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

Phase 3TerminatedNCT04713176

Daewoong Pharmaceutical Co. LTD.240 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Severe COVID-19

Interventions

DWJ1248 with RemdesivirDRUG

1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV

Placebo with RemdesivirDRUG

1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

National Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of Subjects with Point 7 or Point 8 in the 8 point ordinal scale during 29 days

Percentage of patients with death(ordinal scale of 8) or ECMO patients(ordinal scale of 7)

Time frame: Up to 29 days

Secondary Outcomes

Time to recovery

Time frame: Day 3,5,8,11,15,22,29

Desirable of Outcome Ranking (DOOR)

The DOOR is scored by evaluating two items: ordinal scale and serious adverse events. DOORs are as follows: 1: Recovery (corresponding to the ordinal scale of 1, 2, or 3); 2: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with no serious adverse events; 3: Improvement (reduced by more than 1 score of the ordinal scale compared to baseline) with serious adverse events; 4: No change (no change in the ordinal scale compared to baseline) with no serious adverse events; 5: No change (no change in the ordinal scale compared to baseline) with serious adverse event regardless of causality; 6: Deterioration (increased by more than 1 score of the ordinal scale compared to baseline); 7: Death

Time frame: Day 15,29

Duration of Hospitalization

The duration of hospitalization (days)

Time frame: Day 29

Time to death

The percent of participants

Time frame: Day 15,29

Data from ClinicalTrials.gov

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