Clinical trial NCT04599998: Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia
Official title: Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia Related to Lung Functions, Radiology and Exercise Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Covid19
lung functions
cardiopulmonary exercise testing
thoracic CT
6 minute walking test
Short form 36 questionnaire
Lead sponsor: Koc University Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with Covid-19 diagnosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: at 6-12 months after discharge
measure: Lung diffusion capacity for carbon monoxide (DLCO)
timeFrame: at 6-12 months after discharge
measure: 6-minute walk test distance
timeFrame: at 6-12 months after discharge
measure: Short-form 36 questionnaire (SF-36)
timeFrame: at 6-12 months after discharge
measure: Oxygen uptake at peak exercise
timeFrame: at 6-12 months after discharge
measure: Minute-ventilation/carbon dioxide output during exercise
timeFrame: at 6-12 months after discharge
measure: Dyspnea during exercise
timeFrame: at 6-12 months after discharge
measure: Thoracic CT findings
timeFrame: in the first week of pneumonia and at 6-12 months after discharge
measure: Forced expiratory volume in 1 second
timeFrame: at 6-12 months after discharge
measure: FEV1/FVC ratio
timeFrame: at 6-12 months after discharge
measure: Forced vital capacity %predicted (FVC%)
timeFrame: at 6-12 months after discharge
Secondary outcomes:
measure: Signs and symptoms
timeFrame: in the first week of pneumonia and at 6-12 months after discharge
measure: Time to hospital discharge
timeFrame: in hospital
measure: ICU discharge
timeFrame: in hospital
measure: Weaning from intubation
timeFrame: in the period of intensive care
measure: Weaning from supplemental oxygen
timeFrame: in hospital
measure: Weaning from noninvasive mechanical ventilation
timeFrame: in hospital
measure: Mortality
timeFrame: in hospital and at 6-12 months after discharge
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
Study officials:
affiliation: Koç University Hospital Pulmonology Department
name: Benan Çağlayan, Prof Dr
role: STUDY_CHAIR
References: