Covid19NCT04599998
Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia
An observational study of Covid19, run by Koc University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Covid-19 diagnosis
Who may be able to join
- Adult patients with Covid 19 diagnosis
- Ability to read and speak
- Signed informed consent.
- Able to perform exercise testing and walking
Who cannot join
- Subjects with limited exercise capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire
- Keywords
- Covid19, lung functions, cardiopulmonary exercise testing, thoracic CT, 6 minute walking test, Short form 36 questionnaire
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaireDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity (FVC)
in ml
Measured: at 6-12 months after discharge
Lung diffusion capacity for carbon monoxide (DLCO)
DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)
Measured: at 6-12 months after discharge
6-minute walk test distance
m
Measured: 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
Measured: at 6-12 months after discharge
Oxygen uptake at peak exercise
from incremental Cardiopulmonary exercise test (% of predicted)
Measured: at 6-12 months after discharge
Minute-ventilation/carbon dioxide output during exercise
from incremental Cardiopulmonary exercise test (L/L)
Measured: at 6-12 months after discharge
Dyspnea during exercise
from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale
Measured: at 6-12 months after discharge
Thoracic CT findings
lung parenchymal abnormalities as percentage of occupied lung
Measured: in the first week of pneumonia and at 6-12 months after discharge
Forced expiratory volume in 1 second
in ml and %predicted
Measured: at 6-12 months after discharge
FEV1/FVC ratio
in %
Measured: at 6-12 months after discharge
Forced vital capacity %predicted (FVC%)
in %
Measured: at 6-12 months after discharge
Secondary outcomes (7)
Signs and symptoms
Recorded separately as present or absent) mortality (recorded as present or absent)
Measured: in the first week of pneumonia and at 6-12 months after discharge
Time to hospital discharge
in days
Measured: in hospital
ICU discharge
in days
Measured: in hospital
Weaning from intubation
in days
Measured: in the period of intensive care
Weaning from supplemental oxygen
in days
Measured: in hospital
Weaning from noninvasive mechanical ventilation
in days
Measured: in hospital
Mortality
recorded as present or absent
Measured: in hospital and at 6-12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Feb 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Işıl Uzel, Koc University Hospital
- Investigators
- Benan Çağlayan, Prof Dr, Study chair, Koç University Hospital Pulmonology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599998
- Sponsor's protocol ID
- 2020.188.IRB1.056
- Status last verified
- May 2024
- First submitted
- 19 Oct 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Findings of Inpatients for COVID-19 Pneumonia Related to Lung Functions, Radiology and Exercise Capacity
- ClinicalTrials.gov ID
- NCT04599998
- Acronym / sponsor ID
- 2020.188.IRB1.056
- Conditions
- Covid19
- Keywords
- Covid19, lung functions, cardiopulmonary exercise testing, thoracic CT, 6 minute walking test, Short form 36 questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 inpatients | – | Diagnostic Test: spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnairePatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Covid-19 diagnosis
Key inclusion criteria (4 listed)
- Adult patients with Covid 19 diagnosis
- Ability to read and speak
- Signed informed consent.
- Able to perform exercise testing and walking
Key exclusion criteria (1 listed)
- Subjects with limited exercise capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaireParticipants 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. | Diagnostic test | COVID-19 inpatients |
Primary outcome
Forced vital capacity (FVC)
Time frame: at 6-12 months after discharge
in ml
Lung diffusion capacity for carbon monoxide (DLCO)
Time frame: at 6-12 months after discharge
DLCO (%predicted); DLCO/alveolar volume- DLCO/VA (%predicted)
6-minute walk test distance
Time frame: at 6-12 months after discharge
m
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
Oxygen uptake at peak exercise
Time frame: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (% of predicted)
Minute-ventilation/carbon dioxide output during exercise
Time frame: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (L/L)
Dyspnea during exercise
Time frame: at 6-12 months after discharge
from incremental Cardiopulmonary exercise test (measured with 10-point categorical Borg scale
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
Forced expiratory volume in 1 second
Time frame: at 6-12 months after discharge
in ml and %predicted
FEV1/FVC ratio
Time frame: at 6-12 months after discharge
in %
Forced vital capacity %predicted (FVC%)
Time frame: at 6-12 months after discharge
in %
7 secondary outcomes
Signs and symptoms
Time frame: in the first week of pneumonia and at 6-12 months after discharge
Time to hospital discharge
Time frame: in hospital
ICU discharge
Time frame: in hospital
Weaning from intubation
Time frame: in the period of intensive care
Weaning from supplemental oxygen
Time frame: in hospital
Weaning from noninvasive mechanical ventilation
Time frame: in hospital
Mortality
Time frame: in hospital and at 6-12 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benan Çağlayan, Prof Dr study chair
Koç University Hospital Pulmonology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Koc University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (FVC) (time frame: at 6-12 months after discharge). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.