Back to resultsEfficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
Primary Purpose
Severe COVID-19
Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1248 with Remdesivir
Placebo with Remdesivir
Sponsored by
About this trial
This is an interventional treatment trial for Severe COVID-19
Eligibility Criteria
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
Sites / Locations
- National Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DWJ1248 with Remdesivir
Placebo with Remdesivir
Arm Description
Camostat mesylate 200 mg, Remdesivir
Placebo, Remdesivir
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Time to recovery
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
Duration of Hospitalization
The duration of hospitalization (days)
Time to death
The percent of participants
Full Information
NCT ID
NCT04713176
First Posted
January 14, 2021
Last Updated
September 27, 2023
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT04713176
Brief Title
Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Termination of study due to sponsor's internal decision
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWJ1248 with Remdesivir
Arm Type
Experimental
Arm Description
Camostat mesylate 200 mg, Remdesivir
Arm Title
Placebo with Remdesivir
Arm Type
Placebo Comparator
Arm Description
Placebo, Remdesivir
Intervention Type
Drug
Intervention Name(s)
DWJ1248 with Remdesivir
Intervention Description
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Intervention Type
Drug
Intervention Name(s)
Placebo with Remdesivir
Intervention Description
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Primary Outcome Measure Information:
Title
Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days
Description
Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)
Time Frame
Up to 29 days
Secondary Outcome Measure Information:
Title
Time to recovery
Time Frame
Day 3,5,8,11,15,22,29
Title
Desirable of Outcome Ranking (DOOR)
Description
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
Time Frame
Day 15,29
Title
Duration of Hospitalization
Description
The duration of hospitalization (days)
Time Frame
Day 29
Title
Time to death
Description
The percent of participants
Time Frame
Day 15,29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Medical Center
City
Seoul
ZIP/Postal Code
04564
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
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