Status:
UNKNOWN
Colchicine and Post-COVID-19 Pulmonary Fibrosis
Lead Sponsor:
ClinAmygate
Conditions:
Covid19
Pulmonary Fibrosis Interstitial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, radiographi...
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 p...
Eligibility Criteria
Inclusion
- Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
- Age above 18 years old
- Informed written consent
Exclusion
- 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
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04818489
Start Date
March 25 2021
End Date
October 20 2023
Last Update
September 6 2023
Active Locations (1)
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1
El-Demerdash Hospital
Cairo, Egypt