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

NCT04628143 | Completed Phase 2

• 1 other identifier: A108_01CVD2013
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  up to 28 days

Secondary Outcomes (2)

• Time to recovery

  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

  Day 4, 7, 10, 14, 21 and 28

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care Treatment for COVID-19 Infection

Nafamostat + Standard of Care

EXPERIMENTAL

Nafamostat mesylate on top of standard of care

Drug: Nafamostat Mesilate

Interventions

Nafamostat Mesilate DRUG

Administered intravenously as a continuous infusion

Also known as: CKD-314

Nafamostat + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Korea Cancer Center Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

nafamostat

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dongho Kim, MD

  Korea Cancer Center Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 13, 2020
• Study Start: December 21, 2020
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-04

Locations

KR (1)