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NCT Number: NCT04604704

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

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

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Key information

Conditions

Covid19 COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long COVID-19 Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AgelessRx

Ann Arbor, Michigan, 48104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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+

Treatment and study plan

Naltrexone

Drug

Naltrexone at 4.5 mg/day

Other names: Low dose Naltrexone (LDN)

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.

Other names: Nicotinamide adenine dinucleotide

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AgelessRx

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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