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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2022-03-18

Brief Summary

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

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Detailed Description

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Conditions

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Mild to Moderate COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWJ1248

Camostat mesylate

Group Type EXPERIMENTAL

Part 1

Intervention Type OTHER

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

Part 2

Intervention Type OTHER

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

Placebo

Group Type PLACEBO_COMPARATOR

Part 1

Intervention Type OTHER

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

Part 2

Intervention Type OTHER

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

Interventions

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Part 1

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

Intervention Type OTHER

Part 2

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No