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

PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

November 26, 2021

Study Completion Date

December 12, 2021

Conditions
Covid19
Interventions
DRUG

Colchicine 0.6 mg

"Colchicine is an oral anti-inflammatory agent that is relatively inexpensive, readily available, and has been used for generations. Approved for treatment and prophylaxis of gout flares and Mediterranean fever, it is also used in a variety of other inflammatory conditions (e.g. pericarditis and diffuse vascular inflammation such as Behcet syndrome). Colchicine binds to tubulin causing depolymerization, which interferes with neutrophil chemotaxis, adhesion, and mobilization to sites of inflammation, and contributes to reduction in superoxide production; through interference of the NLRP3 inflammasome protein complex, colchicine inhibits IL-1b, IL-6, and IL-18 production.~For this study, patients enrolled in a colchicine containing arm will receive 0.6mg of colchicine BID (unless renal function/gastrointestinal issues require adjustments described in the protocol)"

DRUG

Naltrexone

"Most well known as an opioid antagonist, or a treatment for alcohol dependence, naltrexone also possesses immunomodulatory effects. Seen exclusively at low doses, this attribute is being employed in the pain community as a novel anti-inflammatory agent that has been shown to reduce symptom severity in fibromyalgia, Crohn's disease, multiple sclerosis, and complex regional pain syndrome.~For this study, patients enrolled in a naltrexone-containing arm will take their daily dose of the medication (4.5mg) by oral suspension."

Trial Locations (2)

55101

Regions Hospital, Saint Paul

55426

Park Nicollet Methodist Hospital, Saint Louis Park

All Listed Sponsors
collaborator

Park Nicollet Foundation

OTHER

lead

HealthPartners Institute

OTHER

NCT04756128 - Impact of Colchicine and Low-dose Naltrexone on COVID-19 | Biotech Hunter | Biotech Hunter