A Double Blind Randomized Trial of Low-dose Naltrexone for Post-COVID Fatigue Syndrome

H21-02254

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 (PCFS) from COVID-19 (i.e. confirmed SARS-CoV-2 case). LDN refers to naltrexone given in doses of 1-4.5 mg. Overall, studies have found that LDN is safe and well-tolerated. It may help to reduce pain and inflammation and improve well-being and immune function.The trial will be conducted by the Complex Chronic Diseases Program (CCDP) at BC Women's Hospital and will demonstrate whether LDN could benefit a large number of people with PCFS.

2024-01-15

2024-12-01

2024-12-01

Recruiting

Early phase I

160

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.

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2024-03-01