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

Phase 3

Terminated

• Conditions: SARS-COV-2 Infection; Covid19
• Interventions: Drug: Placebo; Drug: DWJ1248

• Registration Number: NCT04721535
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-06-07
• Primary Completion: 2021-09-23
• Study Completion: 2021-10-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-04
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
DWJ1248	DWJ1248	Camostat mesilate 200mg

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with COVID-19	Up to 14 days	positive result in RT-PCR test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of