A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19

Kim et al., NCT04871646, NCT04871646, Aug 2022

Estimated 586 patient nafamostat late treatment RCT with results not reported over 3 years after estimated completion.

4 nafamostat RCTs have results missing long after expected1-4
The trials report a total of 742 patients, with 2 trials having actual enrollment of 72, and the remainder estimated.

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Study covers TMPRSS2 inhibitors and nafamostat.

1. Seydi et al., Multicentre, Open Label, Randomised, Adaptative Clinical Trial of Efficacy and Safety of Treatment Regimens in Adult COVID-19 Patients in Senegal, NCT04390594, clinicaltrials.gov/study/NCT04390594clinicaltrials.gov.

2. Kim et al., A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19, NCT04871646, clinicaltrials.gov/study/NCT04871646clinicaltrials.gov.

3. Bae et al., Treatment Effect of Nafamostat Mesylate in Patients With COVID-19 Pneumonia: Open Labelled Randomized Controlled Clinical Trial, NCT04418128, clinicaltrials.gov/study/NCT04418128clinicaltrials.gov.

4. Kim (B) et al., Open-label, Multi-center, Randomized Controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19, NCT04628143, clinicaltrials.gov/study/NCT04628143clinicaltrials.gov.

Kim et al., 1 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, South Korea, trial NCT04871646 (history). Contact: dasom@ckdpharm.com.

Late treatment
is less effective