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

NCT04521296 | Terminated Phase 2

• 1 other identifier: DW_DWJ1248201
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (2)

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

  Time to reach undetectable SARS-CoV-2 RNA level

  Up to 28 days

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

  Clinical improvement of subjective symptoms (days)

  Up to 14 days

Secondary Outcomes (3)

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

  Days 4, 7, 10, and 14

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

  Up to 28 days

• (Part 2) Change from baseline of subjective symptom scores

  Days 4, 7, 10, 14, 21 and 28

Study Arms (2)

DWJ1248

EXPERIMENTAL

Camostat mesylate

Other: Part 1; Other: Part 2

Placebo

PLACEBO COMPARATOR

Placebo

Other: Part 1; Other: Part 2

Interventions

Part 1 OTHER

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

DWJ1248; Placebo

Part 2 OTHER

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

DWJ1248; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• Kim YS, Jeon SH, Kim J, Koh JH, Ra SW, Kim JW, Kim Y, Kim CK, Shin YC, Kang BD, Kang SJ, Park CH, Lee B, Lee JY, Lee CH, Choi JP, Kim JY, Yu SN, Peck KR, Kim SH, Heo JY, Kim HA, Park HJ, Choi J, Han J, Kim J, Kim HJ, Han SH, Yoon A, Park M, Park S, Kim Y, Jung M, Oh MD. A Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study To Evaluate the Efficacy and Safety of Camostat Mesylate (DWJ1248) in Adult Patients with Mild to Moderate COVID-19. Antimicrob Agents Chemother. 2023 Jan 24;67(1):e0045222. doi: 10.1128/aac.00452-22. Epub 2022 Dec 14.

  PMID: 36515544 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 20, 2020
• Study Start: September 11, 2020
• Primary Completion: September 14, 2021
• Study Completion: March 18, 2022
• Last Updated: June 15, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)