COVID-19 PneumoniaNCT05835128
Assessment of Long-term Sequelae of Coronavirus Disease 2019 (COVID-19) Pneumonia With Chest CT and Pulmonary Function Tests
An observational study of COVID-19 Pneumonia and Sequelae of; Infection, run by Centro Hospitalar Universitario do Algarve at 2 sites in Portugal.
Trial summary
The goal of this prospective multicentric study is to evaluate the presence of long-term pulmonary sequelae in patients who had required hospitalization for treating COVID-19 pneumonia, trough chest CT and pulmonary function tests (PFT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia, Sequelae of; Infection, Respiratory Function Impaired
- How many people
- 250 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Mar 2020to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted in two Portuguese hospitals from the same institution (university center). Patients will be recruited from the follow -up Post-COVID-19 medical consultations. All patients attending these follow- up consultations will be invited to participate and enrolled if they agree to sign the written informed consent (following the ethics committee protocol).
Who may be able to join
- at least 18 years old of age;
- positive SARS-CoV-2 reverse transcription-polymerase chain reaction on a nasopharyngeal and/or oropharyngeal swab or positive SARS-CoV-2 rapid antigen test
- hospitalization in one of two hospitals of our institution (university center) in consequence of SARS-CoV-2 related disease between march of 2020 and march of 2022 and having :
- respiratory insufficiency when admitted or developing after admission or image documented viral pneumonia ;
- at least one thorax x-ray or lung CT acquired during the hospitalization period
Who cannot join
- previous lung cancer
- previous intersticial lung disease
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Hospital de Faro (CHUA)
Faro, 8005
Hospital de Portimâo (CHUA)
Portimão, 8500-338
About this study
Official title: A Multicentric Prospective Study: Assessment of Pulmonary Long-term Sequelae of Coronavirus Disease 2019 (COVID-19) Pneumonia With Chest Computed Tomography and Pulmonary Function Tests
The goal of this prospective multicentric study is to evaluate the presence of long-term pulmonary sequelae in patients who had required hospitalization for treating COVID-19 pneumonia, trough chest CT and pulmonary function tests (PFT).
Secondly we would like to evaluate the possible correlation between the chest CT findings and pulmonary function tests pre-existing co-morbidities and type of therapy used during hospitalization.
Read the detailed description
The investigators will invite to participate in this study patients who had been hospitalized with positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) , namely with positive reverse transcription polymerase chain reaction or positive rapid antigen test, and with respiratory insufficiency (at admission or developed during hospital stay), or with viral pneumonia documented with thorax x-ray or Chest CT, during the period between march 2020 and march 2022.
Patients who agree to participate and sign the informed consent will be enrolled in the study.
Participants will be evaluate in two different periods: approximately 4 to 6 months after hospital discharge and approximately 12 to 14 months after hospital discharge.
The first evaluation includes a physical examination at medical post-COVID-19 consultation, pulmonary function tests and reduced dose chest CT.
The second evaluation includes a physical examination at medical post-COVID-19 consultation, and will include reduced dose chest CT and pulmonary function tests only if there were significative findings on those exams on the first evaluation, or if there are any clinical significative findings at the present moment.
All the evaluations must respect the following time intervals: the pulmonary function tests and the chest CT will be done within a 6 week maximum interval of each other, and both of these examinations will be done within a 8 week maximum interval regarding the clinical evaluation.
Demographic and clinical data will be collected by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation) and the patient will given the EuroQol 5 Dimension 5 Level questionnaire (EQ-5D-3L) to assess the health status.
The reduced dose Chest CT will be obtained with the patient in a supine position and with breath-holding following inspiration, in a spiral acquisition mode with a 1 ,5 mm slice thickness and the images will be reviewed by four senior radiologist blinded to clinical and respiratory functional tests results.
The pulmonary function tests will be interpreted according to the American Thoracic Society and European Respiratory Society guidelines 2022. The parameters measured included the forced expiratory flow between 25% and 75% of forced vital capacity (FVC), forced expiratory volume (FEV1), FVC/FEV1, vital capacity, total lung capacity, residual volume and the diffusing capacity of lung for carbone monoxide (DLCO), DLCO/Alveolar Volume (AV).
- Conditions
- COVID-19 Pneumonia, Sequelae of; Infection, Respiratory Function Impaired, SARS CoV 2 Infection, SARS-CoV 2 Pneumonia
- Keywords
- COVID-19, Tomography, Infections, Viral, Respiratory Tract Infections, Virus Disease, Coronavirus Infections, Infections, Lung Diseases, RNA virus infections, Respiratory tract diseases, Chest CT, Reduced dose chest CT, Lung CT, coronaviridae infections, lung sequela, pneumonia, respiratory function tests, follow-up studies, multicentric studies, prospective studies
- Medical subject headings
- Infections, Respiratory Insufficiency, COVID-19, Virus Diseases, Respiratory Tract Infections, Coronavirus Infections, Lung Diseases, RNA Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of structural lung sequelae after COVID-19 pneumonia
evaluate the presence of lung structural sequelae with chest CT
Measured: 12 -14 months
Prevalence of functional lung impairment after COVID-19 pneumonia
evaluate the presence of impaired PFT after COVID-19 pneumonia
Measured: 12 -14 months
Association between chest CT findings and PFT impairment after COVID-19 pneumonia
evaluate the possible correlation between the presence of pulmonary structural alterations on chest CT and the presence of impaired PFT
Measured: 12-14 months
Secondary outcomes (7)
Prevalence of structural lung sequelae after COVID-19 pneumonia
evaluate the presence of lung structural sequelae with chest CT
Measured: 4-6 months
Prevalence of functional lung impairment after COVID-19 pneumonia
evaluate the presence of impaired PFT after COVID-19 pneumonia
Measured: 4-6 months
Association between chest CT findings and PFT impairment after COVID-19 pneumonia
evaluate the possible correlation between the presence of pulmonary structural alterations on chest CT and the presence of impaired PFT
Measured: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization
to evaluate if there is any association between the presence of lung structural sequelae on chest CT and the different treatments used during hospitalization (corticotherapy, oxygen therapy, mechanical ventilation)
Measured: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization
to evaluate if there is any association between the presence of lung structural sequelae on chest CT and the different treatments used during hospitalization (corticotherapy, oxygen therapy, mechanical ventilation)
Measured: 12-14 months
Association between chest CT findings after COVID-19 pneumonia and pre-existing co-morbidities
to evaluate if there is any association between the presence of lung structural sequelae on chest CT and pre-existing co-morbidities (diabetes, asthma, hypertension, dyslipidaemia, obesity, chronic obstructive pulmonary disease, cigarette smoking, heart disease and kidney disease)
Measured: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and pre-existing co-morbidities
to evaluate if there is any association between the presence of lung structural sequelae on chest CT and pre-existing co-morbidities (diabetes, asthma, hypertension, dyslipidaemia, obesity,, chronic obstructive pulmonary disease, cigarette smoking, heart disease and kidney disease)
Measured: 12 -14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitario do Algarve
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Algarve
- Responsible party
- Principal investigator, Mónica Diniz, MD, Centro Hospitalar Universitario do Algarve
- Investigators
- Mónica Diniz, MD, Principal investigator, unafilliatedCastro Miguel, MD, Principal investigator, Centro Hospitalar Universitário do Algarve/Polo de Portimão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835128
- Sponsor's protocol ID
- UAIF 96/2020
- Status last verified
- Sep 2023
- First submitted
- 25 Apr 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Prospective Study: Assessment of Pulmonary Long-term Sequelae of Coronavirus Disease 2019 (COVID-19) Pneumonia With Chest Computed Tomography and Pulmonary Function Tests
- ClinicalTrials.gov ID
- NCT05835128
- Acronym / sponsor ID
- UAIF 96/2020
- Conditions
- COVID-19 Pneumonia, Sequelae of; Infection, Respiratory Function Impaired, SARS CoV 2 Infection, SARS-CoV 2 Pneumonia
- Keywords
- COVID-19, Tomography, Infections, Viral, Respiratory Tract Infections, Virus Disease, Coronavirus Infections, Infections, Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitario do AlgarveUniversity, hospital or other
- Collaborators
- Universidade do Algarve
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Apr 2023 (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.
The goal of this prospective multicentric study is to evaluate the presence of long-term pulmonary sequelae in patients who had required hospitalization for treating COVID-19 pneumonia, trough chest CT and pulmonary function tests (PFT).
Secondly we would like to evaluate the possible correlation between the chest CT findings and pulmonary function tests pre-existing co-morbidities and type of therapy used during hospitalization.
Detailed description
The investigators will invite to participate in this study patients who had been hospitalized with positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) , namely with positive reverse transcription polymerase chain reaction or positive rapid antigen test, and with respiratory insufficiency (at admission or developed during hospital stay), or with viral pneumonia documented with thorax x-ray or Chest CT, during the period between march 2020 and march 2022.
Patients who agree to participate and sign the informed consent will be enrolled in the study.
Participants will be evaluate in two different periods: approximately 4 to 6 months after hospital discharge and approximately 12 to 14 months after hospital discharge.
The first evaluation includes a physical examination at medical post-COVID-19 consultation, pulmonary function tests and reduced dose chest CT.
The second evaluation includes a physical examination at medical post-COVID-19 consultation, and will include reduced dose chest CT and pulmonary function tests only if there were significative findings on those exams on the first evaluation, or if there are any clinical significative findings at the present moment.
All the evaluations must respect the following time intervals: the pulmonary function tests and the chest CT will be done within a 6 week maximum interval of each other, and both of these examinations will be done within a 8 week maximum interval regarding the clinical evaluation.
Demographic and clinical data will be collected by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation) and the patient will given the EuroQol 5 Dimension 5 Level questionnaire (EQ-5D-3L) to assess the health status.
The reduced dose Chest CT will be obtained with the patient in a supine position and with breath-holding following inspiration, in a spiral acquisition mode with a 1 ,5 mm slice thickness and the images will be reviewed by four senior radiologist blinded to clinical and respiratory functional tests results.
The pulmonary function tests will be interpreted according to the American Thoracic Society and European Respiratory Society guidelines 2022. The parameters measured included the forced expiratory flow between 25% and 75% of forced vital capacity (FVC), forced expiratory volume (FEV1), FVC/FEV1, vital capacity, total lung capacity, residual volume and the diffusing capacity of lung for carbone monoxide (DLCO), DLCO/Alveolar Volume (AV).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in two Portuguese hospitals from the same institution (university center). Patients will be recruited from the follow -up Post-COVID-19 medical consultations. All patients attending these follow- up consultations will be invited to participate and enrolled if they agree to sign the written informed consent (following the ethics committee protocol).
Key inclusion criteria (5 listed)
- at least 18 years old of age;
- positive SARS-CoV-2 reverse transcription-polymerase chain reaction on a nasopharyngeal and/or oropharyngeal swab or positive SARS-CoV-2 rapid antigen test
- hospitalization in one of two hospitals of our institution (university center) in consequence of SARS-CoV-2 related disease between march of 2020 and march of 2022 and having :
- respiratory insufficiency when admitted or developing after admission or image documented viral pneumonia ;
- at least one thorax x-ray or lung CT acquired during the hospitalization period
Key exclusion criteria (2 listed)
- previous lung cancer
- previous intersticial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of structural lung sequelae after COVID-19 pneumonia
Time frame: 12 -14 months
evaluate the presence of lung structural sequelae with chest CT
Prevalence of functional lung impairment after COVID-19 pneumonia
Time frame: 12 -14 months
evaluate the presence of impaired PFT after COVID-19 pneumonia
Association between chest CT findings and PFT impairment after COVID-19 pneumonia
Time frame: 12-14 months
evaluate the possible correlation between the presence of pulmonary structural alterations on chest CT and the presence of impaired PFT
7 secondary outcomes
Prevalence of structural lung sequelae after COVID-19 pneumonia
Time frame: 4-6 months
Prevalence of functional lung impairment after COVID-19 pneumonia
Time frame: 4-6 months
Association between chest CT findings and PFT impairment after COVID-19 pneumonia
Time frame: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization
Time frame: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and therapy used during hospitalization
Time frame: 12-14 months
Association between chest CT findings after COVID-19 pneumonia and pre-existing co-morbidities
Time frame: 4-6 months
Association between chest CT findings after COVID-19 pneumonia and pre-existing co-morbidities
Time frame: 12 -14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruitingPhase 2
Prevention of COVID-19 Infection to Severe Pneumonia or ARDS
Covid19 Pneumonia
RecruitingPhase 3
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
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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.
Mónica Diniz, MD principal investigator
unafilliated
Castro Miguel, MD principal investigator
Centro Hospitalar Universitário do Algarve/Polo de Portimão
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Sequelae of; Infection, run by Centro Hospitalar Universitario do Algarve at 2 sites in Portugal.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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?
Results are not available in the source record.
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?
Prevalence of structural lung sequelae after COVID-19 pneumonia (time frame: 12 -14 months). The study lists 3 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 29 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.