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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT04604704 (opens ClinicalTrials.gov in a new tab)Other idALRx004
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Overview

Status
Completed
Phase
Phase 2
Enrollment
36 participants (actual)
Sponsor
AgelessRx · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
28 Jan 2021
Primary completion
23 Jan 2023
Completion
23 Jan 2023
First posted
27 Oct 2020
Last update posted
25 Jan 2023
Conditions
Covid19 · Long COVID-19 · Post-COVID-19 Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2

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

    NCT04604704

    28 Jan 2021 to 23 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • NaltrexoneDrug
  • NAD+Dietary supplement

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 12 weeks

    Registry description

    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)

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

    Time frame · 12 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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+

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