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Completed

NCT Number: NCT04623021

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

A108_02CVD2014 Site# 9, Barnaul, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nafamostat Mesilate

Drug

Administered intravenously as a continuous infusion

Primary outcomes

  1. Time to clinical improvement

    Time frame: up to 28 days

    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

Secondary outcomes

  1. Time to recovery

    Time frame: up to 28 days

    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

  2. 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

    Time frame: Day 4, 7, 11, 14 and 28

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

    Time frame: Day 4, 7, 11, 14 and 28

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

    Time frame: Day 4, 7, 11, 14 and 28

  5. Change in National Early Warning Score (NEWS)

    Time frame: Day 4, 7, 11, 14 and 28

  6. Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours

    Time frame: up to 28 days

  7. Changes on CT scan/X-ray

    Time frame: Day 5, 11, 14 and 28

    Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray

  8. Change from baseline of CRP

    Time frame: Day 4, 7, 11, 14 and 28

  9. Time to normalize the CRP

    Time frame: up to 28 days

    Decrease to the level of <10 mg/l

  10. Duration of hospitalization

    Time frame: up to 28 days

  11. Duration of non-invasive ventilation or high flow oxygen use

    Time frame: up to 28 days

  12. Incidence of non-invasive ventilation or high flow oxygen use

    Time frame: up to 28 days

    Proportion of patients of non-invasive ventilation or high flow oxygen use

  13. Duration of supplement oxygen use

    Time frame: up to 28 days

  14. Incidence of supplement oxygen use

    Time frame: up to 28 days

    Proportion of patients of supplement oxygen use

  15. Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use

    Time frame: up to 28 days

  16. Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use

    Time frame: up to 28 days

    Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use

  17. 28-Day mortality

    Time frame: up to 28 days

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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