Efficacy of Nafamostat in Covid-19 Patients (RACONA Study) (RACONA)
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|ClinicalTrials.gov Identifier: NCT04352400|
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : June 9, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|COVID19||Drug: Nafamostat Mesilate Drug: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double blind, placebo-controlled parallel-group trial, on top of best standard of care|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Randomization will be done with an algorithm tailored to the study design. Investigators and patients will be blinded to the treatment administered.|
|Official Title:||RAndomized Clinical Trial in COvid19 Patients to Assess the Efficacy of the Transmembrane Protease Serine 2 (TMPRSS2) Inhibitor NAfamostat (RACONA Study)|
|Actual Study Start Date :||June 4, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Nafamostat
Nafamostat mesylate on top of best standard of care.
Drug: Nafamostat Mesilate
administered intravenously as a continuous infusion
Other Name: no alternative name. Commercial brands are available.
Placebo Comparator: Placebo
Placebo on top of best standard of care.
administered intravenously as a continuous infusion
Other Name: no alternative name.
- Time-to-clinical improvement [ Time Frame: day 1 until day 28 ]Time-to-clinical improvement (time from randomization to an improvement of two points (from the status at randomization) on a 7 category ordinal scale or live discharge from the hospital, whichever came first.
- Responders [ Time Frame: day 1 until day 28 ]Rate of patients showing improvement of 2 points in 7 category ordinal scale (with 7 points the worst)(PubMed ID: 32187464)
- Critical or dead patients [ Time Frame: day 1 until day 28 ]Proportion of patients who will progress to critical illness/death
- pO2/FiO2 ratio [ Time Frame: day 1 until day 28 ]Change in pO2/FiO2 ratio over time
- SOFA score over time [ Time Frame: day 1 until day 28 ]Change Sequential organ failure assessment score (SOFA score) over time. The Score ranges from 0 to 24 (with 24 the worst)(PubMed ID: 11594901)
- Hospitalization [ Time Frame: day 1 until day 28 ]Duration of hospitalization in survivors (days)
- Mechanical ventilation [ Time Frame: day 1 until day 28 ]Number of patients who require ventilation
- Mechanical ventilation duration [ Time Frame: day 1 until day 28 ]Duration of ventilation (days)
- Cardiovascular disease [ Time Frame: day 1 until day 28 ]Proportion of patients who develop arrhythmia, or myocardial infarction, or other cardiovascular disease not present at the baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352400
|Contact: Gian Paolo Rossi, Prof.||0039049821 ext email@example.com|
|Azienda Ospedale Università di Padova||Recruiting|
|Padova, Italy, 35128|
|Contact: Gian Paolo Rossi, Prof.|
|Sub-Investigator: Andrea Vianello, MD|
|Sub-Investigator: Gabriella Guarnieri, MD|
|Sub-Investigator: Sara Lococo, MD|
|Sub-Investigator: Beatrice Molena, BSc|
|Principal Investigator: Paola Fioretto, MD|
|Sub-Investigator: Filippo Farnia, MD|
|Sub-Investigator: Federico Capone, MD|
|Principal Investigator: Annamaria Cattelan, MD|
|Sub-Investigator: Maria Mazzitelli, MD|
|Principal Investigator:||Gian Paolo Rossi, Prof.||University of Padova, Italy|