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

NCT04623021 | Completed Phase 2

• 1 other identifier: A108_02CVD2014
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 11

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

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 (17)

• 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, 11, 14 and 28

• Proportion of patients with recovery as defined as the subject satisfies one of the following

  Day 4, 7, 11, 14 and 28

• Change of clinical status assessed by 7-category ordinal scale

  Day 4, 7, 11, 14 and 28

• Change in National Early Warning Score (NEWS)

  Day 4, 7, 11, 14 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

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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (11)

A108_02CVD2014 Site# 9

Barnaul, Russia

Location

A108_02CVD2014 Site# 26

Krasnoyarsk, Russia

Location

A108_02CVD2014 Site# 5

Moscow, Russia

Location

A108_02CVD2014 Site# 8

Moscow, Russia

Location

A108_02CVD2014 Site# 31

Ryazan, Russia

Location

A108_02CVD2014 Site# 25

Saint Petersburg, Russia

Location

A108_02CVD2014 Site# 29

Saint Petersburg, Russia

Location

A108_02CVD2014 Site# 30

Saint Petersburg, Russia

Location

A108_02CVD2014 Site# 3

Saint Petersburg, Russia

Location

A108_02CVD2014 Site# 4

Saint Petersburg, Russia

Location

A108_02CVD2014 site#1

Ufa, Russia

Location

Related Publications (1)

• 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.

  PMID: 34723164 DERIVED

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 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 5, 2020
• First Posted: November 10, 2020
• Study Start: September 25, 2020
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (11)