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

Mild to Moderate COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04521296
• Other study ID #: DW_DWJ1248201
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 11, 2020
• Est. completion date: March 18, 2022

Study information

• Verified date: October 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 432
• Est. completion date: March 18, 2022
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Mild to Moderate COVID-19

Intervention

Other:
• Part 1
- DWJ1248 600mg PO (100mg 2 tab, TID)
• Part 2
- DWJ1248 600mg PO (200mg 1 tab, TID)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Part 1) Time to SARS-CoV-2 eradication	Time to reach undetectable SARS-CoV-2 RNA level	Up to 28 days
Primary	(Part 2) Time to clinical improvement of subjective symptoms	Clinical improvement of subjective symptoms (days)	Up to 14 days
Secondary	(Part 1) Rate of SARS-CoV-2 eradication	Percent of patients with undetectable SARS-CoV-2 RNA level	Days 4, 7, 10, and 14
Secondary	(Part 1/2) Time to clinical improvement of subjective symptoms		Up to 28 days
Secondary	(Part 2) Change from baseline of subjective symptom scores		Days 4, 7, 10, 14, 21 and 28