Colchicine and Post-COVID-19 Pulmonary Fibrosis

• Status: Completed
• Trial end date: 2021-10-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ClinAmygate
• Treatments: Colchicine

Criteria

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