COVID-19
Conditions
Keywords
COVID-19
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
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
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: * 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
Exclusion criteria
* 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\[However, ① steroids being used for the treatment of Corona 19 (eg, Dexamethasone, etc.), ② topical steroids, ③ Patients who are administering inhaled steroids are not eligible for exclusion\] * 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
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 |
|---|---|---|
| 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 |
| 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, 10, 14, 21 and 28 | 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 |
Countries
South Korea
Outcome results
None listed