Official Title
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19
Brief Summary

To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.

Status
Terminated
Conditions
Mild to Moderate COVID-19
Interventions

Other: Part 1

- DWJ1248 600mg PO (100mg 2 tab, TID)

Other: Part 2

- DWJ1248 600mg PO (200mg 1 tab, TID)

Eligibility Criteria

Inclusion Criteria:

- Adults over the age of 19 as of the signed date in written consent

- Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS
is 0-6 or if one item is 3 points)

- Subjects who have symptoms within 7 days or 72 hours after diagnosis

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 52 weeks 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

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

Seoul National University Hospital
Seoul, Korea, Republic of

Sponsors / Collaborators
Daewoong Pharmaceutical Co. LTD.
NCT Number
NCT04521296
MeSH Terms
COVID-19