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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628143
• Other study ID #: A108_01CVD2013
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2020
• Est. completion date: April 5, 2021

Study information

• Verified date: April 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ? steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ? topical steroids,

? 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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Nafamostat Mesilate
Administered intravenously as a continuous infusion

Locations

Country	Name	City	State
Korea, Republic of	Korea Cancer Center Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	up to 28 days
Secondary	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	Day 4, 7, 10, 14, 21 and 28