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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599998
• Other study ID #: 2020.188.IRB1.056
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: May 2024
• Source: Koc University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 1, 2023
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pneumonia

Intervention

Diagnostic Test:
• spirometry, 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.

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koc University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced vital capacity (FVC)	in ml	at 6-12 months after discharge
Primary	Lung diffusion capacity for carbon monoxide (DLCO)	DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)	at 6-12 months after discharge
Primary	6-minute walk test distance	m	at 6-12 months after discharge
Primary	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
Primary	Oxygen uptake at peak exercise	from incremental Cardiopulmonary exercise test (% of predicted)	at 6-12 months after discharge
Primary	Minute-ventilation/carbon dioxide output during exercise	from incremental Cardiopulmonary exercise test (L/L)	at 6-12 months after discharge
Primary	Dyspnea during exercise	from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale	at 6-12 months after discharge
Primary	Thoracic CT findings	lung parenchymal abnormalities as percentage of occupied lung	in the first week of pneumonia and at 6-12 months after discharge
Primary	Forced expiratory volume in 1 second	in ml and %predicted	at 6-12 months after discharge
Primary	FEV1/FVC ratio	in %	at 6-12 months after discharge
Primary	Forced vital capacity %predicted (FVC%)	in %	at 6-12 months after discharge
Secondary	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
Secondary	Time to hospital discharge	in days	in hospital
Secondary	ICU discharge	in days	in hospital
Secondary	Weaning from intubation	in days	in the period of intensive care
Secondary	Weaning from supplemental oxygen	in days	in hospital
Secondary	Weaning from noninvasive mechanical ventilation	in days	in hospital
Secondary	Mortality	recorded as present or absent	in hospital and at 6-12 months after discharge