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This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Cohort 1: It is designed as a two stage, multi-center, randomized, double-blind, two parallel doses, placebo-controlled study that will investigate the efficacy of DAS181 for the treatment of serious IFV in hospitalized patients who suffered from acute hypoxemia requiring supplemental oxygen therapy.
Cohort 2: It is designed as an open-label study that will investigate the efficacy of DAS181 for the treatment of patients with sever IFV but not eligible for Cohort 1 and non-IFV SAD viral infection, e.g. parainfluenza virus, human metapneumovirus, enterovirus and all strains of β-coronaviruses (including but not limited to SARS-CoV-2), with hypoxemia requiring supplemental oxygen therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAS181 SD group Cohort 1, Stage 1 | Experimental | DAS181 SD group 4.5mg/day for 7 or 10 days |
|
| DAS181 HD group Cohort 1, Stage 1 | Experimental | DAS181 HD group 9mg/day for 7 or 10 days. |
|
| Placebo, Cohort 1, Stage 1 | Placebo Comparator | Placebo 0mg/day for 7 or 10 days |
|
| DAS181 group, Cohort 1, Stage 2 | Experimental | DAS181 4.5mg/day or 9mg/day. Dosage will be determined after completion of stage 1. |
|
| Placebo, Cohort 1, Stage 2 | Placebo Comparator | Placebo 0mg/day for 7 or 10 days |
|
| DAS181 group, Cohort 2, Stage1 and 2 | Experimental | DAS181 4.5mg/day or 9mg/day for 7 or 10 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAS181 | Drug | SD (4.5mg/day), HD (9mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of subjects who have returned to room air | Percent of subjects who have returned to room air | 7 days |
| Percent change of subjects return to baseline oxygen requirement | Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1 | 7 days |
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Inclusion criteria of Cohort 1 #4 is adapted from the Flu guideline in China (2018) and community acquired pneumonia (CAP) guideline in China (2016)
Cohort 1:
Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:
Cohort 2:
Subjects must meet all of the following inclusion criteria at the time of randomization to be eligible for participation in this study:
Males and Females ≥18 years old
Hypoxemia
Subjects fulfill one of the following conditions:
Same in inclusion criteria #5 to #8 in Cohort 1.
Exclusion Criteria
Cohort 1 and 2:
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivy Fan | Contact | +86 186 2190 9313 | ifan@ansunbiopharma.com | |
| Sylvie Lu-Hinh | Contact | 858-452-2631 | 199 | slu-hinh@ansunbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Ho, MD, PhD | Ansun Biopharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007239 | Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C525612 | oplunofusp |
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Stage 2, Ansun will know the dosage.
|
| Placebo | Drug | Placebo 0mg/day |
|
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |