Mansoura University
Al Mansurah, Dakahlia Governorate, 35511, Egypt
NCT Number: NCT05648734
In this study we aim to evaluate the radiological and functional changes in post-acute covid-19 pulmonary fibrosis patients in relation to anti-inflammatory and/or antifibrotic drugs prescribed during and after covid-19 pneumonia.
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Notify Me18 year and older
All sexes
Observational
Al Mansurah, Dakahlia Governorate, 35511, Egypt
This study is a prospective and retrospective cohort study in which post COVID-19 patients who are following up at post COVID-19 clinic are evaluated regarding presence and degree of Post COVID-19 Pulmonary Fibrosis (PCPF) in relation to anti-inflammatory and/or anti-fibrotic drugs.
Adult patients who have COVID-19 pneumonia confirmed either by RT-PCR or radiologically by CT scan and according to WHO severity classification are (Moderate, severe, or critical) and has received either:
Pulmonary function test: Spirometry: measurement of lung volumes and capacities (forced expiratory volume in first second FEV1, Forced Vital Capacity FVC, FEV1/FVC and FEF25/75) after 1 month and 3 months of the onset of symptoms.
Radiological scoring: Baseline High resolution CT scan of the chest will be performed at baseline, 1 month and 3 months after onset of symptoms. Chest CT-Severity Scoring (Chest CT-SS) for assessing COVID-19 burden on the initial scan will be calculated. This score uses lung opacification as a surrogate for extension of the disease in the lungs. According to the anatomic structure, the 18 segments of both lungs were divided into 20 regions, in which the posterior apical segment of the left upper lobe was subdivided into apical and posterior segmental regions, whereas the anteromedial basal segment of the left lower lobe was subdivided into anterior and basal segmental regions. The lung opacities in all the 20 lung regions were subjectively evaluated on chest CT images using a system attributing score of 0, 1, and 2 if parenchymal opacification involved 0%, less than 50%, or equal to or more than 50% of each region, respectively. The CT-SS was defined as the sum of the individual scores in the 20 lung segment regions, which may range from 0 to 40 points
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge)
Other names: Solupred, Disperlone, Methabiogen, Epicopred
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days)
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)
Other names: Corticosteroids + Pirfinix
(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)
Time frame: 8 weeks
Change in FVC from 1 month to 3 months follow up after hospital discharge
Time frame: 8 weeks
Change in Chest CT Severity Scoring (Chest CT-SS) from 1 month to 3 months follow up after hospital discharge compared to baseline CT Chest scan
Mansoura University
Other
Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis
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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