Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530474
Status:
WITHDRAWN
Last Update Posted:
2021-05-26
First Post:
2020-08-26
Brief Title:
Outpatient Use of Ivermectin in COVID-19
Sponsor:
Temple University
Organization:
Temple University
Study Overview
Official Title:
Outpatient Use of Ivermectin in COVID-19
Status:
WITHDRAWN
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
WHO report
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Covid 19 a novel coronavirus causes infection that while mild to moderate in many people can lead to severe disease in a significant portion Currently it is expected that the majority 81 of patients with COVID-19 will have mild to moderate disease with 14 having more severe disease 2 There exists a number of candidate drugs that may inhibit SARS-CoV-2 infection or progression of disease Simple safe and low-cost strategies that may be the best solution to inhibit infection and limit transmission and spread of infection
Ivermectin is a drug initially synthesized and used as an anthelmintic It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin αβ-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours A recent multi-continent retrospective study of 1400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 14 versus 85 Given these findings and its safety profile cost and ease of administration Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection
Ivermectin is a drug initially synthesized and used as an anthelmintic It has been found to have activity against several RNA viruses such as the SARS-CoV-2 by mechanisms that inhibit importin αβ-mediated nuclear transport that may prevent viral proteins from entering the nucleus to alter host cell function A recent in vitro study showed that a single dose of ivermectin could kill COVID-19 in vitro within 48 hours A recent multi-continent retrospective study of 1400 patients demonstrated an association of ivermectin use with lower in-hospital mortality 14 versus 85 Given these findings and its safety profile cost and ease of administration Ivermectin warrants study as a potential treatment to prevent progression of COVID 19 infection
Detailed Description:
None
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