drugset / Trial / NCT05430152
Low-dose Naltrexone for Post-COVID Fatigue Syndrome
Phase 2
Completed
160 enrolled
Luis Nacul
Canadian Institutes of Health Research (CIHR) · collabProvincial Health Services Authority British Columbia · collabUniversity of British Columbia · collabWomen's Health Research Institute of British Columbia · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-01-15
- Primary completion
- 2026-02-15
- Completion
- 2026-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 4.5 mg | Oral |