Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia
- Conditions
- Covid19
- Interventions
- Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire
- Registration Number
- NCT04599998
- Lead Sponsor
- Koc University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Adult patients with Covid 19 diagnosis
- Ability to read and speak
- Signed informed consent.
- Able to perform exercise testing and walking
- Subjects with limited exercise capacity
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 inpatients spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire 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
- Primary Outcome Measures
Name Time Method Forced expiratory volume in 1 second at 6-12 months after discharge in ml and %predicted
Forced vital capacity %predicted (FVC%) at 6-12 months after discharge in %
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
Dyspnea during exercise at 6-12 months after discharge from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale
Oxygen uptake at peak exercise at 6-12 months after discharge from incremental Cardiopulmonary exercise test (% of predicted)
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 vital capacity (FVC) at 6-12 months after discharge in ml
Minute-ventilation/carbon dioxide output during exercise at 6-12 months after discharge from incremental Cardiopulmonary exercise test (L/L)
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
FEV1/FVC ratio at 6-12 months after discharge in %
- Secondary Outcome Measures
Name Time Method Weaning from intubation in the period of intensive care in days
Time to hospital discharge in hospital in days
Weaning from noninvasive mechanical ventilation in hospital in days
ICU discharge 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)
Weaning from supplemental oxygen in hospital in days
Trial Locations
- Locations (1)
Koç University Hospital
🇹🇷Istanbul, Turkey