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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05648734
Collaborator
(none)
200
Enrollment
1
Location
6.2
Actual Duration (Months)
32.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

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 Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Impact of Anti-Inflammatory and Anti-Fibrotic Drugs on Post-acute COVID-19 Pulmonary Fibrosis
Actual Study Start Date :
Mar 10, 2022
Actual Primary Completion Date :
Jun 15, 2022
Actual Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm 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)

    Outcome Measures

    Primary Outcome Measures

    1. Pulmonary Functions Test [8 weeks]

      Change in FVC from 1 month to 3 months follow up after hospital discharge

    2. Radiological scoring [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura University Mansoura Dakahlia Egypt 35511

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mansoura University
    ClinicalTrials.gov Identifier:
    NCT05648734
    Other Study ID Numbers:
    • MD.21.09.526 - 2021/09/12
    First Posted:
    Dec 13, 2022
    Last Update Posted:
    Dec 13, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    COVID-19
    Pulmonary Fibrosis
    Fibrosis
    Pirfenidone
    Colchicine

    Study Results

    No Results Posted as of Dec 13, 2022