Anti-Inflammatory and Anti-Fibrotic Drugs in Post COVID-19 Pulmonary Fibrosis

Post-COVID-19 Syndrome Clinical Trial

Official title:

Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05648734
• Other study ID #: MD.21.09.526 - 2021/09/12
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: September 15, 2022

Study information

• Verified date: December 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

• Corticosteroids alone (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge) - Group A.

• Corticosteroids in combination with Colchicine (1 mg/day for ≥ 10 days) - Group B.

• Corticosteroids in combination with Pirfenidone (267 mg TID for ≥ 14 days) - Group C.

• Corticosteroids in combination with Colchicine and Pirfenidone (for ≥ 14 days) - Group D.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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: Corticosteroids alone.

• Corticosteroids in combination with Colchicine.

• Corticosteroids in combination with Pirfenidone.

• Corticosteroids in combination with Colchicine and Pirfenidone.

Exclusion Criteria:

• None COVID-19 pneumonia.

• Patients with previous parenchymal lung disease.

• Patients receiving anti-fibrotic or anti-inflammatory drugs due to other chronic disease.

• Patients who received anti-fibrotic and or ant inflammatory drugs for duration and or doses less than presumed or those who reported noncompliance to treatment.

• Patients with uncontrolled comorbidities.

• Patients who develop severe intolerable side effects or derangement of liver enzymes more than 5 folds.

• Pregnant ladies with COVID-19 pneumonia.

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Lung Fibrosis
• Post-COVID-19 Syndrome
• Pulmonary Fibrosis

Intervention

Drug:
• Corticosteroids alone
(= 20 mg prednisolone or its equivalent for = 10 days after hospital discharge)
• Corticosteroids + Colchicine
(= 20 mg prednisolone or its equivalent for = 10 days) + Colchicine (1 mg/day for = 10 days)
• Corticosteroids + Pirfenidone
(= 20 mg prednisolone or its equivalent for = 10 days) + Pirfenidone (267 mg TID for = 14 days)
• Corticosteroids + Colchicine + Pirfenidone for = 14 days
(= 20 mg prednisolone or its equivalent for = 10 days) + Colchicine (1 mg/day for = 10 days) + Pirfenidone (267 mg TID for = 14 days)

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Functions Test	Change in FVC from 1 month to 3 months follow up after hospital discharge	8 weeks
Primary	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