Low-dose Naltrexone for Post-COVID Fatigue Syndrome

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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) in the past 3-6 months. 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 the Post-COVID Recovery Clinics (PCRC) in British Columbia and will demonstrate whether LDN could benefit a large number of people with PCFS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luis Nacul
• Collaborators: BC Women's Hospital & Health Centre; Canadian Institutes of Health Research (CIHR); Fraser Health; Providence Health & Services; Provincial Health Services Authority; University of British Columbia; Vancouver Coastal Health
• Treatments: Naltrexone

Criteria

Inclusion Criteria:

1. Male and female patients ages 19 to less than 70 years

2. 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

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.

Exclusion Criteria:

1. Pregnant, planning to become pregnant, or breastfeeding

2. 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

3. A positive urine test for opioids (only for the first 16 participants; see below)

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 or liver failure

9. Current or recent use of naltrexone in the last 30 days