Low-dose Naltrexone for Post-COVID Fatigue Syndrome

Launched by LUIS NACUL · Jun 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether low-dose naltrexone (LDN) can help people who are experiencing fatigue and other symptoms after having COVID-19, known as Post-COVID Fatigue Syndrome. The trial aims to find out if taking LDN can reduce fatigue, improve symptoms, and lower certain markers of inflammation in the blood. LDN is a medication that is considered safe and may help with pain and inflammation. The trial is being conducted at BC Women's Hospital and is currently looking for participants.

To be eligible for the study, you need to be between 19 and 70 years old, have had a confirmed case of COVID-19 at least three months ago, and meet the criteria for Post-COVID Fatigue Syndrome. It's important that you are not pregnant, breastfeeding, or taking certain medications like opioids. If you join the trial, you will be asked to keep taking any other medications you currently use at the same dose throughout the study. Participants may need to stop using opioid medications for a short time before the trial starts. The trial will help determine if LDN could be a beneficial treatment for many people suffering from this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients ages 19 to less than 70 years
• • 2. Case of SARS-CoV-2 over 3 previously, confirmed by a positive test result or clinical confirmation by a physician
• • 3. Meet the clinical diagnostic criteria for PCFS
• • 4. 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)
• • 5. Agree to use effective contraception for the trial duration, as appropriate, if female.
• • 6. The participant resides within the delivery area for the drug as determined by FedEx Clinical Trial Services
• Exclusion Criteria:
• • 1. Pregnant, planning to become pregnant, or breastfeeding
• 2. Opioid medications:
• • Any use within last 15 days, as reported by the patient
• • During the trial
• • 3. A positive urine test for opioids (only for the first 16 participants)
• • 4. History of alcohol, opioid or other substance misuse
• • 5. Participation in another interventional clinical trial in the last 30 days or planned during the trial period
• • 6. Confirmed ME/CFS or FM existing prior to SARS-CoV-2 infection
• • 7. Allergy to naltrexone or medication components
• • 8. Acute hepatitis, liver failure, or severe kidney failure.
• • 9. Current or recent use of naltrexone in the last 30 days
• • 10. 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.