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

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04721535
• Collaborator: (none)
• Enrollment: 1,012
• Arms: 2
• Anticipated Duration (Months): 5.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; SARS-COV-2 Infection	Drug: DWJ1248; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1012 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized Double-blinded Controlled Clinical Trial of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
• Anticipated Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of subjects with COVID-19 [Up to 14 days]

   positive result in RT-PCR test

Secondary Outcome Measures

1. Percentage of subjects with hospitalization [Days 3, 7, 14, and 28]

   hospitalization due to COVID-19

2. Percentage of subjects who experience intensive care unit (ICU) [Days 3, 7, 14, and 28]

   ICU requirement due to COVID-19

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT04721535
• Other Study ID Numbers: DW_DWJ1248303
• First Posted: Jan 22, 2021
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19

Study Results

No Results Posted as of Feb 1, 2021