Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients
Study Details
Study Description
Brief Summary
Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: DWJ1248 with Remdesivir Camostat mesylate 200 mg, Remdesivir |
Drug: DWJ1248 with Remdesivir
PO, 1 tablet of DWJ1248 TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
|
Placebo Comparator: Placebo with Remdesivir Placebo, Remdesivir |
Drug: Placebo with Remdesivir
PO, 1 tablet of placebo TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
|
Outcome Measures
Primary Outcome Measures
- Rate of mortality or ECMO patients [Up to 29 days]
Percentage of patients with mortality(ordinal scale of 8) or ECMO patients(ordinal scale of 7)
Secondary Outcome Measures
- Recovery days [Day 3,5,8,11,15,22,29]
- Desirable of Outcome Ranking (DOOR) [Day 15,29]
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
- Hospitalization period [Day 29]
The duration of hospitalization (days)
- Rate of Mortality [Day 15,29]
The percent of participants
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults over the age of 19 as of the signed date in written consent
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Subjects with COVID-19 according to RT-PCR test(within 10 days)
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Subjects who need to be hospitalized and injected Remdesivir
Exclusion Criteria:
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Subjects who cannot orally administer the investigational products
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Subjects who requiring mechanical ventilation or ECMO
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Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
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Subjects who need administration of immunosuppressants
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Subjects who are allergic or sensitive to investigational products or its ingredients
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Crcl < 30 mL/min or eGFR < 30 mL/min/1.73m^2
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AST or ALT >= 5xULN
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | National Medical Center | Seoul | Korea, Republic of | 04564 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWJ1248302