Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604704
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2020-10-26
Brief Title:
Pilot Study Into LDN and NAD for Treatment of Patients With Post-COVID-19 Syndrome
Sponsor:
AgelessRx
Organization:
AgelessRx
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None