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Changes in drug development plans
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To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1248 | Experimental | Camostat mesylate |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1 | Other | - DWJ1248 600mg PO (100mg 2 tab, TID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| (Part 1) Time to SARS-CoV-2 eradication | Time to reach undetectable SARS-CoV-2 RNA level | Up to 28 days |
| (Part 2) Time to clinical improvement of subjective symptoms | Clinical improvement of subjective symptoms (days) | Up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| (Part 1) Rate of SARS-CoV-2 eradication | Percent of patients with undetectable SARS-CoV-2 RNA level | Days 4, 7, 10, and 14 |
| (Part 1/2) Time to clinical improvement of subjective symptoms | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36515544 | Derived | Kim YS, Jeon SH, Kim J, Koh JH, Ra SW, Kim JW, Kim Y, Kim CK, Shin YC, Kang BD, Kang SJ, Park CH, Lee B, Lee JY, Lee CH, Choi JP, Kim JY, Yu SN, Peck KR, Kim SH, Heo JY, Kim HA, Park HJ, Choi J, Han J, Kim J, Kim HJ, Han SH, Yoon A, Park M, Park S, Kim Y, Jung M, Oh MD. A Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study To Evaluate the Efficacy and Safety of Camostat Mesylate (DWJ1248) in Adult Patients with Mild to Moderate COVID-19. Antimicrob Agents Chemother. 2023 Jan 24;67(1):e0045222. doi: 10.1128/aac.00452-22. Epub 2022 Dec 14. |
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| Part 2 |
| Other |
- DWJ1248 600mg PO (200mg 1 tab, TID) |
|
| (Part 2) Change from baseline of subjective symptom scores | Days 4, 7, 10, 14, 21 and 28 |