COVID-19Phase 2NCT04628143
A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
A Phase 2 study testing Nafamostat Mesilate in people with COVID-19, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Nafamostat Mesilate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2020to 5 Apr 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- COVID-19
- Being tested
- Nafamostat Mesilate
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nafamostat MesilateDrug
Also called CKD-314
Administered intravenously as a continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nafamostat Mesilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 28 days
Secondary outcomes (2)
Time to recovery
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
Measured: 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
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
Measured: Day 4, 7, 10, 14, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start21 Dec 2020
- Primary completion5 Apr 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongho Kim, MD, Principal investigator, Korea Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628143
- Sponsor's protocol ID
- A108_01CVD2013
- Status last verified
- Apr 2021
- First submitted
- 10 Nov 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04628143
- Acronym / sponsor ID
- A108_01CVD2013
- Conditions
- COVID-19
- Keywords
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 5 Apr 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care Treatment for COVID-19 Infection |
| Nafamostat + Standard of Care | Experimental | Drug: Nafamostat MesilateNafamostat mesylate on top of standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women Aged ≥18 years
- Hospitalized subjects who have confirmed COVID-19 infection and have evidence of pneumonia:
- 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
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nafamostat MesilateAlso: CKD-314Administered intravenously as a continuous infusion | Drug | Nafamostat + Standard of Care |
Primary outcome
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
2 secondary outcomes
Time to recovery
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongho Kim, MD principal investigator
Korea Cancer Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nafamostat Mesilate in people with COVID-19, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.