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

Daewoong Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Severe COVID-19

Treatments: Drug: DWJ1248 with Remdesivir; Drug: Placebo with Remdesivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT04713176

DW_DWJ1248302

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

DWJ1248 with Remdesivir

Experimental group

Description:

Camostat mesylate 200 mg, Remdesivir

Treatment:

Drug: DWJ1248 with Remdesivir

Placebo with Remdesivir

Placebo Comparator group

Description:

Placebo, Remdesivir

Treatment:

Drug: Placebo with Remdesivir