Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04604678
Status:
WITHDRAWN
Last Update Posted:
2022-10-04
First Post:
2020-10-26
Brief Title:
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
Sponsor:
AgelessRx
Organization:
AgelessRx
Study Overview
Official Title:
Pilot Study Into the Use of Metformin and Low Dose Naltrexone LDN for Patients With Coronavirus Disease 2019 COVID-19 - Assessment of Short and Long Term Effects
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants due to restrictive inclusionexclusion criteria Will update protocol with IRB begin anew after approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study into the effects of daily use of metformin and low-dose naltrexone LDN for 4 weeks to reduce symptoms disease severity and recovery time from COVID-19
Detailed Description:
The researchers will treat 40 patients with metformin 1500 mgday and LDN 45 mgday for 4 weeks to reduce symptoms disease severity and recovery time from COVID-19 These 40 patients will be compared with 40 control patients who will receive regular care All patients will be asked to complete surveys at baseline and after 1 2 and 4 weeks after initiation of treatment The difference with baseline at each time point will be assessed The surveys will assess COVID-19 symptoms severity
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