Official Title
Pilot Study Into Low Dose Naltrexone (LDN) and Nicotinamide Adenine Dinucleotide (NAD+) for Treatment of Patients With Post-COVID-19 Syndrome (Long-COVID19)
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.

Completed
COVID19
Long COVID-19
Post-COVID-19 Syndrome

Drug: Naltrexone

Naltrexone at 4.5 mg/day
Other Name: Low dose Naltrexone (LDN)

Dietary Supplement: NAD+

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.
Other Name: Nicotinamide adenine dinucleotide

Eligibility Criteria

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+

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
United States
Locations

AgelessRx
Ann Arbor, Michigan, United States

NCT Number
Keywords
Covid-19
Long COVID-19
Post-COVID-19 syndrome
naltrexone
NAD
Nicotinamide adenine dinucleotide
low dose naltrexone
LDN
MeSH Terms
COVID-19
Post-Acute COVID-19 Syndrome
Syndrome
Niacinamide
Naltrexone