Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352400
Status:
RECRUITING
Last Update Posted:
2023-11-01
First Post:
2020-04-03
Brief Title:
Efficacy of Nafamostat in Covid-19 Patients RACONA Study
Sponsor:
University Hospital Padova
Organization:
University Hospital Padova
Study Overview
Official Title:
RAndomized Clinical Trial in COvid19 Patients to Assess the Efficacy of the Transmembrane Protease Serine 2 TMPRSS2 Inhibitor NAfamostat RACONA Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
RACONA
Brief Summary:
RACONA is a prospective trial that will test the hypothesis that nafamostat can lower lung function deterioration and need for intensive care admission in COVID-19 patients
Design Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate administered intravenously on top of best standard of care
Primary outcome measures the time-to-clinical improvement defined as the time from randomization to an improvement of two points from the status at randomization on a seven category ordinal scale or live discharge from the hospital whichever comes first
Design Adult hospitalized COVID-19 patients will be randomized in a prospective double-blind randomized placebo-controlled study to test the clinical efficacy of nafamostat mesylate administered intravenously on top of best standard of care
Primary outcome measures the time-to-clinical improvement defined as the time from randomization to an improvement of two points from the status at randomization on a seven category ordinal scale or live discharge from the hospital whichever comes first
Detailed Description:
Purpose SARS-Cov-2 enters the lung cells by binding to ACE-2 and activating the protease TMPRSS2 which therefore can be a target for antiviral treatment Accordingly TMPRSS2 inhibitors prevent SARS-CoV cell entry in vitro The most potent such inhibitors nafamostat is being used as anticoagulant and anti-pancreatitis agent and is approved for the treatment of cystic fibrosis as its mucolytic action can prevent lung function deterioration by owering airways infections
RACONA study will test the hypothesize that nafamostat is useful in COVID-19 lung involvement because COVID-19 entails activation of the coagulation cascade pulmonary embolism and bacterial superinfections
RACONA study will test the hypothesize that nafamostat is useful in COVID-19 lung involvement because COVID-19 entails activation of the coagulation cascade pulmonary embolism and bacterial superinfections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None