Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
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|ClinicalTrials.gov Identifier: NCT04604704|
Recruitment Status : Active, not recruiting
First Posted : October 27, 2020
Last Update Posted : September 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Long COVID-19 Post-COVID-19 Syndrome||Drug: Naltrexone Dietary Supplement: NAD+||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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)|
|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 :||November 2022|
|Estimated Study Completion Date :||November 2022|
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.
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
- 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.
- 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.
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
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48104|
|Study Director:||Sajad Zalzala, MD||AgelessRx|
|Principal Investigator:||Sajad Zalzala, MD||AgelessRx|