COVID-19
Conditions
Brief 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
Interventions
Administered intravenously as a continuous infusion
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 4, 7, 11, 14 and 28 | 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 |
| 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 | Day 5, 11, 14 and 28 | Measured as proportion of patients with improved, not changed or worsened CT scan/X-ray |
| Change from baseline of CRP | Day 4, 7, 11, 14 and 28 | — |
| Time to normalize the CRP | up to 28 days | Decrease to the level of \<10 mg/l |
| Time to recovery | 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 |
| Duration of non-invasive ventilation or high flow oxygen use | up to 28 days | — |
| Incidence of non-invasive ventilation or high flow oxygen use | up to 28 days | Proportion of patients of non-invasive ventilation or high flow oxygen use |
| Duration of supplement oxygen use | up to 28 days | — |
| Incidence of supplement oxygen use | up to 28 days | Proportion of patients of supplement oxygen use |
| Duration of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use | up to 28 days | — |
| Incidence of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use | up to 28 days | Proportion of patients of invasive ventilation or extracorporeal membrane oxygenation (ECMO) use |
| 28-Day mortality | up to 28 days | — |
| Duration of hospitalization | up to 28 days | — |
Countries
Russia
Outcome results
None listed