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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04721535
• Other study ID #: DW_DWJ1248303
• Status: Terminated
• Phase: Phase 3
• Start date: June 7, 2021
• Est. completion date: October 6, 2021

Study information

• Verified date: December 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 6, 2021
• Est. primary completion date: September 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Covid19
• Infections
• SARS-COV-2 Infection

Intervention

Drug:
• DWJ1248
Orally, 1 tablet of DWJ1248 TID, up to 14 days
• Placebo
Orally, 1 tablet of placebo TID, up to 14 days

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with COVID-19	positive result in RT-PCR test	Up to 14 days
Secondary	Percentage of subjects with hospitalization	hospitalization due to COVID-19	Days 3, 7, 14, and 28
Secondary	Percentage of subjects who experience intensive care unit (ICU)	ICU requirement due to COVID-19	Days 3, 7, 14, and 28