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. 2022 Aug 30;61(10):1331–1343. doi: 10.1007/s40262-022-01170-x

Table 3.

Ongoing clinical trials of nafamostat mesylate in the treatment of COVID-19 patients

Trial registration, date posted, and location Study title Intervention model description Treatment Primary outcome measures Participants Status

NCT04352400

Posted April 2020

Italy

Efficacy of Nafamostat in COVID-19 Patients (RACONA Study) Prospective, double blind, randomised, placebo-controlled parallel group, on top of best standard of care Nafamostat administered by continuous infusion, placebo Time to clinical improvement 256 Recruiting

NCT04390594

Posted May 2020

Senegal

Efficacy and Safety Evaluation of Treatment Regimens in Adult COVID-19 Patients in Senegal Open-label, multicentre, randomised, parallel assignment Nafamostat (0.1–0.2 mg/kg/h), standard of care SARS-CoV-2 viral load level 186 Recruiting

JPRN-jRCTs031200026

Posted May 2020

Japan

Combination therapy of Favipiravir and Nafamostat Mesylate in Patients with COVID-19 pneumonia Randomised controlled trial Nafamostat, favipiravir, standard of care Change in patient condition on a 10-point scale from baseline to day 7 160 Recruiting

NCT04418128

KCT0005003

Posted June 2020

South Korea

Clinical Efficacy of Nafamostat Mesylate for COVID-19 Pneumonia Open-label, randomised, parallel assignment Nafamostat (0.1–0.2 mg/kg/h by continuous infusion), conventional therapy Proportion of patients with clinical improvement 84 Not yet recruiting

NCT04483960

ACTRN12620000445976

Posted July 2020

Australia

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (ASCOT ADAPT) Open-label, international multicentre, randomised Nafamostat (0.2 mg/kg/h by continuous infusion), hyperimmune globulin, enoxaparin, dalteparin, tinzaparin Death or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support 2400 (estimated) Recruiting

CTRI/2020/06/026220

Posted July 2020

India

A study to evaluate the efficacy and safety of Nafamostat Mesylate in treatment of Coronavirus infection Open-label, multicentre, randomised, parallel/crossover assignment Nafamostat (0.1 mg/kg/h for 24 h by continuous infusion for 10 days), standard of care Proportion of patients showing clinical improvement by day 14 40 Completed

NCT04628143

Posted November 2020

South Korea

A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia Open-label, multicentre, randomised, parallel assignment Nafamostat administered by continuous infusion, standard of care Time to clinical improvement 13 Completed

JPRN-jRCTs031210183

Posted July 2021

Japan

Exploratory research of nafamostat mesylate in early mild COVID-19 patients Open-label, randomised, parallel assignment Nafamostat (0.1 or 0.2 mg/kg/h for 6 days), standard treatment AUC of SARS-CoV-2 virus reduction in the nasopharynx from before the start of treatment to the 6th day of treatment 30 Recruiting

COVID-19 coronavirus disease 2019, SARS-CoV-2 severe acute respiratory syndrome coronavirus-2