Study Stopped
Termination of study due to sponsor's internal decision
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
1 other identifier
interventional
240
1 country
1
Brief Summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2022
CompletedSeptember 29, 2023
September 1, 2023
1.2 years
January 14, 2021
September 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Time to recovery
Day 3,5,8,11,15,22,29
Desirable of Outcome Ranking (DOOR)
Day 15,29
Duration of Hospitalization
Day 29
Time to death
Day 15,29
Study Arms (2)
DWJ1248 with Remdesivir
EXPERIMENTALCamostat mesylate 200 mg, Remdesivir
Placebo with Remdesivir
PLACEBO COMPARATORPlacebo, Remdesivir
Interventions
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Medical Center
Seoul, 04564, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 19, 2021
Study Start
February 2, 2021
Primary Completion
May 2, 2022
Study Completion
December 9, 2022
Last Updated
September 29, 2023
Record last verified: 2023-09