Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients

• Status: Recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Remdesivir

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