Low-dose Naltrexone for Post-COVID Fatigue Syndrome
Canada160 participantsStarted 2024-01-15
Plain-language 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 (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.
Who can participate
Age range19 Years – 69 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Pregnant, planning to become pregnant, or breastfeeding
✕. Opioid medications:
✕. A positive urine test for opioids (only for the first 16 participants)