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

Study Overview
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Brief Summary
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Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients

Official Title
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A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients

Conditions
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Severe COVID-19

Intervention / Treatment
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* Drug: DWJ1248 with Remdesivir
* Drug: Placebo with Remdesivir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWJ1248 with Remdesivir<br>Camostat mesylate 200 mg, Remdesivir | Drug: DWJ1248 with Remdesivir<br>* 1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV<br>|
| Placebo Comparator: Placebo with Remdesivir<br>Placebo, Remdesivir | Drug: Placebo with Remdesivir<br>* 1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Up to 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery |  | 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 | Day 15,29 | 
| Duration of Hospitalization | The duration of hospitalization (days) | Day 29 | 
| Time to death | The percent of participants | Day 15,29 |