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Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
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This study is designed to assess the safety and tolerability of single doses of DWRX2003 in COVID-19 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort 1 (96 mg) | Experimental | 24 mg/0.1 mL x 4 sites |
|
| Experimental: Cohort 2 (288 mg) | Experimental | 72 mg/0.3 mL x 4 sites |
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| Experimental: Cohort 3 (480 mg) | Experimental | 120 mg/0.5 mL x 4 sites |
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| Experimental: Cohort 4 (672 mg) | Experimental | 168 mg/0.7 mL x 4 sites |
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| Experimental: Cohort 5 (960 mg) | Experimental | 240 mg/1.0 mL x 4 sites |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWRX2003 | Drug | Intramuscularly injection at pre-defined injection sites |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) | follow-up 42 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Time to SARS-CoV-2 eradication (days) by Nasopharyngeal specimen | follow-up 42 days after dosing | |
| Rate of SARS-CoV-2 eradication by Nasopharyngeal specimen | at Day 3, 7, 10 and 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deawoong pharmaceutical | Seoul | Gangnam-gu | 06170 | South Korea |
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| Placebo | Drug | Intramuscularly injection at pre-defined injection sites |
|