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

NCT ID: NCT04604704

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2023-01-23

Brief Summary

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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

Naltrexone at 4.5 mg/day

NAD+

Intervention Type: 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.

Interventions

Naltrexone

Naltrexone at 4.5 mg/day

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Low dose Naltrexone (LDN); Nicotinamide adenine dinucleotide

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+

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AgelessRx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sajad Zalzala, MD

Role: STUDY_DIRECTOR

AgelessRx

Sajad Zalzala, MD

Role: PRINCIPAL_INVESTIGATOR

AgelessRx

Locations

AgelessRx

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

ALRx004

Identifier Type: -

Identifier Source: org_study_id