Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04521296

Enrollment

432

Registered

2020-08-20

Start date

2020-09-11

Completion date

2022-03-18

Last updated

2022-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

OTHERPart 1

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

OTHERPart 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
(Part 1) Time to SARS-CoV-2 eradication	Up to 28 days	Time to reach undetectable SARS-CoV-2 RNA level
(Part 2) Time to clinical improvement of subjective symptoms	Up to 14 days	Clinical improvement of subjective symptoms (days)

Secondary

Measure	Time frame	Description
(Part 1) Rate of SARS-CoV-2 eradication	Days 4, 7, 10, and 14	Percent of patients with undetectable SARS-CoV-2 RNA level
(Part 1/2) Time to clinical improvement of subjective symptoms	Up to 28 days	—
(Part 2) Change from baseline of subjective symptom scores	Days 4, 7, 10, 14, 21 and 28	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026