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

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

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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome; Lung Fibrosis
• Intervention / Treatment: Drug: Corticosteroids alone; Drug: Corticosteroids + Colchicine; Drug: Corticosteroids + Pirfenidone; Drug: Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days

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

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Patients received Corticosteroids only	Drug: Corticosteroids alone; (≥ 20 mg prednisolone or its equivalent for ≥ 10 days after hospital discharge); Other Names: Solupred; Disperlone; Methabiogen; Epicopred
Group B; Patients received Corticosteroids in combination with Colchicine	Drug: Corticosteroids + Colchicine; (≥ 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	Drug: Corticosteroids + Pirfenidone; (≥ 20 mg prednisolone or its equivalent for ≥ 10 days) + Pirfenidone (267 mg TID for ≥ 14 days); Other Names: Corticosteroids + Pirfinix
Group D; Patients received Corticosteroids in combination with Colchicine and Pirfenidone	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): September 15, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Fibrosis; COVID-19; Pulmonary Fibrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Pirfenidone; Colchicine
• Other Study ID Numbers: MD.21.09.526 - 2021/09/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymous'd individual data will be available with the corresponding author on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No