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

NCT04599998 | Completed

• 1 other identifier: 2020.188.IRB1.056
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; lung functions; cardiopulmonary exercise testing; thoracic CT; 6 minute walking test; Short form 36 questionnaire

Outcome Measures

Primary Outcomes (11)

• 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 the first week of pneumonia 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 Outcomes (7)

• Signs and symptoms

  in the first week of pneumonia and at 6-12 months after discharge

• Time to hospital discharge

  in hospital

• ICU discharge

  in hospital

• Weaning from intubation

  in the period of intensive care

• Weaning from supplemental oxygen

  in hospital

Study Arms (1)

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

Interventions

spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire DIAGNOSTIC_TEST

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.

COVID-19 inpatients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with Covid-19 diagnosis

You may qualify if:

• Adult patients with Covid 19 diagnosis
• Ability to read and speak
• Signed informed consent.
• Able to perform exercise testing and walking

You may not qualify if:

• \- Subjects with limited exercise capacity

Sponsors & Collaborators

• Koc University Hospital: lead

Study Sites (1)

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Spirometry; Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Ergometry; Investigative Techniques

Study Officials

• Benan Çağlayan, Prof Dr

  Koç University Hospital Pulmonology Department

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 15, 2020
• Primary Completion: February 15, 2022
• Study Completion: March 1, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)