Low-dose Naltrexone for Post-COVID Fatigue Syndrome
Post-Viral Fatigue Syndrome
About this trial
This is an interventional treatment trial for Post-Viral Fatigue Syndrome focused on measuring Post-COVID Fatigue Syndrome, Long-COVID, COVID-19, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- Male and female patients ages 19 to less than 70 years
- Case of SARS-CoV-2, between 3 and 6 months previously, accepted by the PCRC based on positive test result or clinical confirmation by a physician
- Meet the clinical diagnostic criteria for PCFS
- Agree to maintain any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician)
- Agree to use effective contraception for the trial duration, as appropriate, if female.
Exclusion Criteria:
- Pregnant, planning to become pregnant, or breastfeeding
Any use of opioid medications:
- Within last 15 days, as reported by the patient (or recorded in clinical system used by PCRC clinician)
- During the trial
- A positive urine test for opioids (only for the first 16 participants; see below)
- History of alcohol, opioid or other substance misuse
- Participation in another interventional clinical trial in the last 30 days or planned during the trial period
- Confirmed ME/CFS or FM existing prior to SARS-CoV-2 infection
- Allergy to naltrexone or medication components
- Acute hepatitis or liver failure
- Current or recent use of naltrexone in the last 30 days
Sites / Locations
- BC Women's Hospital + Health Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Low-Dose Naltrexone
Placebo
The Low-Dose Naltrexone (LDN) will be provided as a compounded capsule starting at a strength of 1mg/day of naltrexone and increasing up to a maximum of 4.5 mg/day. The compounding pharmacy will compound the needed doses in Capsugel® empty gelatin based capsules using Naltrexone Hydrochloride Tablets and CELLULOSE.
Matching placebo capsule will be created by compounding pharmacy to look exactly like the LDN doses. The compounding pharmacy will compound the placebo in Capsugel® empty gelatin based capsules using CELLULOSE.