Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia Related to Lung Functions, Radiology and Exercise Capacity

Conditions
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Covid19

Intervention / Treatment
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* Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 inpatients<br>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 | Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | in hospital 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signs and symptoms | Recorded separately as present or absent) mortality (recorded as present or absent) | in hospital and at 6-12 months after discharge | 
| Time to hospital discharge | in days | in hospital | 
| ICU discharge | in days | in hospital | 
| Weaning from intubation | in days | in hospital | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, lung functions, cardiopulmonary exercise testing, thoracic CT, 6 minute walking test, Short form 36 questionnaire