Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients

A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients

Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients

Study Overview

• Status: Terminated
• Conditions: Severe COVID-19
• Intervention / Treatment: Drug: DWJ1248 with Remdesivir; Drug: Placebo with Remdesivir

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04564
    • National medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults over the age of 19 as of the signed date in written consent
• Subjects with COVID-19 according to RT-PCR test(within 10 days)
• Subjects who need to be hospitalized and injected Remdesivir

Exclusion Criteria:

• Subjects who cannot orally administer the investigational products
• Subjects who requiring mechanical ventilation or ECMO
• Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
• Subjects who need administration of immunosuppressants
• Subjects who are allergic or sensitive to investigational products or its ingredients
• Crcl < 30 mL/min or eGFR < 30 mL/min/1.73m^2
• AST or ALT >= 5xULN
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWJ1248 with Remdesivir; Camostat mesylate 200 mg, Remdesivir	Drug: DWJ1248 with Remdesivir; 1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Placebo Comparator: Placebo with Remdesivir; Placebo, Remdesivir	Drug: Placebo with Remdesivir; 1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days	Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)	Up to 29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desirable of Outcome Ranking (DOOR)	The DOOR is scored by evaluating two items: ordinal scale and serious adverse events. DOORs are as follows: 1: Recovery (corresponding to the ordinal scale of 1, 2, or 3); 2: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with no serious adverse events; 3: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with serious adverse events; 4: No change (no change in the ordinal scale compared to baseline) with no serious adverse events; 5: No change (no change in the ordinal scale compared to baseline) with serious adverse event regardless of causality; 6: Deterioration (increased by more than 1 score of the ordinal scale compared to baseline); 7: Death	Day 15,29
Time to recovery		Day 3,5,8,11,15,22,29
Duration of Hospitalization	The duration of hospitalization (days)	Day 29
Time to death	The percent of participants	Day 15,29

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): December 9, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Remdesivir
• Other Study ID Numbers: DW_DWJ1248302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No