Clinical trial NCT04623021: A Study Evaluating the Efficacy and Safety of CKD-314 (Nafabelltan) in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-11-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Time to clinical improvement
timeFrame: up to 28 days
Secondary outcomes:
measure: Time to recovery
timeFrame: up to 28 days
measure: 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
timeFrame: Day 4, 7, 11, 14 and 28
measure: Proportion of patients with recovery as defined as the subject satisfies one of the following
timeFrame: Day 4, 7, 11, 14 and 28
measure: Change of clinical status assessed by 7-category ordinal scale
timeFrame: Day 4, 7, 11, 14 and 28
measure: Change in National Early Warning Score (NEWS)
timeFrame: Day 4, 7, 11, 14 and 28
measure: Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
timeFrame: up to 28 days
measure: Changes on CT scan/X-ray
timeFrame: Day 5, 11, 14 and 28
measure: Change from baseline of CRP
timeFrame: Day 4, 7, 11, 14 and 28
measure: Time to normalize the CRP
timeFrame: up to 28 days
measure: Duration of hospitalization
timeFrame: up to 28 days
measure: Duration of non-invasive ventilation or high flow oxygen use
timeFrame: up to 28 days
measure: Incidence of non-invasive ventilation or high flow oxygen use
timeFrame: up to 28 days
measure: Duration of supplement oxygen use
timeFrame: up to 28 days
measure: Incidence of supplement oxygen use
timeFrame: up to 28 days
measure: Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
timeFrame: up to 28 days
measure: Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
timeFrame: up to 28 days
measure: 28-Day mortality
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: A108_02CVD2014 Site# 9
city: Krasnoyarsk
country: Russian Federation
facility: A108_02CVD2014 Site# 26
city: Moscow
country: Russian Federation
facility: A108_02CVD2014 Site# 5
city: Moscow
country: Russian Federation
facility: A108_02CVD2014 Site# 8
city: Ryazan
country: Russian Federation
facility: A108_02CVD2014 Site# 31
city: St. Petersburg
country: Russian Federation
facility: A108_02CVD2014 Site# 25
city: St. Petersburg
country: Russian Federation
facility: A108_02CVD2014 Site# 29
city: St. Petersburg
country: Russian Federation
facility: A108_02CVD2014 Site# 30
city: St. Petersburg
country: Russian Federation
facility: A108_02CVD2014 Site# 3
city: St. Petersburg
country: Russian Federation
facility: A108_02CVD2014 Site# 4
city: Ufa
country: Russian Federation
facility: A108_02CVD2014 site#1
Study officials:
References:
citation: Zhuravel SV, Khmelnitskiy OK, Burlaka OO, Gritsan AI, Goloshchekin BM, Kim S, Hong KY. Nafamostat in hospitalized patients with moderate to severe COVID-19 pneumonia: a randomised Phase II clinical trial. EClinicalMedicine. 2021 Nov;41:101169. doi: 10.1016/j.eclinm.2021.101169. Epub 2021 Oct 27.