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

Daewoong Pharmaceutical

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Mild to Moderate COVID-19

Treatments: Other: Part 2; Other: Part 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04521296

DW_DWJ1248201

Details and patient eligibility

About

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

Enrollment: 432 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 2 patient groups, including a placebo group

DWJ1248

Experimental group

Description:

Camostat mesylate

Treatment:

Other: Part 1

Other: Part 2

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Part 1

Other: Part 2