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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.

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