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Completed

NCT Number: NCT04599998

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Forced vital capacity (FVC)

    Time frame: at 6-12 months after discharge

    in ml

  2. Lung diffusion capacity for carbon monoxide (DLCO)

    Time frame: at 6-12 months after discharge

    DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)

  3. 6-minute walk test distance

    Time frame: at 6-12 months after discharge

    m

  4. Short-form 36 questionnaire (SF-36)

    Time frame: at 6-12 months after discharge

    scores range between 0 and 100 with higher scores indicating a better HRQoL

  5. Oxygen uptake at peak exercise

    Time frame: at 6-12 months after discharge

    from incremental Cardiopulmonary exercise test (% of predicted)

  6. Minute-ventilation/carbon dioxide output during exercise

    Time frame: at 6-12 months after discharge

    from incremental Cardiopulmonary exercise test (L/L)

  7. Dyspnea during exercise

    Time frame: at 6-12 months after discharge

    from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale

  8. Thoracic CT findings

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

    lung parenchymal abnormalities as percentage of occupied lung

  9. Forced expiratory volume in 1 second

    Time frame: at 6-12 months after discharge

    in ml and %predicted

  10. FEV1/FVC ratio

    Time frame: at 6-12 months after discharge

    in %

  11. Forced vital capacity %predicted (FVC%)

    Time frame: at 6-12 months after discharge

    in %

Secondary outcomes

  1. Signs and symptoms

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

    Recorded separately as present or absent) mortality (recorded as present or absent)

  2. Time to hospital discharge

    Time frame: in hospital

    in days

  3. ICU discharge

    Time frame: in hospital

    in days

  4. Weaning from intubation

    Time frame: in the period of intensive care

    in days

  5. Weaning from supplemental oxygen

    Time frame: in hospital

    in days

  6. Weaning from noninvasive mechanical ventilation

    Time frame: in hospital

    in days

  7. Mortality

    Time frame: in hospital and at 6-12 months after discharge

    recorded as present or absent

Sponsors and collaborators

Lead sponsor

Koc University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 23, 2020
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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