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

Severe COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04713176
• Other study ID #: DW_DWJ1248302
• Status: Terminated
• Phase: Phase 3
• Start date: February 2, 2021
• Est. completion date: December 9, 2022

Study information

• Verified date: September 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: December 9, 2022
• Est. primary completion date: May 2, 2022
• 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 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

Related Conditions & MeSH terms

• COVID-19
• Severe COVID-19

Intervention

Drug:
• DWJ1248 with Remdesivir
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
• Placebo with Remdesivir
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV

Locations

Country	Name	City	State
Korea, Republic of	National Medical Center	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	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	Time to recovery		Day 3,5,8,11,15,22,29
Secondary	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
Secondary	Duration of Hospitalization	The duration of hospitalization (days)	Day 29
Secondary	Time to death	The percent of participants	Day 15,29