Colchicine and Post-COVID-19 Pulmonary Fibrosis

September 4, 2023 updated by: Emad R Issak, ClinAmygate

Impact of Colchicine on the Clinical Outcome of COVID-19 and the Development of Post-COVID-19 Pulmonary Fibrosis: Randomized Controlled Clinical Trial

Pulmonary fibrosis is a sequela to adult respiratory distress syndrome (ARDS). 40% of patients with corona virus disease 2019 (COVID-19) develop ARDS, and 20% of them are severe. Clinical, radiographic, and autopsy reports of pulmonary fibrosis were commonplace following SARS and MERS, and current evidence suggests pulmonary fibrosis could complicate infection by SARS-CoV-2 too. Colchicine has a direct anti-inflammatory effect by inhibiting the synthesis of tumor necrosis factor alpha and IL-6, monocyte migration, and the secretion of matrix metalloproteinase-9. It suppress secretion of cytokines and chemokines as well as in vitro platelet aggregation. All these are potentially beneficial effects that might diminish the COVID-19 inflammatory storm associated with severe cases.

Study Overview

Status

Active, not recruiting

Detailed Description

Approximately 96 million people have been diagnosed with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and around two million people have died from this deadly disease worldwide. The pulmonary symptoms associated with SARS-CoV-2 vary from mild respiratory symptoms to severe respiratory failure. Of those infected with SARS-CoV-2, 40% will progress to ARDS.

Radiologically, most of those infected by SARS COV 2 have bilateral lower lobes ground-glass opacities with or without consolidation. However, long term lung impairment may develop particularly interstitial lung disease (ILD), the fibrotic type. Besides, pulmonary fibrosis (PF) is recognized sequelae of ARDS, and several studies have shown that protective lung ventilation tends to diminish the radiographic abnormalities following ARDS.

Colchicine has anti-fibrotic effects as a microtubule-destabilizing agent. In an in vitro study using human lung fibroblasts, colchicine inhibited myofibroblast differentiation via Rho/serum response factor (SRF) dependent. In COVID19 cases, colchicine was used by where they assessed its impact on the inflammatory biomarkers and clinical outcomes.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • El-Demerdash hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
  • Age above 18 years old
  • Informed written consent

Exclusion Criteria:

  • History of hypersensitivity to colchicine
  • Pregnancy or breastfeeding women.
  • Patients with severe renal impairment (creatinine clearance (CCL) <30 mL / min)
  • Patients with severe hepatic impairment (AST or ALT> 5 times the normal limits in International Units (ULN)
  • Patients with blood dyscrasias, neutrophils <1.000 / mmc or platelets <50.000 / mmc
  • Patients with history of severe cardiac insufficiency
  • Patients with history of pulmonary fibrosis
  • Severe diarrhoea or bowel diverticulitis, or perforation
  • Patients who cannot take oral therapy
  • Patients already in ICU or requiring mechanical ventilation
  • Patients already enrolled in other clinical trials
  • Patients with taking P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a CYP3A4 inhibitor (e.g. ritonavir, remdesivir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) or Tocilizumab

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine group
Colchicine 0.5 mg (2 tablets: 1 mg) twice per day as a loading dose, followed by one tablet 0.5 twice per day for three weeks in addition to the local standard protocol of COVID19 management
colchicine 0.5 mg (2 tablets: 1 mg) twice per day as a loading dose, followed by one tablet 0.5 twice per day for three weeks in addition to the standard protocol
Other Names:
  • Colchicine
the local standard protocol for COVID19
Other Names:
  • the local standard protocol for COVID19
Placebo Comparator: Control group
the local standard protocol of COVID19 management
the local standard protocol for COVID19
Other Names:
  • the local standard protocol for COVID19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical status
Time Frame: Two weeks
Seven-category ordinal scale: minimum 1 is the best and a maximum is 6
Two weeks
Pulmonary fibrosis at week 2
Time Frame: Two weeks
Percent of Participants with pulmonary fibrosis
Two weeks
Pulmonary fibrosis at 45 days
Time Frame: 45 days
Percent of Participants with pulmonary fibrosis
45 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: Two weeks
Change in the levels of C-reactive protein
Two weeks
Ferritin
Time Frame: Two weeks
Change in the levels of Ferritin
Two weeks
Erythrocyte sedimentation rate
Time Frame: Two weeks
Change in the levels of Erythrocyte sedimentation rate
Two weeks
Lactate dehydrogenase
Time Frame: Two weeks
Change in the levels of Lactate dehydrogenase
Two weeks
Adverse events
Time Frame: 45 days
Adverse events related to the study medication
45 days
Pulmonary function test: FVC
Time Frame: 45 days
Pulmonary function test: FVC
45 days
Pulmonary function test: FEV1
Time Frame: 45 days
Pulmonary function test: FEV1
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Emad Issak, Ain Shams Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

August 25, 2021

Study Completion (Estimated)

October 20, 2023

Study Registration Dates

First Submitted

February 13, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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