COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04623021

Chong Kun Dang Pharmaceutical

hky1@ckdpharm.com

2020-11-10

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - men and women aged ≥18 years - hospitalized subjects who have confirmed covid-19 infection and have evidence of pneumonia: - subjects who are eligible for diagnosis/evaluation to chest x-ray or chest ct - women of childbearing potential (including women in post menopause for less than 2 years) must use a medically acceptable forms of birth control and agree to continue its use during the study - subjects (or legally authorized representative) should be able to understand and agree to comply with the clinical trial and to provide a written consent document prior to initiation of any study procedure

- subjects who have a record of hiv or aids - subject has a serious chronic disease - active bleeding or ongoing clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment - pregnant or lactating females - subjects with liver cirrhosis whose child-pugh score is b or c - subjects who have liver disease abnormalities with alt or ast > 5 times uln - estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration) - qtcb or qtcf >500ms - subjects who have clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation) in medical history - subjects with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator's opinion - subjects who are not appropriate for the study, as the investigator's opinion - subjects who have hypersensitivity to the investigational drug - subjects participated in any other clinical trial (including drugs for the treatment of covid-19) 3 months prior to screening

2

Chong Kun Dang Pharmaceutical

18

100

Russia

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

104

Time to clinical improvement

None

Phase 2

[{"arm_notes": "", "treatment_id": 854, "treatment_name": "Nafamostat mesilate", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]