A Study of DWJ1248 in Prevention of COVID-19 Infection Af... | NCT04721535

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

NCT04721535

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Terminated

Last Update Posted

Dec 7, 2022Actual

Enrollment

9Actual

Phase

Phase 3

Conditions

Covid19
SARS-COV-2 Infection

Interventions

DWJ1248
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Termination of study due to sponsor's internal decision

Expanded Access Info

Start Date

Jun 7, 2021Actual

Primary Completion Date

Sep 23, 2021Actual

Completion Date

Oct 6, 2021Actual

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 20, 2021

First Posted Date

Jan 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2022

Last Update Posted Date

Dec 7, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWJ1248	Experimental	Camostat mesilate 200mg	Drug: DWJ1248
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWJ1248	Drug	Orally, 1 tablet of DWJ1248 TID, up to 14 days	DWJ1248

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided