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

Phase 3

Terminated

• Conditions: Severe COVID-19
• Interventions: Drug: DWJ1248 with Remdesivir; Drug: Placebo with Remdesivir

• Registration Number: NCT04713176
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-19
• Study Start: 2021-02-02
• Primary Completion: 2022-05-02
• Study Completion: 2022-12-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWJ1248 with Remdesivir	DWJ1248 with Remdesivir	Camostat mesylate 200 mg, Remdesivir
Placebo with Remdesivir	Placebo with Remdesivir	Placebo, Remdesivir

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Desirable of Outcome Ranking (DOOR)	Day 15,29	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
Duration of Hospitalization	Day 29	The duration of hospitalization (days)
Time to death	Day 15,29	The percent of participants
Time to recovery	Day 3,5,8,11,15,22,29

Trial Locations

Locations (1)

National Medical Center; 🇰🇷 Seoul, Korea, Republic of