Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo

June 13, 2022 updated by: Daewoong Pharmaceutical Co. LTD.

A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19

To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

432

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults over the age of 19 as of the signed date in written consent
  • Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points)
  • Subjects who have symptoms within 7 days or 72 hours after diagnosis

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 52 weeks 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Part 1
- DWJ1248 600mg PO (100mg 2 tab, TID)
Other: Part 2
- DWJ1248 600mg PO (200mg 1 tab, TID)
Experimental: DWJ1248
Camostat mesylate
Other: Part 1
- DWJ1248 600mg PO (100mg 2 tab, TID)
Other: Part 2
- DWJ1248 600mg PO (200mg 1 tab, TID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Part 1) Time to SARS-CoV-2 eradication
Time Frame: Up to 28 days
Time to reach undetectable SARS-CoV-2 RNA level
Up to 28 days
(Part 2) Time to clinical improvement of subjective symptoms
Time Frame: Up to 14 days
Clinical improvement of subjective symptoms (days)
Up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Part 1) Rate of SARS-CoV-2 eradication
Time Frame: Days 4, 7, 10, and 14
Percent of patients with undetectable SARS-CoV-2 RNA level
Days 4, 7, 10, and 14
(Part 1/2) Time to clinical improvement of subjective symptoms
Time Frame: Up to 28 days
Up to 28 days
(Part 2) Change from baseline of subjective symptom scores
Time Frame: Days 4, 7, 10, 14, 21 and 28
Days 4, 7, 10, 14, 21 and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2020

Primary Completion (Actual)

September 14, 2021

Study Completion (Actual)

March 18, 2022

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_DWJ1248201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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