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

NCT ID: NCT04721535

Last Updated: 2022-12-07

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

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 SARS-COV-2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWJ1248

Camostat mesilate 200mg

Group Type EXPERIMENTAL

DWJ1248

Intervention Type DRUG

Orally, 1 tablet of DWJ1248 TID, up to 14 days

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally, 1 tablet of placebo TID, up to 14 days

Interventions

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DWJ1248

Orally, 1 tablet of DWJ1248 TID, up to 14 days

Intervention Type DRUG

Placebo

Orally, 1 tablet of placebo TID, up to 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DW_DWJ1248303

Identifier Type: -

Identifier Source: org_study_id

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