NCT04721535

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

June 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2021

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

January 20, 2021

Last Update Submit

December 4, 2022

Conditions

Covid19SARS-COV-2 Infection

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects with COVID-19

    positive result in RT-PCR test

    Up to 14 days

Secondary Outcomes (2)

  • Percentage of subjects with hospitalization

    Days 3, 7, 14, and 28

  • Percentage of subjects who experience intensive care unit (ICU)

    Days 3, 7, 14, and 28

Study Arms (2)

DWJ1248

EXPERIMENTAL

Camostat mesilate 200mg

Drug: DWJ1248

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DWJ1248DRUG

Orally, 1 tablet of DWJ1248 TID, up to 14 days

DWJ1248
PlaceboDRUG

Orally, 1 tablet of placebo TID, up to 14 days

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

June 7, 2021

Primary Completion

September 23, 2021

Study Completion

October 6, 2021

Last Updated

December 7, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)