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

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ClinicalTrials.gov Identifier: NCT04628143
Recruitment Status : Not yet recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Nafamostat Mesilate Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : November 20, 2020
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
No Intervention: Standard of Care
Standard of Care Treatment for COVID-19 Infection
Experimental: Nafamostat + Standard of Care
Nafamostat mesylate on top of standard of care
Drug: Nafamostat Mesilate
Administered intravenously as a continuous infusion
Other Name: CKD-314




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
  3. Proportion of patients with recovery as defined as the subject satisfies one of the following [ Time Frame: Day 4, 7, 10, 14, 21 and 28 ]
    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

  4. Change of clinical status assessed by 7-category ordinal scale [ Time Frame: Day 4, 7, 10, 14, 21 and 28 ]
  5. Change in National Early Warning Score (NEWS) [ Time Frame: Day 4, 7, 10, 14, 21 and 28 ]
  6. Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained [ Time Frame: up to 28 days ]
  7. Duration of hospitalization [ Time Frame: up to 28 days ]
    Measured in days.

  8. Duration of non-invasive ventilation or high flow oxygen use [ Time Frame: up to 28 days ]
  9. 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

  10. Duration of supplement oxygen use [ Time Frame: up to 28 days ]
  11. Incidence of supplement oxygen use [ Time Frame: up to 28 days ]
    Proportion of patients of supplement oxygen use

  12. Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use [ Time Frame: up to 28 days ]
  13. 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

  14. 28-Day mortality [ Time Frame: up to 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628143


Contacts
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Contact: Dongho Kim, MD 82-2-970-1298 kdh281920@gmail.com

Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Dongho Kim, MD Korea Cancer Center Hospital
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04628143    
Other Study ID Numbers: A108_01CVD2013
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chong Kun Dang Pharmaceutical:
COVID-19
Additional relevant MeSH terms:
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Nafamostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anticoagulants
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors