Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
Updated: Feb 1, 2022

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Tracking Information
First Submitted Date: October 26, 2020
First Posted Date: October 27, 2020
Last Update Posted Date: March 3, 2021
Actual Study Start Date: January 28, 2021
Estimated Primary Completion Date: August 2021
(Final data collection date for primary outcome measure)
Current Primary Outcome Measures (submitted: October 26, 2020)
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
[ Time Frame: 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.
Original Primary Outcome Measures (submitted: October 26, 2020)
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+ [ Time Frame: 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+.
Change History Current Secondary Outcome Measures: (submitted: October 26, 2020)
Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+. [ Time Frame: 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.
Original Secondary Outcome Measures (submitted: October 26, 2020)
Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+. [ Time Frame: 12 weeks ]
Improvement of quality of life scores from baseline as measured by the SF-36 survey in post-COVID-19 syndrome by treatment with LDN and NAD+.
Current Other Pre-specified Outcome Measures- Not Provided
Original Other Pre-specified Outcome Measures-Not Provided
Descriptive InformationBrief Title: Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
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 double-blind placebo-controlled 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 or a corresponding placebo tablet and patch (control group) 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 Type: Interventional
Study Phase : Phase 2
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients will receive LDN and NAD+ treatment or a corresponding placebo tablet and patch 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: Double (Participant, Care Provider)
Primary Purpose: Treatment
Conditions:
Covid19
Long COVID-19
Post-COVID-19 Syndrome
Intervention ICMJE
Drug: NaltrexoneNaltrexone 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
Other: Placeboplacebo tablet and patch
Study Arms ICMJE
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. Interventions:
Drug: Naltrexone
Dietary Supplement: NAD+
Placebo Comparator: Control groupPatients will receive a corresponding placebo tablet and patch for 12 weeks. Intervention: Other: Placebo
Publications *Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov
Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment (submitted: October 26, 2020): 60
Original Estimated Enrollment Same as current
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
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+
Sex/Gender
Sexes Eligible for Study:All
Ages :18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers :No
Contacts
Contact: Sajad Zalzala, MD (313) 355-8657 research@agelessrx.com
Listed Location Countries: United States
Removed Location Countries
Administrative Information
NCT Number : NCT04604704
Other Study ID Numbers :LRx004
Has Data Monitoring Committee: No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
Product Manufactured in and Exported from the U.S.:No
IPD Sharing Statement: Not Provided
Responsible Party: AgelessRx
Study Sponsor: AgelessRx
Collaborators: Not Provided
Investigators
Study Director:Sajad Zalzala, MD, AgelessRx
Principal Investigator:Sajad Zalzala, MD AgelessRx
PRS AccountAgelessRx
Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP