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

PR00202

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.

2021-03-25

2021-08-25

2023-10-20

Active (not recruiting)

Early phase I

260

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The radiologist who will assess the CT scans will be blinded', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 260, 'type': 'ACTUAL'}}

2023-09-06