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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Administered intravenously as a continuous infusion
A108_02CVD2014 Site# 9
Barnaul, Russia
A108_02CVD2014 Site# 26
Krasnoyarsk, Russia
A108_02CVD2014 Site# 5
Moscow, Russia
A108_02CVD2014 Site# 8
Moscow, Russia
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
Time frame: up to 28 days
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
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
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
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
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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
...and 1 more locations
Changes on CT scan/X-ray
Measured as proportion of patients with improved, not changed or worsened 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
Decrease to the level of \<10 mg/l
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
Proportion of patients 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
Proportion of patients 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
Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use
Time frame: up to 28 days
28-Day mortality
Time frame: up to 28 days