Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: CKD-314: CKD-314 is administered intravenously and standard of care is also performed.
Dosage form: Injection 50 mg/vial.
Administration route: Intravenous (IV) infusion. Frequency and
Sponsors
Chong Kun Dang Pharmaceutical Corp
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients aged greater than or equal to 18 years 2) Patients diagnosed with COVID-19 infection and pneumonia 3) Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.
Exclusion criteria
Exclusion criteria: 1) Patients with history of hypersensitivity to the study drug 2) Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study 3) Patients who are deemed to ineligible to participate in the study for other reasons by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recoveryTimepoint: Time Frame: From day1 to day 28. Day of recovery is defined as the first day on which the subject meets the criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to clinical improvementTimepoint: Time Frame: From day1 to day 28. as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status. | — |
Countries
Argentina, Brazil, India, Peru, Republic of Korea, Russian Federation, Thailand, Ukraine
Contacts
Public ContactAdarsh Verma
Syneos Health
Outcome results
None listed