COVID-19Phase 2NCT04623021
A Study Evaluating the Efficacy and Safety of CKD-314 (Nafabelltan) 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 11 sites in Russia.
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
- 104 participants
- Where
- 11 sitesRussia
- Study dates
- 25 Sep 2020to 12 Dec 2020
- 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:
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
A108_02CVD2014 Site# 9
Barnaul
A108_02CVD2014 Site# 26
Krasnoyarsk
A108_02CVD2014 Site# 5
Moscow
A108_02CVD2014 Site# 8
Moscow
A108_02CVD2014 Site# 31
Ryazan
A108_02CVD2014 Site# 25
Saint Petersburg
A108_02CVD2014 Site# 29
Saint Petersburg
A108_02CVD2014 Site# 30
Saint Petersburg
A108_02CVD2014 Site# 3
Saint Petersburg
A108_02CVD2014 Site# 4
Saint Petersburg
A108_02CVD2014 site#1
Ufa
About this study
Official 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
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
- Conditions
- COVID-19
- Being tested
- Nafamostat Mesilate
- 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
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 (17)
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
Measured: Day 4, 7, 11, 14 and 28
Proportion of patients with recovery as defined as the subject satisfies one of the following
- 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: Day 4, 7, 11, 14 and 28
Change of clinical status assessed by 7-category ordinal scale
Measured: Day 4, 7, 11, 14 and 28
Change in National Early Warning Score (NEWS)
Measured: Day 4, 7, 11, 14 and 28
Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
Measured: up to 28 days
Changes on CT scan/X-ray
Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray
Measured: Day 5, 11, 14 and 28
Change from baseline of CRP
Measured: Day 4, 7, 11, 14 and 28
Time to normalize the CRP
Decrease to the level of <10 mg/l
Measured: up to 28 days
Duration of hospitalization
Measured: up to 28 days
Duration of non-invasive ventilation or high flow oxygen use
Measured: up to 28 days
Incidence of non-invasive ventilation or high flow oxygen use
Proportion of patients of non-invasive ventilation or high flow oxygen use
Measured: up to 28 days
Duration of supplement oxygen use
Measured: up to 28 days
Incidence of supplement oxygen use
Proportion of patients of supplement oxygen use
Measured: up to 28 days
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Measured: up to 28 days
Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Measured: up to 28 days
28-Day mortality
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start25 Sep 2020
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623021
- Sponsor's protocol ID
- A108_02CVD2014
- Status last verified
- Jan 2021
- First submitted
- 5 Nov 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhuravel SV, Khmelnitskiy OK, Burlaka OO, Gritsan AI, Goloshchekin BM, Kim S, Hong KY. Nafamostat in hospitalized patients with moderate to severe COVID-19 pneumonia: a randomised Phase II clinical trial. EClinicalMedicine. 2021 Nov;41:101169. doi: 10.1016/j.eclinm.2021.101169. Epub 2021 Oct 27.
PubMed 34723164
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04623021
- Acronym / sponsor ID
- A108_02CVD2014
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 10 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
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 (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 MesilateAdministered 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
17 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, 11, 14 and 28
Proportion of patients with recovery as defined as the subject satisfies one of the following
Time frame: Day 4, 7, 11, 14 and 28
Change of clinical status assessed by 7-category ordinal scale
Time frame: Day 4, 7, 11, 14 and 28
Change in National Early Warning Score (NEWS)
Time frame: Day 4, 7, 11, 14 and 28
Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours
Time frame: up to 28 days
Changes on CT scan/X-ray
Time frame: Day 5, 11, 14 and 28
Change from baseline of CRP
Time frame: Day 4, 7, 11, 14 and 28
Time to normalize the CRP
Time frame: up to 28 days
Duration of hospitalization
Time frame: up to 28 days
Duration of non-invasive ventilation or high flow oxygen use
Time frame: up to 28 days
Incidence of non-invasive ventilation or high flow oxygen use
Time frame: up to 28 days
Duration of supplement oxygen use
Time frame: up to 28 days
Incidence of supplement oxygen use
Time frame: up to 28 days
Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time frame: up to 28 days
Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time frame: up to 28 days
28-Day mortality
Time frame: up to 28 days
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 2 Feb 2021.
- Derived from this study: PubMed 34723164Zhuravel SV, Khmelnitskiy OK, Burlaka OO, Gritsan AI, Goloshchekin BM, Kim S, Hong KY. Nafamostat in hospitalized patients with moderate to severe COVID-19 pneumonia: a randomised Phase II clinical trial. EClinicalMedicine. 2021 Nov;41:101169. doi: 10.1016/j.eclinm.2021.101169. Epub 2021 Oct 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites 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 11 sites in Russia.
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 5 inclusion and 13 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. 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?
On the ClinicalTrials.gov record for NCT04623021, which also lists 1 linked publication.
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 2 Feb 2021.