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

A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; SARS-COV-2 Infection
• Intervention / Treatment: Drug: DWJ1248; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Orally, 1 tablet of placebo TID, up to 14 days
Experimental: DWJ1248; Camostat mesilate 200mg	Drug: DWJ1248; Orally, 1 tablet of DWJ1248 TID, up to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with COVID-19	positive result in RT-PCR test	Up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with hospitalization	hospitalization due to COVID-19	Days 3, 7, 14, and 28
Percentage of subjects who experience intensive care unit (ICU)	ICU requirement due to COVID-19	Days 3, 7, 14, and 28

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): October 6, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 4, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: DW_DWJ1248303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No