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Termination of study due to sponsor's internal decision
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Efficacy and Safety of DWJ1248 with Remdesivir in Severe COVID-19 Patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1248 with Remdesivir | Experimental | Camostat mesylate 200 mg, Remdesivir |
|
| Placebo with Remdesivir | Placebo Comparator | Placebo, Remdesivir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1248 with Remdesivir | Drug | 1 tablet of DWJ1248 TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Center | Seoul | 04564 | South Korea |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000606551 | remdesivir |
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| Placebo with Remdesivir | Drug | 1 tablet of placebo TID(up to 14 days) PO, Remdesivir(up to 5 or 10 days) IV |
|
| Day 15,29 |
| Duration of Hospitalization | The duration of hospitalization (days) | Day 29 |
| Time to death | The percent of participants | Day 15,29 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |