Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Drug: DWJ1248 with Remdesivir
PO, 1 tablet of DWJ1248 TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
Drug: Placebo with Remdesivir
PO, 1 tablet of placebo TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
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
National Medical Center
Seoul, Korea, Republic of
Investigator: Jae-Hyun Jeon
mdjjh@nmc.or.kr