A Phase 2 interventional study of Nafamostat Mesilate in COVID-19, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-13.
Sponsored by Chong Kun Dang Pharmaceutical · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of CKD-314 (Nafabelltan) compared to standard of care (SOC), with respect to clinical status assessed by a 7-point ordinal scale in hospitalized adult patients diagnosed with COVID-19 pneumonia
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
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 13 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:
COVID-19 infection: SARS-CoV-2 positive confirmed by RT-PCR
Exclusion Criteria:
Subject taking corticosteroids[However, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids,
③ Patients who are administering inhaled steroids are not eligible for exclusion]
Standard of Care Treatment for COVID-19 Infection
Nafamostat mesylate on top of standard of care
Drug: Nafamostat Mesilate
Administered intravenously as a continuous infusion
Also known as: CKD-314
Time to clinical improvement
Time to clinical improvement (TTCI) was defined as time (days) from randomization to a decline of 2 categories on the seven-category ordinal scale of clinical status or live discharge from the hospital, whichever came first
Time frame: up to 28 days
Time to recovery
Day of recovery is defined as the first day on which the subject satisfies one of the following: 1) Not hospitalized with resumption of normal activities; 2) Not hospitalized, but unable to resume normal activities; 3) Hospitalization, not requiring supplemental oxygen- no longer required ongoing medical care
Time frame: up to 28 days
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status
Proportion of patients with clinical improvement as defined by live discharge from hospital or a decline of 2 categories on the seven-category ordinal scale of clinical status
Time frame: Day 4, 7, 10, 14, 21 and 28
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Chong Kun Dang Pharmaceutical