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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire

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.

• Study Type: Observational
• Enrollment (Anticipated): 37

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Koc University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with Covid-19 diagnosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Koc University Hospital
• Investigators: Study Chair: Benan Çağlayan, Prof Dr, Koç University Hospital Pulmonology Department

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Covid19; cardiopulmonary exercise testing; lung functions; thoracic CT; 6 minute walking test; Short form 36 questionnaire
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 2020.188.IRB1.056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No