drugset / Trial / NCT04756128

Impact of Colchicine and Low-dose Naltrexone on COVID-19

NCT04756128

RandomizedFactorialOpen-labelTreatment

Summary

The purpose of this study is to explore the impact of two medications-colchicine and low-dose naltrexone (LDN)-relative to standard of care (SOC) on COVID-19 disease progression to severe/critical illness and/or intubation in patients hospitalized with moderate COVID-19. As researchers have learned, COVID-19's clinical course suggests that the hyperinflammatory response seen in severe/critical cases is involved in the pathogenesis of associated adverse sequelae such as acute respiratory distress syndrome (ARDS), thromboembolic disease, and acute cardiac injury. Given colchicine has demonstrated clinical utility in inflammatory syndromes within these systems (e.g. endothelial/vascular/myocardial), and LDN acts both to boost the immune system, and limit an excessive response; they may prove useful in minimizing the risk of disease progression and associated adverse sequelae.

Timeline

Start
2021-01-25
Primary completion
2021-11-26
Completion
2021-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.6 mg Oral
Subject Naltrexone Small molecule 4.5 mg Oral

Indications