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

Sponsor

AgelessRx (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04604704

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Long COVID-19 Post-COVID-19 Syndrome	Drug: Naltrexone Dietary Supplement: NAD+	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jan 28, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with LDN and 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.	Drug: Naltrexone Naltrexone at 4.5 mg/day Other Names: 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 Names: Nicotinamide adenine dinucleotide

Arm

Intervention/Treatment

Experimental: Treatment with LDN and 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.

Drug: Naltrexone

Naltrexone at 4.5 mg/day

Other Names:

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 Names:

Nicotinamide adenine dinucleotide

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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+