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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 inpatients | Patients with laboratory and/or thoracic CT confirmed COVID-19 pneumonia ; older than18 years of age; treated as inpatients; evaluated at 6-12 months after hospital discharge in outpatient clinic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity (FVC) | in ml | at 6-12 months after discharge |
| Lung diffusion capacity for carbon monoxide (DLCO) | DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted) | at 6-12 months after discharge |
| 6-minute walk test distance | m | at 6-12 months after discharge |
| Short-form 36 questionnaire (SF-36) | scores range between 0 and 100 with higher scores indicating a better HRQoL | at 6-12 months after discharge |
| Oxygen uptake at peak exercise | from incremental Cardiopulmonary exercise test (% of predicted) | at 6-12 months after discharge |
| Minute-ventilation/carbon dioxide output during exercise | from incremental Cardiopulmonary exercise test (L/L) | at 6-12 months after discharge |
| Dyspnea during exercise | from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale | at 6-12 months after discharge |
| Thoracic CT findings | lung parenchymal abnormalities as percentage of occupied lung |
| Measure | Description | Time Frame |
|---|---|---|
| Signs and symptoms | Recorded separately as present or absent) mortality (recorded as present or absent) | in the first week of pneumonia and at 6-12 months after discharge |
| Time to hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects with limited exercise capacity
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Adults with Covid-19 diagnosis
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| Name | Affiliation | Role |
|---|---|---|
| Benan Çağlayan, Prof Dr | Koç University Hospital Pulmonology Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University Hospital | Istanbul | 34010 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013147 | Spirometry |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| in the first week of pneumonia and at 6-12 months after discharge |
| Forced expiratory volume in 1 second | in ml and %predicted | at 6-12 months after discharge |
| FEV1/FVC ratio | in % | at 6-12 months after discharge |
| Forced vital capacity %predicted (FVC%) | in % | at 6-12 months after discharge |
in days
| in hospital |
| ICU discharge | in days | in hospital |
| Weaning from intubation | in days | in the period of intensive care |
| Weaning from supplemental oxygen | in days | in hospital |
| Weaning from noninvasive mechanical ventilation | in days | in hospital |
| Mortality | recorded as present or absent | in hospital and at 6-12 months after discharge |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |