Clinical trial NCT04604704: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: AgelessRx
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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+

Primary outcomes:
measure: Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: AgelessRx
state: Michigan
Study officials:
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: STUDY_DIRECTOR
affiliation: AgelessRx
name: Sajad Zalzala, MD
role: PRINCIPAL_INVESTIGATOR
References: