Status:
RECRUITING
Low-dose Naltrexone for Post-COVID Fatigue Syndrome
Lead Sponsor:
Luis Nacul
Collaborating Sponsors:
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Conditions:
Post-Viral Fatigue Syndrome
Eligibility:
All Genders
19-69 years
Phase:
PHASE2
Brief Summary
This study aims to determine if low-dose naltrexone (LDN) reduces fatigue, improves related symptoms, and reduces inflammatory markers in peripheral blood in cases with Post-COVID-19 Fatigue Syndrome ...
Detailed Description
There is a growing number of individuals who do not recover to previous levels of health and function following an acute infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but ...
Eligibility Criteria
Inclusion
- Male and female patients ages 19 to less than 70 years
- Case of SARS-CoV-2 over 3 previously, confirmed by a 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.
- The participant resides within the delivery area for the drug as determined by FedEx Clinical Trial Services
Exclusion
- Pregnant, planning to become pregnant, or breastfeeding
- Opioid medications:
- Any use within last 15 days, as reported by the patient
- During the trial
- A positive urine test for opioids (only for the first 16 participants)
- 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, liver failure, or severe kidney failure.
- Current or recent use of naltrexone in the last 30 days
- The participant is not an ideal candidate for the study, in the opinion of the investigator, for any other reason (ie. personal or logistic, medication, condition, etc.) that could impact the participant's safety or the results of the study.
- Opioid Washout Period:
- Potential participants who are currently taking opioid medications who wish to enrol the study will be instructed they can stop taking opioid medications for 15 days before continuing the screening process. They will be instructed that they should speak with their family doctor before stopping any prescribed medications.
- Positive Urine Test for Opioids:
- As regular use of opioid medications is an exclusion criterion, we will do a quality control check with the first 16 participants to test for the presence of opioids in their urine. Any participants with a positive test, will be excluded from the study, and such finding will be discussed at the Trial Steering Committee or DSMB for potential trial modification.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 16 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05430152
Start Date
January 15 2024
End Date
August 16 2025
Last Update
February 3 2025
Active Locations (1)
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1
Women's Health Research Institute
Vancouver, British Columbia, Canada, V6H 3N1