Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome

AgelessRx

Status and phase: Completed; Phase 2

Conditions: Long COVID-19; Covid19; Post-COVID-19 Syndrome

Treatments: Drug: Naltrexone; Dietary Supplement: NAD+

Study type: Interventional

Funder types: Industry

Identifiers

NCT04604704

ALRx004

Details and patient eligibility

About

Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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+

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment with LDN and NAD+

Experimental group

Description:

LDN will be used at a dosage of 4.5 mg/day, which will be taken orally in the form of tablets. NAD+ will be administered using the IontoPatch iontophoresis patch containing 400 mg of NAD+ solution which is worn on the skin for 4-6 hours once per week.

Treatment:

Dietary Supplement: NAD+

Drug: Naltrexone