A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia

Chong Kun Dang

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Drug: Nafamostat Mesilate

Study type

Interventional

Funder types

Industry

Identifiers

NCT04628143

A108_01CVD2013

Details and patient eligibility

About

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

Full description

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

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women Aged ≥18 years
Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:
- COVID-19 infection: SARS-CoV-2 positive confirmed by RT-PCR
  - Pneumonia: A reliable diagnosis of new lung infiltration on a chest CT scan or chest radiograph
Subjects within 72 hours after confirmed COVID-19 pneumonia
Subjects with a seven-category ordinal scale of clinical status of 4 (hospitalization, requiring supplemental oxygen) or 5 (hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation)
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

Exclusion criteria

Subject has a serious chronic disease
Subject requiring invasive mechanical ventilation at the time of screening
Subject with rapidly(within 3 days) deteriorating clinical condition according to the investigator's opinion
Subject who have a record of HIV or AIDS
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]
Subject taking immunosuppressants/immunomodulators
Subject with liver cirrhosis whose Child-Pugh score is B or C
Subject with hyperkalemia (K> 5.1mmol/L)
Subject who have liver disease abnormalities with ALT or AST > 5 times ULN
Estimated glomerular filtration rate (eGFR) < 30 ml/min
QTc >500ms
Subject who have hypersensitivity to the investigational drug
Pregnant or lactating females
Subject who are not appropriate for the study, as the investigator's opinion