Covid19 Clinical Trial - Colchicine & Post-COVID-19 Pulmonary Fibrosis

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04818489
Study type	Interventional
Source	ClinAmygate
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	March 25, 2021
Completion date	October 20, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05047692` - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers	Phase 1
Recruiting	`NCT04395768` - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19	Phase 2
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04508777` - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed	`NCT04506268` - COVID-19 SAFE Enrollment	N/A
Completed	`NCT04961541` - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine	Phase 1/Phase 2
Active, not recruiting	`NCT04546737` - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients	N/A
Terminated	`NCT04581915` - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19	Phase 2/Phase 3
Not yet recruiting	`NCT04543006` - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19	N/A
Completed	`NCT04494646` - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)	Phase 2
Completed	`NCT04532294` - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants	Phase 1
Terminated	`NCT04542993` - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy	Phase 2
Completed	`NCT04537663` - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults	Phase 4
Not yet recruiting	`NCT04527211` - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel	Phase 3
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04387292` - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic	N/A
Completed	`NCT04979858` - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask	N/A
Not yet recruiting	`NCT05038449` - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19	N/A
Completed	`NCT04610502` - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients	Phase 2
Active, not recruiting	`NCT06042855` - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Colchicine and Post-COVID-19 Pulmonary Fibrosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms