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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nafamostat Mesilate | Drug | Administered intravenously as a continuous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A108_02CVD2014 Site# 9 | Barnaul | Russia | ||||
| A108_02CVD2014 Site# 26 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34723164 | Derived | 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. |
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| 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 | Day 4, 7, 11, 14 and 28 |
| Proportion of patients with recovery as defined as 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 | Day 4, 7, 11, 14 and 28 |
| Change of clinical status assessed by 7-category ordinal scale | Day 4, 7, 11, 14 and 28 |
| Change in National Early Warning Score (NEWS) | Day 4, 7, 11, 14 and 28 |
| Time to National Early Warning Score (NEWS) of ≤ 2 which is maintained for 24 hours | 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 | Day 5, 11, 14 and 28 |
| Change from baseline of CRP | Day 4, 7, 11, 14 and 28 |
| Time to normalize the CRP | Decrease to the level of <10 mg/l | up to 28 days |
| Duration of hospitalization | up to 28 days |
| Duration of non-invasive ventilation or high flow oxygen use | 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 | up to 28 days |
| Duration of supplement oxygen use | up to 28 days |
| Incidence of supplement oxygen use | Proportion of patients of supplement oxygen use | up to 28 days |
| Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use | 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 | up to 28 days |
| 28-Day mortality | up to 28 days |
| Krasnoyarsk |
| Russia |
| A108_02CVD2014 Site# 5 | Moscow | Russia |
| A108_02CVD2014 Site# 8 | Moscow | Russia |
| A108_02CVD2014 Site# 31 | Ryazan | Russia |
| A108_02CVD2014 Site# 25 | Saint Petersburg | Russia |
| A108_02CVD2014 Site# 29 | Saint Petersburg | Russia |
| A108_02CVD2014 Site# 30 | Saint Petersburg | Russia |
| A108_02CVD2014 Site# 3 | Saint Petersburg | Russia |
| A108_02CVD2014 Site# 4 | Saint Petersburg | Russia |
| A108_02CVD2014 site#1 | Ufa | Russia |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C032855 | nafamostat |
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