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TerminatedNCT04521296Updated Jun 15, 2022

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

A Phase 2/3 interventional study of Part 1 and Part 2 in Mild to Moderate COVID-19, sponsored by Daewoong Pharmaceutical Co. LTD.. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 2/3, Interventional, and Treatment

Why this study was terminated
Changes in drug development plans
Phase
Phase 2/3
Study type
Interventional
Enrollment
432
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Mild to Moderate COVID-19

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03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 432 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

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.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
432 participants (actual)

Study arms

  • Experimental
    DWJ1248

    Camostat mesylate

    Other: Part 1 · Other: Part 2

  • Placebo comparator
    Placebo

    Placebo

    Other: Part 1 · Other: Part 2

Interventions

  • OtherPart 1

    - DWJ1248 600mg PO (100mg 2 tab, TID)

  • OtherPart 2

    - DWJ1248 600mg PO (200mg 1 tab, TID)

06

What researchers measure

Primary outcomes

  1. (Part 1) Time to SARS-CoV-2 eradication

    Time to reach undetectable SARS-CoV-2 RNA level

    Time frame: Up to 28 days

  2. (Part 2) Time to clinical improvement of subjective symptoms

    Clinical improvement of subjective symptoms (days)

    Time frame: Up to 14 days

Secondary outcomes

  1. (Part 1) Rate of SARS-CoV-2 eradication

    Percent of patients with undetectable SARS-CoV-2 RNA level

    Time frame: Days 4, 7, 10, and 14

  2. (Part 1/2) Time to clinical improvement of subjective symptoms

    Time frame: Up to 28 days

  3. (Part 2) Change from baseline of subjective symptom scores

    Time frame: Days 4, 7, 10, 14, 21 and 28

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04521296
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Aug 20, 2020
Start date
Sep 11, 2020
Primary completion
Sep 14, 2021
Completion
Mar 18, 2022
Last update
Jun 15, 2022

Oversight

Data monitoring committee
No
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 Oct 2021. You cannot join it, but the record below documents what was studied.

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