Clinical trial NCT04628143: A Study Evaluating the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19 Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Time to clinical improvement
timeFrame: up to 28 days
Secondary outcomes:
measure: Time to recovery
timeFrame: up to 28 days
measure: 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
timeFrame: Day 4, 7, 10, 14, 21 and 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
Study officials:
affiliation: Korea Cancer Center Hospital
name: Dongho Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: