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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604704
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
AgelessRx

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

Condition or disease Intervention/treatment Phase
Covid19 Long COVID-19 Post-COVID-19 Syndrome Drug: Naltrexone Dietary Supplement: NAD+ Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Naltrexone
Naltrexone at 4.5 mg/day
Other Name: Low dose Naltrexone (LDN)

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.
Other Name: Nicotinamide adenine dinucleotide




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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+

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604704


Contacts
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Contact: Sajad Zalzala, MD (313) 355-8657 research@agelessrx.com

Locations
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United States, Michigan
AgelessRx Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Sajad Zalzala, MD    313-355-8657    research@agelessrx.com   
Sponsors and Collaborators
AgelessRx
Investigators
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Study Director: Sajad Zalzala, MD AgelessRx
Principal Investigator: Sajad Zalzala, MD AgelessRx
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Responsible Party: AgelessRx
ClinicalTrials.gov Identifier: NCT04604704    
Other Study ID Numbers: ALRx004
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021

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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
Keywords provided by AgelessRx:
COVID-19
Long COVID-19
Post-COVID-19 syndrome
naltrexone
NAD
Nicotinamide adenine dinucleotide
low dose naltrexone
LDN
Additional relevant MeSH terms:
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COVID-19
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niacinamide
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vitamin B Complex
Vitamins
Micronutrients