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| Name | Class |
|---|---|
| Rinati Skin, LLC | UNKNOWN |
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This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ResCure™ | Biological | Patients will be treated with nebulized ResCure™ |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of recovery of mild or moderate COVID-19 in patients using ResCure™ | Number of days from COVID-19 diagnosis to recovery via RT-PCR | 12 Weeks |
| Reduction or progression of symptomatic days | Reduction and/or progression of symptomatic days, reduction of symptom severity | 12 Weeks |
| Assess the safety of ResCure™ via pulse | Pulse from baseline to 12 weeks | 12 Weeks |
| Assess the safety of ResCure™ via oxygen saturation | Oxygen saturation from baseline to 12 weeks | 12 Weeks |
| Assess the safety of ResCure™ via EKG | EKG from baseline to 12 weeks | 12 Weeks |
| Assess Tolerability of ResCure™ | Assess Adverse Events and Serious Adverse Events due to ResCure™ | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients less than 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Hazan, MD | ProgenaBiome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProgenaBiome | Ventura | California | 93003 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |