- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04818489
Colchicine and Post-COVID-19 Pulmonary Fibrosis
Impact of Colchicine on the Clinical Outcome of COVID-19 and the Development of Post-COVID-19 Pulmonary Fibrosis: Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cairo, Egypt
- El-Demerdash hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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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:
the local standard protocol for COVID19
Other Names:
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Placebo Comparator: Control group
the local standard protocol of COVID19 management
|
the local standard protocol for COVID19
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical status
Time Frame: Two weeks
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Seven-category ordinal scale: minimum 1 is the best and a maximum is 6
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Two weeks
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Pulmonary fibrosis at week 2
Time Frame: Two weeks
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Percent of Participants with pulmonary fibrosis
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Two weeks
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Pulmonary fibrosis at 45 days
Time Frame: 45 days
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Percent of Participants with pulmonary fibrosis
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45 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C-reactive protein
Time Frame: Two weeks
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Change in the levels of C-reactive protein
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Two weeks
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Ferritin
Time Frame: Two weeks
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Change in the levels of Ferritin
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Two weeks
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Erythrocyte sedimentation rate
Time Frame: Two weeks
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Change in the levels of Erythrocyte sedimentation rate
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Two weeks
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Lactate dehydrogenase
Time Frame: Two weeks
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Change in the levels of Lactate dehydrogenase
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Two weeks
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Adverse events
Time Frame: 45 days
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Adverse events related to the study medication
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45 days
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Pulmonary function test: FVC
Time Frame: 45 days
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Pulmonary function test: FVC
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45 days
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Pulmonary function test: FEV1
Time Frame: 45 days
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Pulmonary function test: FEV1
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45 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emad Issak, Ain Shams Univeristy
Publications and helpful links
General Publications
- Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
- Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P, Metallidis S, Sianos G, Baltagiannis S, Panagopoulos P, Dolianitis K, Randou E, Syrigos K, Kotanidou A, Koulouris NG, Milionis H, Sipsas N, Gogos C, Tsoukalas G, Olympios CD, Tsagalou E, Migdalis I, Gerakari S, Angelidis C, Alexopoulos D, Davlouros P, Hahalis G, Kanonidis I, Katritsis D, Kolettis T, Manolis AS, Michalis L, Naka KK, Pyrgakis VN, Toutouzas KP, Triposkiadis F, Tsioufis K, Vavouranakis E, Martinez-Dolz L, Reimers B, Stefanini GG, Cleman M, Goudevenos J, Tsiodras S, Tousoulis D, Iliodromitis E, Mehran R, Dangas G, Stefanadis C; GRECCO-19 investigators. Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e2013136. doi: 10.1001/jamanetworkopen.2020.13136.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Lung Diseases, Interstitial
- Fibrosis
- COVID-19
- Pulmonary Fibrosis
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
Other Study ID Numbers
- PR00202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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