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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Patients received Corticosteroids only |
| |
| Group B | Patients received Corticosteroids in combination with Colchicine |
| |
| Group C | Patients received Corticosteroids in combination with Pirfenidone |
| |
| Group D | Patients received Corticosteroids in combination with Colchicine and Pirfenidone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroids alone | Drug | (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Functions Test | Change in FVC from 1 month to 3 months follow up after hospital discharge | 8 weeks |
| Radiological scoring | 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 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Amina Abdel Maksoud, MD | Mansoura University, Faculty of Medicine | Study Director |
| Dalia Fahmy, MD | Mansoura University, Faculty of Medicine | Study Director |
| Aida Yousef, MD | Mansoura University, Faculty of Medicine | Study Director |
| Mohamed Tohlob, MD | Mansoura University, Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
Anonymous'd individual data will be available with the corresponding author on reasonable request
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D003078 | Colchicine |
| C093844 | pirfenidone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Corticosteroids + Colchicine | Drug | (≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) |
|
| Corticosteroids + Pirfenidone | Drug | (≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days) |
|
|
| Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days | Drug | (≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days) |
|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |