Covid19, Long COVID-19, Post-COVID-19 Syndrome
Conditions
Keywords
COVID-19, Long COVID-19, Post-COVID-19 syndrome, naltrexone, NAD, Nicotinamide adenine dinucleotide, low dose naltrexone, LDN
Brief summary
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.
Detailed description
This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19). Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included. Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue since positive test. Patients will be screened using the fatigue survey and cases with a moderate to severe score will be included. Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality of life will be assessed using validated surveys. Surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of scores from baseline levels will be assessed.
Interventions
DRUGNaltrexone
Naltrexone at 4.5 mg/day
DIETARY_SUPPLEMENTNAD+
NAD+ will be applied using iontophoresis patches. The patches will be provided by ready-made NAD+ solutions (400 mg) to be applied to the positive electrode of the patch and saline to the negative electrode. The patch is powered by a self-contained battery, producing an electric current to facilitate NAD+ absorption through the skin into the blood. Patches are worn for 4-6 hours once a week.
Sponsors
AgelessRx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will receive LDN and NAD+ treatment for 12 weeks. The researchers will assess fatigue and quality of life using validated surveys. Surveys will be conducted at baseline (at time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. Improvement of scores from baseline levels will be determined.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Any ethnicity * Adequate cognitive function to be able to give informed consent * Technologically competent to complete web forms and perform video calls with the PI * Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment * A fatigue score above 9 in the Chalder Fatigue scale upon enrollment * Willing to fill out regular questionnaires * Willing to use LDN and NAD patches
Exclusion criteria
* Clinically significant kidney, heart, Hepatic impairment as determined by clinical judgement * Taking opioid analgesics, or undergoing treatment for opioid addiction * Opioid dependence or withdrawal syndrome * Known sensitivity to naltrexone * Suspected or confirmed pregnancy or breastfeeding * Known issues with using iontophoresis patches * Active cancers * Enrolled in another trial * Current users of LDN or NAD+
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+ | 12 weeks | Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+. | 12 weeks | Improvement of quality of life scores from baseline as measured by the short form-36 (SF-36) survey in post-COVID-19 syndrome by treatment with LDN and NAD+. The SF-36 survey provides scores between 0-100 with lower scores representing more disability. |
Countries
United States
Outcome results
None listed