TerminatedNCT04721535Updated Dec 7, 2022

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

A Phase 3 interventional study of DWJ1248 and Placebo in Covid19 and SARS-COV-2 Infection, sponsored by Daewoong Pharmaceutical Co. LTD.. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 3, Interventional, and Prevention

Why this study was terminated

Termination of study due to sponsor's internal decision

Phase: Phase 3
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study 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.

Conditions studied

Covid19
SARS-COV-2 Infection

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In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 9 is below the median of 120 across 4,201 interventional studies indexed under Infections.

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Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: 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

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

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 9 participants (actual)

Study arms

Experimental
DWJ1248
Camostat mesilate 200mg
Drug: DWJ1248
Placebo comparator
Placebo
Placebo
Drug: Placebo

Interventions

DrugDWJ1248
Orally, 1 tablet of DWJ1248 TID, up to 14 days
DrugPlacebo
Orally, 1 tablet of placebo TID, up to 14 days

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Samsung Medical Center
Seoul, Korea, Republic of

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04721535
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Responsible party: Sponsor
First posted: Jan 22, 2021
Start date: Jun 7, 2021
Primary completion: Sep 23, 2021
Completion: Oct 6, 2021
Last update: Dec 7, 2022

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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