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

Phase 2

Terminated

• Conditions: Mild to Moderate COVID-19

• Registration Number: NCT04521296
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Study Start: 2020-09-11
• Primary Completion: 2021-09-14
• Status Verified: 2021-10
• Study Completion: 2022-03-18
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 432

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
(Part 1) Time to SARS-CoV-2 eradication	Up to 28 days	Time to reach undetectable SARS-CoV-2 RNA level
(Part 2) Time to clinical improvement of subjective symptoms	Up to 14 days	Clinical improvement of subjective symptoms (days)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of