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Completed

NCT Number: NCT04628143

A Study Evaluating the Efficacy and Safety of CKD-314 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

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea Cancer Center Hospital

Seoul, South Korea

About this study

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

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:
  • 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, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids,

③ 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

Treatment and study plan

Nafamostat Mesilate

Drug

Administered intravenously as a continuous infusion

Other names: CKD-314

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, 10, 14, 21 and 28

    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

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Aug 13, 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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