Covid19
Conditions
Keywords
Covid19, lung functions, cardiopulmonary exercise testing, thoracic CT, 6 minute walking test, Short form 36 questionnaire
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 multiorgan disease requiring hospitalization. The medium and long-term impact in survivors of COVID-19 on lung function, imaging by thoracic CT, exercise capacity, and health-related quality of life and the relation of these parameters remains to be determined.
Detailed description
Aim: To evaluate medium to late (visit 1: 6-12 months after hospital discharge) effects of COVID-19 on lung function, exercise capacity, thoracic CT findings, symptoms and HRQoL in patients with confirmed diagnosis of SARS-CoV-2 infection and the relation between these parameters. Material and methods: Prospective cohort of subjects with laboratory and/or thoracic CT confirmed COVID-19 who were treated as inpatients. Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT) and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records. The minimum sample size was estimated as 37 participants.
Interventions
DIAGNOSTIC_TESTspirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire
Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT), Short form-36 (SF-36) questionnaire and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.
Sponsors
Koc University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with Covid 19 diagnosis * Ability to read and speak * Signed informed consent. * Able to perform exercise testing and walking
Exclusion criteria
\- Subjects with limited exercise capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced vital capacity %predicted (FVC%) | at 6-12 months after discharge | in % |
| Short-form 36 questionnaire (SF-36) | at 6-12 months after discharge | scores range between 0 and 100 with higher scores indicating a better HRQoL |
| Oxygen uptake at peak exercise | at 6-12 months after discharge | from incremental Cardiopulmonary exercise test (% of predicted) |
| Minute-ventilation/carbon dioxide output during exercise | at 6-12 months after discharge | from incremental Cardiopulmonary exercise test (L/L) |
| Dyspnea during exercise | at 6-12 months after discharge | from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale |
| Thoracic CT findings | in the first week of pneumonia and at 6-12 months after discharge | lung parenchymal abnormalities as percentage of occupied lung |
| Forced expiratory volume in 1 second | at 6-12 months after discharge | in ml and %predicted |
| FEV1/FVC ratio | at 6-12 months after discharge | in % |
| Forced vital capacity (FVC) | at 6-12 months after discharge | in ml |
| Lung diffusion capacity for carbon monoxide (DLCO) | at 6-12 months after discharge | DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted) |
| 6-minute walk test distance | at 6-12 months after discharge | m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to hospital discharge | in hospital | in days |
| ICU discharge | in hospital | in days |
| Weaning from intubation | in the period of intensive care | in days |
| Weaning from supplemental oxygen | in hospital | in days |
| Weaning from noninvasive mechanical ventilation | in hospital | in days |
| Mortality | in hospital and at 6-12 months after discharge | recorded as present or absent |
| Signs and symptoms | in the first week of pneumonia and at 6-12 months after discharge | Recorded separately as present or absent) mortality (recorded as present or absent) |
Countries
Turkey (Türkiye)
Outcome results
None listed