A Study of ResCure™ to Treat COVID-19 Infection
Purpose
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.
Conditions
- COVID
- Covid-19
- Corona Virus Infection
- Sars-CoV2
- Coronavirus-19
- SARS Pneumonia
- SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Critically ill patients with SARS from COVID-19 infection on respirators OR 2. Patients with SARS from COVID-19 infection prior or after being placed on respirator 3. Male or female patients 18 years of age and older
Exclusion Criteria
- Patients less than 18 years of age
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment Group |
This group will be treated with nebullized ResCure™ while hospitalized every 4 to 6 hours, depending on disease severity and ventilator status. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04395716
- Status
- Withdrawn
- Sponsor
- ProgenaBiome
Detailed Description
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.