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

January 23, 2023 updated by: AgelessRx

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • AgelessRx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AgelessRx

Investigators

  • Study Director: Sajad Zalzala, MD, AgelessRx
  • Principal Investigator: Sajad Zalzala, MD, AgelessRx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

January 23, 2023

Study Completion (Actual)

January 23, 2023

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALRx004

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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