Covid19, SARS-COV-2 Infection
Conditions
Brief summary
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.
Interventions
DRUGDWJ1248
Orally, 1 tablet of DWJ1248 TID, up to 14 days
DRUGPlacebo
Orally, 1 tablet of placebo TID, up to 14 days
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults over the age of 19 as of the signed date in written consent * Subjects in self-quarantine who contact from COVID-19 confirmed patient * Subjects who have COVID-19 negative RT-PCR result * Subjects with no symptoms of COVID-19
Exclusion criteria
* Subjects who cannot orally administer the investigational products * Subjects who need administration of immunosuppressants * Subjects who are allergic or sensitive to investigational products or its ingredients * Subjects who have a history of drug and/or alcohol abuse within 12 months before screening * Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with COVID-19 | Up to 14 days | positive result in RT-PCR test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with hospitalization | Days 3, 7, 14, and 28 | hospitalization due to COVID-19 |
| Percentage of subjects who experience intensive care unit (ICU) | Days 3, 7, 14, and 28 | ICU requirement due to COVID-19 |
Countries
South Korea
Outcome results
None listed