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

NCT04410107 | Completed

• 1 other identifier: 2020-0169
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 5

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.

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

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (22)

• Forced expiratory volume in the first second/forced vital capacity

  12 and 24 months

• Forced vital capacity

  6, 12 and 24 months

• Residual volume/total lung capacity

  6, 12 and 24 months

• Inspiratory capacity/total lung capacity

  6, 12 and 24 months

• Airway resistance (Raw)

  6, 12 and 24 months

Study Arms (2)

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.

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.

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

Interventions

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)

Acute respiratory distress syndrome (ARDS); Severe Pneumonia

Exercise capacity DIAGNOSTIC_TEST

6-minute walk test (6MWT distance)

Acute respiratory distress syndrome (ARDS); Severe Pneumonia

Exercise physiology DIAGNOSTIC_TEST

Cardiopulmonary exercise test (CPET)

Acute respiratory distress syndrome (ARDS); Severe Pneumonia

Health-related quality of life DIAGNOSTIC_TEST

Short-Form Health Survey Questionnaire (SF-36)

Acute respiratory distress syndrome (ARDS); Severe Pneumonia

Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening DIAGNOSTIC_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).

Acute respiratory distress syndrome (ARDS); Severe Pneumonia

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that survived severe COVID-19

You may qualify if:

• 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.

You may not qualify if:

• Active respiratory tract infection (of any cause); or
• Any clinical condition that prevents the performance of the study procedures.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Hospital Moinhos de Vento: collaborator
• Federal University of Health Science of Porto Alegre: collaborator
• Universidade de Passo Fundo: collaborator
• Hospital Nossa Senhora da Conceicao: collaborator

Study Sites (5)

Universidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, 99052-900, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Univesidade de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37255163 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumonia; Respiratory Distress Syndrome; Motor Activity

Interventions

Respiratory Function Tests; Sports Nutritional Physiological Phenomena

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Danilo C Berton, Dr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 1, 2020
• Study Start: May 15, 2020
• Primary Completion: April 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

BR (5)