Back to resultsPilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
Primary Purpose
Covid19, Long COVID-19, Post-COVID-19 Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
NAD+
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Long COVID-19, Post-COVID-19 syndrome, naltrexone, NAD, Nicotinamide adenine dinucleotide, low dose naltrexone, LDN
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+
Sites / Locations
- AgelessRx
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with LDN and NAD+
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04604704
Brief Title
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
January 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AgelessRx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with LDN and NAD+
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Low dose Naltrexone (LDN)
Intervention Description
Naltrexone at 4.5 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
NAD+
Other Intervention Name(s)
Nicotinamide adenine dinucleotide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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+
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajad Zalzala, MD
Organizational Affiliation
AgelessRx
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sajad Zalzala, MD
Organizational Affiliation
AgelessRx
Official's Role
Principal Investigator
Facility Information:
Facility Name
AgelessRx
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
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