Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
NCT ID: NCT04713176
Last Updated: 2023-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
240 participants
INTERVENTIONAL
2021-02-02
2022-12-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo
NCT04521296
A Study of DWJ1248 in Prevention of COVID-19 Infection After the Exposure of SARS-COV-2
NCT04721535
Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
NCT05226533
A Trial of Remdesivir in Adults With Severe COVID-19
NCT04257656
Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
NCT04501952
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DWJ1248 with Remdesivir
Camostat mesylate 200 mg, Remdesivir
DWJ1248 with Remdesivir
1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Placebo with Remdesivir
Placebo, Remdesivir
Placebo with Remdesivir
1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DW_DWJ1248302
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.