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A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

Primary Purpose

Covid19, SARS-COV-2 Infection

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1248
Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults over the age of 19 as of the signed date in written consent
  • Subjects in self-quarantine who contact from COVID-19 confirmed patient
  • Subjects who have COVID-19 negative RT-PCR result
  • Subjects with no symptoms of COVID-19

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 12 months 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

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DWJ1248

Placebo

Arm Description

Camostat mesilate 200mg

Placebo

Outcomes

Primary Outcome Measures

Percentage of subjects with COVID-19
positive result in RT-PCR test

Secondary Outcome Measures

Percentage of subjects with hospitalization
hospitalization due to COVID-19
Percentage of subjects who experience intensive care unit (ICU)
ICU requirement due to COVID-19

Full Information

First Posted
January 20, 2021
Last Updated
December 4, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT04721535
Brief Title
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Official Title
A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Termination of study due to sponsor's internal decision
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
October 6, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the prevention of SARS-COV-2 infection after administration of DWJ1248 in person who contact from COVID-19 confirmed patient compared to the placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-COV-2 Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DWJ1248
Arm Type
Experimental
Arm Description
Camostat mesilate 200mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
DWJ1248
Intervention Description
Orally, 1 tablet of DWJ1248 TID, up to 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Orally, 1 tablet of placebo TID, up to 14 days
Primary Outcome Measure Information:
Title
Percentage of subjects with COVID-19
Description
positive result in RT-PCR test
Time Frame
Up to 14 days
Secondary Outcome Measure Information:
Title
Percentage of subjects with hospitalization
Description
hospitalization due to COVID-19
Time Frame
Days 3, 7, 14, and 28
Title
Percentage of subjects who experience intensive care unit (ICU)
Description
ICU requirement due to COVID-19
Time Frame
Days 3, 7, 14, and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults over the age of 19 as of the signed date in written consent Subjects in self-quarantine who contact from COVID-19 confirmed patient Subjects who have COVID-19 negative RT-PCR result Subjects with no symptoms of COVID-19 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 12 months 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
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

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