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

NCT ID: NCT05648734

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-09-15

Brief 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.

Detailed 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

Conditions

Post-COVID-19 Syndrome; Lung Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Group A

Patients received Corticosteroids only

Corticosteroids alone

Intervention Type: DRUG

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge)

Group B

Patients received Corticosteroids in combination with Colchicine

Corticosteroids + Colchicine

Intervention Type: DRUG

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days)

Group C

Patients received Corticosteroids in combination with Pirfenidone

Corticosteroids + Pirfenidone

Intervention Type: DRUG

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)

Group D

Patients received Corticosteroids in combination with Colchicine and Pirfenidone

Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days

Intervention Type: DRUG

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)

Interventions

Corticosteroids alone

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge)

Intervention Type: DRUG

Corticosteroids + Colchicine

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Colchicine (1 mg/day for ≥ 10 days)

Intervention Type: DRUG

Corticosteroids + Pirfenidone

(≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Other Intervention Names

Solupred; Disperlone; Methabiogen; Epicopred; Corticosteroids + Pirfinix

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amina Abdel Maksoud, MD

Role: STUDY_DIRECTOR

Mansoura University, Faculty of Medicine

Dalia Fahmy, MD

Role: STUDY_DIRECTOR

Mansoura University, Faculty of Medicine

Aida Yousef, MD

Role: STUDY_DIRECTOR

Mansoura University, Faculty of Medicine

Mohamed Tohlob, MD

Role: STUDY_DIRECTOR

Mansoura University, Faculty of Medicine

Locations

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MD.21.09.526 - 2021/09/12

Identifier Type: -

Identifier Source: org_study_id