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

Phase 2

Completed

• Conditions: Covid19; Long COVID-19; Post-COVID-19 Syndrome
• Interventions: Drug: Naltrexone; Dietary Supplement: NAD+

• Registration Number: NCT04604704
• Lead Sponsor: AgelessRx

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.

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-27
• Study Start: 2021-01-28
• Status Verified: 2023-01
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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+

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with LDN and NAD+	NAD+	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 with LDN and NAD+	Naltrexone	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AgelessRx; 🇺🇸 Ann Arbor, Michigan, United States