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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04604704
• Other study ID #: ALRx004
• Status: Completed
• Phase: Phase 2
• Start date: January 28, 2021
• Est. completion date: January 23, 2023

Study information

• Verified date: January 2023
• Source: AgelessRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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+

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Long COVID-19
• Post-COVID-19 Syndrome
• Syndrome

Intervention

Drug:
• Naltrexone
Naltrexone at 4.5 mg/day

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.

Locations

Country	Name	City	State
United States	AgelessRx	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
AgelessRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.	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