- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04628143
A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
August 9, 2021 updated by: Chong Kun Dang Pharmaceutical
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
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
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Korea Cancer Center Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
Administered intravenously as a continuous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
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Day 4, 7, 10, 14, 21 and 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dongho Kim, MD, Korea Cancer Center Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2020
Primary Completion (Actual)
April 5, 2021
Study Completion (Actual)
April 5, 2021
Study Registration Dates
First Submitted
November 10, 2020
First Submitted That Met QC Criteria
November 10, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
August 13, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Anticoagulants
- Trypsin Inhibitors
- Complement Inactivating Agents
- Nafamostat
Other Study ID Numbers
- A108_01CVD2013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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