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

COVID-19 Clinical Trial

Official title:

An Open-label, Randomized, Multicenter, Controlled Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623021
• Other study ID #: A108_02CVD2014
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: January 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• 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:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• Pneumonia

Intervention

Drug:
• Nafamostat Mesilate
Administered intravenously as a continuous infusion

Locations

Country	Name	City	State
Russian Federation	A108_02CVD2014 Site# 9	Barnaul
Russian Federation	A108_02CVD2014 Site# 26	Krasnoyarsk
Russian Federation	A108_02CVD2014 Site# 5	Moscow
Russian Federation	A108_02CVD2014 Site# 8	Moscow
Russian Federation	A108_02CVD2014 Site# 31	Ryazan
Russian Federation	A108_02CVD2014 Site# 25	St. Petersburg
Russian Federation	A108_02CVD2014 Site# 29	St. Petersburg
Russian Federation	A108_02CVD2014 Site# 3	St. Petersburg
Russian Federation	A108_02CVD2014 Site# 30	St. Petersburg
Russian Federation	A108_02CVD2014 Site# 4	St. Petersburg
Russian Federation	A108_02CVD2014 site#1	Ufa

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Russian Federation, 

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		Day 4, 7, 11, 14 and 28
Secondary	Proportion of patients with recovery as defined as 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	Day 4, 7, 11, 14 and 28
Secondary	Change of clinical status assessed by 7-category ordinal scale		Day 4, 7, 11, 14 and 28
Secondary	Change in National Early Warning Score (NEWS)		Day 4, 7, 11, 14 and 28
Secondary	Time to National Early Warning Score (NEWS) of = 2 which is maintained for 24 hours		up to 28 days
Secondary	Changes on CT scan/X-ray	Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray	Day 5, 11, 14 and 28
Secondary	Change from baseline of CRP		Day 4, 7, 11, 14 and 28
Secondary	Time to normalize the CRP	Decrease to the level of <10 mg/l	up to 28 days
Secondary	Duration of hospitalization		up to 28 days
Secondary	Duration of non-invasive ventilation or high flow oxygen use		up to 28 days
Secondary	Incidence of non-invasive ventilation or high flow oxygen use	Proportion of patients of non-invasive ventilation or high flow oxygen use	up to 28 days
Secondary	Duration of supplement oxygen use		up to 28 days
Secondary	Incidence of supplement oxygen use	Proportion of patients of supplement oxygen use	up to 28 days
Secondary	Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use		up to 28 days
Secondary	Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use	Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use	up to 28 days
Secondary	28-Day mortality		up to 28 days