Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
Phase 3
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/12/038691
- Lead Sponsor
- Chong Kun Dang Pharmaceutical Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 46
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to recoveryTimepoint: Time Frame: From day1 to day 28. <br/ ><br>Day of recovery is defined as the first day on which the subject meets the criteria
- Secondary Outcome Measures
Name Time Method Time to clinical improvementTimepoint: Time Frame: From day1 to day 28. <br/ ><br>as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status.