receive
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. Receives: Diagnostic Test: Lung Function tests; Diagnostic Test: Exercise capacity; Diagnostic Test: Exercise physiology; Diagnostic Test: Health-related quality of life; Diagnostic Test: Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening
Acute respiratory distress syndrome (ARDS)		* Onset: acute, i.e. within 1 week of known clinical insult or new or worsening respiratory symptoms; and * Chest imaging (e.g. X-ray or CT scan): bilateral opacities, not fully explained by effusions, lobar/lung collapse or nodules; and * Origin of pulmonary edema: respiratory failure not fully explained by cardiac failure or fluid overload; and * Degree of hypoxemia: arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure ≥ 5 cm H2O. Receives: Diagnostic Test: Lung Function tests; Diagnostic Test: Exercise capacity; Diagnostic Test: Exercise physiology; Diagnostic Test: Health-related quality of life; Diagnostic Test: Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced expiratory volume in the first second/forced vital capacity
ratio obtained from measured values during spirometry
Measured: 6 months
Total lung capacity
obtained from plethysmography (% of predicted)
Measured: 6 months
Lung diffusion capacity for carbon monoxide
obtained from single-breathe maneuver (% of predicted)
Measured: 6 months
6-minute walk test distance
distance walked during the test (m)
Measured: 6 months
Short-form 36 questionnaire (SF-36)
scores range between 0 and 100 with higher scores indicating a better HRQoL
Measured: 6 months

Secondary outcomes (22)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202030 Jul 2023

First posted1 Jun 2020
Study start15 May 2020
Primary completion30 Apr 2023
Study completion30 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04410107
Sponsor's protocol ID: 2020-0169
Status last verified: Nov 2023
First submitted: 25 May 2020
Last updated: 4 Dec 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37255163

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short and Long Term Assessment of Lung Function, Exercise Capacity and Health-Related Quality of Life in Survivors of Severe COVID-19
ClinicalTrials.gov ID: NCT04410107
Acronym / sponsor ID: 2020-0169
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
Study type: Observational
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Collaborators: Hospital de Clinicas de Porto Alegre, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital Moinhos de Vento, Federal University of Health Science of Porto Alegre, Universidade de Passo Fundo, Hospital Nossa Senhora da Conceicao
Study start: 15 May 2020 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 30 Jul 2023 (actual)
First posted: 1 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Severe Pneumonia	–	Diagnostic Test: Lung Function tests, Diagnostic Test: Exercise capacity, Diagnostic Test: Exercise physiology, Diagnostic Test: Health-related quality of life, Diagnostic Test: Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screeningPresence 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)	–	Diagnostic Test: Lung Function tests, Diagnostic Test: Exercise capacity, Diagnostic Test: Exercise physiology, Diagnostic Test: Health-related quality of life, Diagnostic Test: Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening* Onset: acute, i.e. within 1 week of known clinical insult or new or worsening respiratory symptoms; and * Chest imaging (e.g. X-ray or CT scan): bilateral opacities, not fully explained by effusions, lobar/lung collapse or nodules; and * Origin of pulmonary edema: respiratory failure not fully explained by cardiac failure or fluid overload; and * Degree of hypoxemia: arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure ≥ 5 cm H2O.

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult
Study population: Subjects that survived severe COVID-19

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lung Function testsSpirometry 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	Acute respiratory distress syndrome (ARDS), Severe Pneumonia
Exercise capacity6-minute walk test (6MWT distance)	Diagnostic test	Acute respiratory distress syndrome (ARDS), Severe Pneumonia
Exercise physiologyCardiopulmonary exercise test (CPET)	Diagnostic test	Acute respiratory distress syndrome (ARDS), Severe Pneumonia
Health-related quality of lifeShort-Form Health Survey Questionnaire (SF-36)	Diagnostic test	Acute respiratory distress syndrome (ARDS), Severe Pneumonia
Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening1. 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).	Diagnostic test	Acute respiratory distress syndrome (ARDS), Severe Pneumonia

Primary outcome

Forced expiratory volume in the first second/forced vital capacity
Time frame: 6 months
ratio obtained from measured values during spirometry
Total lung capacity
Time frame: 6 months
obtained from plethysmography (% of predicted)
Lung diffusion capacity for carbon monoxide
Time frame: 6 months
obtained from single-breathe maneuver (% of predicted)
6-minute walk test distance
Time frame: 6 months
distance walked during the test (m)
Short-form 36 questionnaire (SF-36)
Time frame: 6 months
scores range between 0 and 100 with higher scores indicating a better HRQoL

22 secondary outcomes

Forced expiratory volume in the first second/forced vital capacity
Time frame: 12 and 24 months
Forced vital capacity
Time frame: 6, 12 and 24 months
Residual volume/total lung capacity
Time frame: 6, 12 and 24 months
Inspiratory capacity/total lung capacity
Time frame: 6, 12 and 24 months
Airway resistance (Raw)
Time frame: 6, 12 and 24 months
Lung diffusion capacity for carbon monoxide
Time frame: 12 and 24 months
Resistance at 20Hz and 5Hz (R5-R20)
Time frame: 6, 12 and 24 months
Reactance at 5Hz (X5)
Time frame: 6, 12 and 24 months
Resonant frequency (Fres)
Time frame: 6, 12 and 24 months
Reactance area (AХ)
Time frame: 6, 12 and 24 months
6-minute walk test distance
Time frame: 12 and 24 months
Pulse oximetry (SpO2) at rest
Time frame: 6, 12 and 24 months
Pulse oximetry (SpO2) during exercise
Time frame: 6, 12 and 24 months
Respiratory symptoms adapted from American Thoracic Society Questionnaire
Time frame: 6, 12 and 24 months
Short-form 36 questionnaire (SF-36)
Time frame: 12 and 24 months
Oxygen uptake at peak exercise
Time frame: 6, 12 and 24 months
Minute-ventilation/carbon dioxide output during exercise
Time frame: 6, 12 and 24 months
Dyspnea during exercise
Time frame: 6, 12 and 24 months
Inspiratory capacity during exercise
Time frame: 6, 12 and 24 months
Beck Anxiety Inventory (BAI)
Time frame: 6, 12 and 24 months
Beck Depression Inventory (BDI)
Time frame: 6, 12 and 24 months
Post-traumatic stress symptoms questionnaire
Time frame: 6, 12 and 24 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
Derived from this study: PubMed 37255163Benedetto 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danilo C Berton, Dr principal investigator

Universidade Federal do Rio Grande do Sul/Hospital de Clínicas de Porto Alegre

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and SARS-CoV-2 Infection, run by Federal University of Rio Grande do Sul at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced expiratory volume in the first second/forced vital capacity (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04410107, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.