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

NCT05648734 | Completed FDA Drug

• 1 other identifier: MD.21.09.526 - 2021/09/12
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome; Lung Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Group A

Patients received Corticosteroids only

Drug: Corticosteroids alone

Group B

Patients received Corticosteroids in combination with Colchicine

Drug: Corticosteroids + Colchicine

Group C

Patients received Corticosteroids in combination with Pirfenidone

Drug: Corticosteroids + Pirfenidone

Group D

Patients received Corticosteroids in combination with Colchicine and Pirfenidone

Drug: Corticosteroids + Colchicine + Pirfenidone for ≥ 14 days

Interventions

Corticosteroids alone DRUG

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

Also known as: Solupred, Disperlone, Methabiogen, Epicopred

Group A

Corticosteroids + Colchicine DRUG

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

Group B

Corticosteroids + Pirfenidone DRUG

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

Also known as: Corticosteroids + Pirfinix

Group C

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)

Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Pulmonary Fibrosis

Interventions

Adrenal Cortex Hormones; Colchicine; pirfenidone

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Alkaloids; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 13, 2022
• Study Start: March 10, 2022
• Primary Completion: June 15, 2022
• Study Completion: September 15, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)