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Naltrexone-Only Arm for Coronavirus (COLTREXONE Trial)

Phase 2
Waitlist Available
Led By Dan Delaney, PharmD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from time of hospitalization until (1) 5 days after enrollment, while still hospitalized (or until discharge, which may be less than 5 days)
Awards & highlights

Summary

This trial is testing colchicine and low-dose naltrexone (LDN) to see if they can prevent COVID-19 from worsening in hospitalized patients. Colchicine helps reduce inflammation and may stop the virus from spreading, while LDN boosts the immune system and prevents it from overreacting. The goal is to see if these medications can help patients avoid severe illness and complications.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from time of hospitalization until (1) 5 days after enrollment, while still hospitalized (or until discharge, which may be less than 5 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from time of hospitalization until (1) 5 days after enrollment, while still hospitalized (or until discharge, which may be less than 5 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In Patients Hospitalized With Moderate COVID-19, the Impact of Colchicine and LDN, Alone or in Combination, on Achieving Disease Recovery by Day 5.
Secondary outcome measures
In Patients Hospitalized With Moderate COVID-19, Patients Who Required ICU or ICU Stepdown Cares
In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Corticosteroids
In Patients Hospitalized With Moderate COVID-19, Subjects Who Required Remdesivir
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Naltrexone-Only ArmExperimental Treatment1 Intervention
Patients randomized to an LDN-containing treatment arm (including the "combined arm") will receive naltrexone 4.5 mg once daily. The first dose can be given at any time during the day of enrollment/randomization, and will be timed at 08:00 daily thereafter (with AM colchicine dose, if in combined colchicine/LDN arm) for up to 28 days (unless new contraindication or exclusion criteria met). Patients in this arm will also receive the investigating institution's current standard of care (described in detail in the "standard of care" arm) for patients with COVID-19.
Group II: Colchicine-Only ArmExperimental Treatment1 Intervention
Patients randomized to a colchicine-containing treatment arm will receive colchicine 0.6 mg twice daily for up to 28 days. On the day of enrollment, provided the first dose can be given prior to 16:00 that day, patients are eligible to receive two doses; the second dose will be scheduled for 22:00. Patients experiencing gastrointestinal side effects (nausea, vomiting, and diarrhea) on twice daily dosing may have the dose decreased to 0.6 mg daily. Dosing will continue twice daily unless there is a change that requires a dose adjustment or an exclusion criterion is met. Dosing deviations above the study protocol will be allowed if medically necessary for the treatment of an additional indication (e.g. colchicine for viral pericarditis). Patients in this arm will also receive the investigating institution's current standard of care (described in detail in the "standard of care" arm) for patients with COVID-19.
Group III: Colchicine and Naltrexone ("Combined") ArmExperimental Treatment2 Interventions
Patients randomized to a colchicine-containing treatment arm (including the "combined arm") will receive colchicine 0.6 mg twice daily for up to 28 days. On the day of enrollment, provided the first dose can be given prior to 16:00 that day, patients are eligible to receive two doses; the second dose will be scheduled for 22:00. Patients in the "combined" arm will also receive naltrexone. Patients randomized to an LDN-containing treatment arm (including the "combined arm") will receive naltrexone 4.5 mg once daily. The first dose can be given at any time during the day of enrollment/randomization, and will be timed at 08:00 daily thereafter (with AM colchicine dose, if in combined colchicine/LDN arm) for up to 28 days (unless new contraindication or exclusion criteria met). Patients in this arm will also receive the investigating institution's current standard of care (described in detail in the "standard of care" arm) for patients with COVID-19.
Group IV: Standard of Care ArmActive Control1 Intervention
Patients in this arm will receive the investigating institution's current standard of care for patients with COVID-19. For example, all patients requiring supplemental oxygen (assuming no contraindications) would be candidates for both remdesivir 200 mg x 1 IV dose followed the next day by 100 mg q24h IV x up to 4 doses, as well as dexamethasone 6 mg q24h x 10 up to 10 doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved
Colchicine
FDA approved

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor
187 Previous Clinical Trials
3,661,322 Total Patients Enrolled
Park Nicollet FoundationOTHER
5 Previous Clinical Trials
650 Total Patients Enrolled
Dan Delaney, PharmDPrincipal InvestigatorPark Nicollet Methodist Hospital
~31 spots leftby Sep 2025
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