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| Name | Class |
|---|---|
| Ansun Biopharma, Inc. | INDUSTRY |
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The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.
From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS181 Treatment | Experimental | Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAS181 | Drug | Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improved clinical status | Percent of subjects with improved clinical status | Day 14 |
| Return to room air | Percent of subjects return to room air | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 RNA | time to SARS-CoV-2 RNA in the respiratory specimens being undetectable | 28 days |
| Discharge | Percent of patients discharge from hospital |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zuojiong Gong, MD | Renmin Hospital of Wuhan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C525612 | oplunofusp |
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| Days 14, 21, 28 |
| Death | All-cause mortality rate | Day 14, 21, 28 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |