COVID-19 Pneumonia Clinical Trial
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
Verified date | September 2023 |
Source | Centro Hospitalar Universitario do Algarve |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - previous lung cancer - previous intersticial lung disease |
Country | Name | City | State |
---|---|---|---|
Portugal | Hospital de Faro (CHUA) | Faro | |
Portugal | Hospital de Portimâo (CHUA) | Portimão |
Lead Sponsor | Collaborator |
---|---|
Centro Hospitalar Universitario do Algarve | Universidade do Algarve |
Portugal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of structural lung sequelae after COVID-19 pneumonia | evaluate the presence of lung structural sequelae with chest CT | 12 -14 months | |
Primary | Prevalence of functional lung impairment after COVID-19 pneumonia | evaluate the presence of impaired PFT after COVID-19 pneumonia | 12 -14 months | |
Primary | 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 | 12-14 months | |
Secondary | Prevalence of structural lung sequelae after COVID-19 pneumonia | evaluate the presence of lung structural sequelae with chest CT | 4-6 months | |
Secondary | Prevalence of functional lung impairment after COVID-19 pneumonia | evaluate the presence of impaired PFT after COVID-19 pneumonia | 4-6 months | |
Secondary | 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 | 4-6 months | |
Secondary | 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) | 4-6 months | |
Secondary | 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) | 12-14 months | |
Secondary | 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) | 4-6 months | |
Secondary | 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) | 12 -14 months |
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