Status:
TERMINATED
Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Severe COVID-19
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04713176
Start Date
February 2 2021
End Date
December 9 2022
Last Update
September 29 2023
Active Locations (1)
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1
National Medical Center
Seoul, South Korea, 04564