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

NCT ID: NCT04628143

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2021-04-05

Brief Summary

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

Detailed 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

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of Care Treatment for COVID-19 Infection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nafamostat + Standard of Care

Nafamostat mesylate on top of standard of care

Group Type: EXPERIMENTAL

Nafamostat Mesilate

Intervention Type: DRUG

Administered intravenously as a continuous infusion

Interventions

Nafamostat Mesilate

Administered intravenously as a continuous infusion

Intervention Type: DRUG

Other Intervention Names

CKD-314

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dongho Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Korea Cancer Center Hospital

Locations

Korea Cancer Center Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A108_01CVD2013

Identifier Type: -

Identifier Source: org_study_id