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

Primary Purpose

Mild to Moderate COVID-19

Status

Terminated

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Part 1

Part 2

About this trial

This is an interventional treatment trial for Mild to Moderate COVID-19

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DWJ1248

Placebo

Arm Description

Camostat mesylate

Placebo

Outcomes

Primary Outcome Measures

(Part 1) Time to SARS-CoV-2 eradication

Time to reach undetectable SARS-CoV-2 RNA level

(Part 2) Time to clinical improvement of subjective symptoms

Clinical improvement of subjective symptoms (days)

Secondary Outcome Measures

(Part 1) Rate of SARS-CoV-2 eradication

Percent of patients with undetectable SARS-CoV-2 RNA level

(Part 1/2) Time to clinical improvement of subjective symptoms

(Part 2) Change from baseline of subjective symptom scores

Full Information

NCT ID

NCT04521296

First Posted

July 7, 2020

Last Updated

June 13, 2022

Sponsor

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT04521296

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Changes in drug development plans

Study Start Date

September 11, 2020 (Actual)

Primary Completion Date

September 14, 2021 (Actual)

Study Completion Date

March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild to Moderate COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

432 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DWJ1248

Arm Type

Experimental

Arm Description

Camostat mesylate

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Other

Intervention Name(s)

Part 1

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Part 2

Intervention Description

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

Primary Outcome Measure Information:

Title

(Part 1) Time to SARS-CoV-2 eradication

Description

Time to reach undetectable SARS-CoV-2 RNA level

Time Frame

Up to 28 days

Title

(Part 2) Time to clinical improvement of subjective symptoms

Description

Clinical improvement of subjective symptoms (days)

Time Frame

Up to 14 days

Secondary Outcome Measure Information:

Title

(Part 1) Rate of SARS-CoV-2 eradication

Description

Percent of patients with undetectable SARS-CoV-2 RNA level

Time Frame

Days 4, 7, 10, and 14

Title

(Part 1/2) Time to clinical improvement of subjective symptoms

Time Frame

Up to 28 days

Title

(Part 2) Change from baseline of subjective symptom scores

Time Frame

Days 4, 7, 10, 14, 21 and 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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