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

NCT04604704 | Completed Phase 2 FDA Drug

• 1 other identifier: ALRx004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Covid19; Long COVID-19; Post-COVID-19 Syndrome

Keywords

COVID-19; Long COVID-19; Post-COVID-19 syndrome; naltrexone; NAD; Nicotinamide adenine dinucleotide; low dose naltrexone; LDN

Outcome Measures

Primary Outcomes (1)

• Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+

  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 Outcomes (1)

• Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.

  12 weeks

Study Arms (1)

Treatment with LDN and NAD+

EXPERIMENTAL

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; Dietary Supplement: NAD+

Interventions

Naltrexone DRUG

Naltrexone at 4.5 mg/day

Also known as: Low dose Naltrexone (LDN)

Treatment with LDN and NAD+

NAD+ DIETARY_SUPPLEMENT

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.

Also known as: Nicotinamide adenine dinucleotide

Treatment with LDN and NAD+

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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+

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Naltrexone; NAD

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Sajad Zalzala, MD

  AgelessRx

  STUDY DIRECTOR

• Sajad Zalzala, MD

  AgelessRx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 27, 2020
• Study Start: January 28, 2021
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Locations

US (1)